0A4F4F9BD490A749D5437F821CF06DF1
Directive 93/42/EEC Concerning Medical Devices
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
http://leaux.net/URLS/ConvertAPI Text Files/4964965CE249B1140F4615ADF5479ADC.en.txt
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
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p.(None): (a) to refuse or restrict the placing on the market or the putting into service of a device or the
p.(None): carrying out of clinical investigations;
p.(None): or
p.(None): (b) to withdraw devices from the market,
p.(None): shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the
p.(None): party concerned, who shall at the same time be informed of the remedies available to him under the national
p.(None): law in force in the Member State in question and of the time limits to which such remedies are
p.(None): subject.
p.(None): 2. In the event of a decision as referred to in paragraph 1, the
p.(None): manufacturer, or his authorized representative ►M5 ◄,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None): shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not
p.(None): possible because of the urgency of the measure to be taken.
p.(None): Article 20
p.(None): Confidentiality
p.(None):
p.(None): 1. Without prejudice to the existing national provisions and practices on medical confidentiality, Member
p.(None): States shall ensure that all the Parties involved in the application of this Directive are bound
p.(None): to observe confidentiality with regard to all information obtained in carrying out their tasks.
p.(None): This does not affect the obligation of Member States and notified bodies with regard to mutual information and
p.(None): the dissemination of warnings, nor the obligations of the persons concerned to provide information under
p.(None): criminal law.
p.(None): 2. The following information shall not be treated as confidential:
p.(None): (a) information on the registration of persons responsible for placing devices on the market in
p.(None): accordance with Article 14;
p.(None): (b) information to users sent out by the manufacturer, authorised repre- sentative or distributor in relation
p.(None): to a measure according to Article 10(3);
p.(None): (c) information contained in certificates issued, modified, supple- mented, suspended or withdrawn.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 22
p.(None):
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p.(None): ▼M5
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p.(None): ▼B
p.(None):
p.(None):
p.(None): 3. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing
p.(None): it, relating to determination of the conditions under which other information may be made publicly
p.(None): available, and in particular for Class IIb and Class III devices to any obligation for manufacturers to
p.(None): prepare and make available a summary of the information and data related to the device, shall be
p.(None): adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
p.(None):
p.(None): Article 20a
p.(None): Cooperation
p.(None):
p.(None): Member States shall take appropriate measures to ensure that the competent authorities of the
p.(None): Member States cooperate with each other and with the Commission and transmit to each other the
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Political / political affiliation
Searching for indicator party:
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p.(None): professional qualifications to do so.
p.(None): Mass-produced devices which need to be adapted to meet the specific requirements of the medical
p.(None): practitioner or any other professional user ►M5 shall not be ◄ considered to be custom- made devices;
p.(None): (e) ‘device intended for clinical investigation’ means any device intended for use by a duly
p.(None): qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in
p.(None): an adequate human clinical environment.
p.(None): For the purpose of conducting clinical investigation, any other person who, by virtue of his
p.(None): professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent
p.(None): to a duly qualified medical practitioner;
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 7
p.(None):
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p.(None): ▼B
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p.(None): (f) ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging
p.(None): and labelling of a device before it is placed on the market under his own name, regardless of whether these
p.(None): operations are carried out by that person himself or on his behalf by a third party.
p.(None): The obligations of this Directive to be met by manufacturers also apply to the natural or legal person
p.(None): who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or
p.(None): assigns to them their intended purpose as a device with a view to their being placed on the market under his
p.(None): own name. This subparagraph does not apply to the person who, while not a manufacturer within the
p.(None): meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for
p.(None): an individual patient;
p.(None): (g) ‘intended purpose’ means the use for which the device is intended according to the data supplied by the
p.(None): manufacturer on the labelling, in the instructions and/or in promotional materials;
p.(None): (h) ‘placing on the market’ means the first making available in return for payment or free of charge
p.(None): of a device other than a device intended for clinical investigation, with a view to distribution
p.(None): and/or use on the Community market, regardless of whether it is new or fully refurbished;
p.(None):
p.(None): (i) ‘putting into service’ means the stage at which a device has been made available to the final
p.(None): user as being ready for use on the Community market for the first time for its intended purpose;
p.(None): (j) ‘authorised representative’ means any natural or legal person estab- lished in the Community who,
p.(None): explicitly designated by the manu- facturer, acts and may be addressed by authorities and bodies in the Community
p.(None): instead of the manufacturer with regard to the latter's obligations under this Directive;
p.(None):
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p.(None):
p.(None): Without prejudice to Article 8:
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 21
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p.(None): ▼B
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p.(None):
p.(None): (a) where a Member State establishes that the CE marking has been affixed unduly or is missing in violation
p.(None): of the Directive, the manu- facturer or his authorised representative shall be obliged to end the
p.(None): infringement under conditions imposed by the Member State;
p.(None):
p.(None): (b) where non-compliance continues, the Member State must take all appropriate measures to restrict or
p.(None): prohibit the placing on the market of the product in question or to ensure that it is
p.(None): withdrawn from the market, in accordance with the procedure in Article 8.
p.(None):
p.(None): Those provisions shall also apply where the CE marking has been affixed in accordance with the
p.(None): procedures in this Directive, but inap- propriately, on products that are not covered by this Directive.
p.(None):
p.(None): Article 19
p.(None): Decision in respect of refusal or restriction
p.(None):
p.(None): 1. Any decision taken pursuant to this Directive:
p.(None): (a) to refuse or restrict the placing on the market or the putting into service of a device or the
p.(None): carrying out of clinical investigations;
p.(None): or
p.(None): (b) to withdraw devices from the market,
p.(None): shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the
p.(None): party concerned, who shall at the same time be informed of the remedies available to him under the national
p.(None): law in force in the Member State in question and of the time limits to which such remedies are
p.(None): subject.
p.(None): 2. In the event of a decision as referred to in paragraph 1, the
p.(None): manufacturer, or his authorized representative ►M5 ◄,
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None): shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not
p.(None): possible because of the urgency of the measure to be taken.
p.(None): Article 20
p.(None): Confidentiality
p.(None):
p.(None): 1. Without prejudice to the existing national provisions and practices on medical confidentiality, Member
p.(None): States shall ensure that all the Parties involved in the application of this Directive are bound
p.(None): to observe confidentiality with regard to all information obtained in carrying out their tasks.
p.(None): This does not affect the obligation of Member States and notified bodies with regard to mutual information and
p.(None): the dissemination of warnings, nor the obligations of the persons concerned to provide information under
p.(None): criminal law.
p.(None): 2. The following information shall not be treated as confidential:
p.(None): (a) information on the registration of persons responsible for placing devices on the market in
p.(None): accordance with Article 14;
p.(None): (b) information to users sent out by the manufacturer, authorised repre- sentative or distributor in relation
p.(None): to a measure according to Article 10(3);
...
p.(None): this Directive.
p.(None): Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed
p.(None): at an international level.
p.(None):
p.(None): Article 21
p.(None): Repeal and amendment of Directives
p.(None):
p.(None): 1. Directive 76/764/EEC is hereby repealed with effect from 1 January 1995.
p.(None): 2. In the title and Article 1 of Directive 84/539/EEC, ‘human or’ is deleted.
p.(None): In Article 2 of Directive 84/539/EEC, the following subparagraph is added to paragraph 1:
p.(None): ‘If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC (*)
p.(None): and if it satisfies the essential requirements laid down therein for that device, the device shall be
p.(None): deemed to be in conformity with the requirements of this Directive.
p.(None):
p.(None): (*) OJ No L 169, 12.7.1993, p. 1.’
p.(None):
p.(None): 3. Directive 90/385/EEC is hereby amended as follows:
p.(None): 1. in Article 1 (2) the following two subparagraphs are added:
p.(None): ‘(h) “placing on the market” means the first making available in return for payment or free of charge
p.(None): of a device other than a device intended for clinical investigation, with a view to distri- bution and/or use
p.(None): on the Community market, regardless of whether it is new or fully refurbished;
p.(None): (i) “manufacturer” means the natural or legal person with respon- sibility for the design, manufacture,
p.(None): packaging and labelling of a device before it is placed on the market under his own name, regardless of whether
p.(None): these operations are carried out by that person himself or on his behalf by a third party.
p.(None): The obligations of this Directive to be met by manufacturers also apply to the natural or legal
p.(None): person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made
p.(None): products and/or assigns to them their intended purpose as a device with a view to their
p.(None): being placed on the market under his own name. This subparagraph
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 23
p.(None):
p.(None): ▼B
p.(None): does not apply to the person who, while not a manufacturer within the meaning of the first
p.(None): subparagraph, assembles or adapts devices already on the market to their intended purpose for an
p.(None): individual patient;’
p.(None): 2. in Article 9 the following paragraphs are added:
p.(None): ‘5. During the conformity assessment procedure for a device, the manufacturer and/or the notified body
p.(None): shall take account of the results of any assessment and verification operations which, where appropriate,
p.(None): have been carried out in accordance with this Directive at an intermediate stage of manufacture.
p.(None): 6. Where the conformity assessment procedure involves the inter- vention of a notified body, the manufacturer, or
p.(None): his authorized repre- sentative established in the Community, may apply to a body of his choice within the framework
p.(None): of the tasks for which the body has been notified.
p.(None): 7. The notified body may require, where duly justified, any infor- mation or data which is necessary for
p.(None): establishing and maintaining the attestation of conformity in view of the chosen procedure.
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p.(None): manuals and quality records.
p.(None):
p.(None): It shall include in particular the corresponding documentation, data and records arising from the
p.(None): procedures referred to in point (c).
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 34
p.(None):
p.(None):
p.(None): ▼B
p.(None):
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p.(None):
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p.(None): ▼B
p.(None):
p.(None):
p.(None): It shall include in particular an adequate description of:
p.(None): (a) the manufacturer's quality objectives;
p.(None): (b) the organization of the business and in particular:
p.(None): — the organizational structures, the responsibilities of the managerial staff and their organizational
p.(None): authority where quality of design and manufacture of the products is concerned,
p.(None): — the methods of monitoring the efficient operation of the quality system and in particular its ability
p.(None): to achieve the desired quality of design and of product, including control of products which fail to
p.(None): conform,
p.(None):
p.(None): — where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried
p.(None): out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the
p.(None): type and extent of control applied to the third party;
p.(None): (c) the procedures for monitoring and verifying the design of the products, including the corresponding
p.(None): documentation, and in particular:
p.(None): — a general description of the product, including any variants planned, and its intended use(s),
p.(None): — the design specifications, including the standards which will be applied and the results of the risk
p.(None): analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply
p.(None): to the products if the standards referred to in Article 5 are not applied in full,
p.(None): — the techniques used to control and verify the design and the processes and systematic
p.(None): measures which will be used when the products are being designed,
p.(None): — if the device is to be connected to other device(s) in order to operate as intended, proof must be
p.(None): provided that it conforms to the essential requirements when connected to any such device(s) having the
p.(None): characteristics specified by the manufacturer,
p.(None): — a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood
p.(None): derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection
p.(None): required to assess the safety, quality and usefulness of that substance or human blood derivative, taking
p.(None): account of the intended purpose of the device,
p.(None): — a statement indicating whether or not the device is manufactured utilising tissues of animal origin as
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p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 43
p.(None):
p.(None):
p.(None): ▼B
p.(None):
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p.(None): ▼M5
p.(None):
p.(None):
p.(None): quality policy and procedures such as quality programmes, plans, manuals and records.
p.(None): It must include in particular an adequate description of:
p.(None): (a) the manufacturer's quality objectives;
p.(None): (b) the organization of the business and in particular:
p.(None): — the organizational structures, the responsibilities of the managerial staff and their organizational
p.(None): authority where manufacture of the products is concerned,
p.(None):
p.(None): — the methods of monitoring the efficient operation of the quality system and in particular its ability
p.(None): to achieve the desired quality of product, including control of products which fail to conform,
p.(None):
p.(None):
p.(None): — where the manufacture and/or final inspection and testing of the products, or elements thereof, are
p.(None): carried out by a third party, the methods of monitoring the efficient operation of the quality system and in
p.(None): particular the type and extent of control applied to the third party;
p.(None):
p.(None):
p.(None): (c) the inspection and quality assurance techniques at the manufacturing stage and in particular:
p.(None): — the processes and procedures which will be used, particularly as regards sterilization, purchasing and
p.(None): the relevant documents,
p.(None): — the product identification procedures drawn up and kept up to date from drawings, specifications or other
p.(None): relevant documents at every stage of manufacture;
p.(None):
p.(None): (d) the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with
p.(None): which they will take place, and the test equipment used; it must be possible adequately to trace back
p.(None): the calibration of the test equipment.
p.(None):
p.(None): 3.3. The notified body must audit the quality system to determine whether it meets the requirements
p.(None): referred to in Section 3.2. It must presume that quality systems which implement the relevant
p.(None): harmonized standards conform to these requirements.
p.(None):
p.(None): The assessment team must include at least one member with past experience of assessments of the
p.(None): technology concerned. The assessment procedure must include an inspection on the manufacturer's premises
p.(None): and, in duly substantiated cases, on the premises of the manufacturer's suppliers to inspect the manufacturing
p.(None): processes.
p.(None):
p.(None): The decision must be notified to the manufacturer after the final inspection and contain the conclusions of the
p.(None): inspection and a reasoned assessment.
p.(None):
p.(None): 3.4. The manufacturer must inform the notified body which approved the quality system of any
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p.(None):
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p.(None): ▼B
p.(None):
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p.(None): ▼B
p.(None):
p.(None):
p.(None): (s) referred to in Article 5 or equivalent tests are carried out to ensure that the products conform to the type
p.(None): described in the EC type-examination certificate and fulfil the provisions of this Directive which apply
p.(None): to them. All the elements, requirements and provisionsadopted by the manufacturer must be documented in a
p.(None): systematic and orderly manner in the form of written measures, procedures and instructions. This quality
p.(None): system docu- mentation must permit uniform interpretation of the quality programmes, quality plans, quality
p.(None): manuals and quality records.
p.(None): It must include in particular an adequate description of:
p.(None): — the quality objectives and the organizational structure, responsibilities and powers of the managerial
p.(None): staff with regard to product quality,
p.(None): — the examinations and tests that will be carried out after manufacture; it must be possible to trace back the
p.(None): calibration of the test equipment adequately,
p.(None): — the methods of monitoring the efficient operation of the quality system,
p.(None): — the quality records, such as reports concerning inspections, tests, cali- bration and the qualifications
p.(None): of the staff concerned, etc.,
p.(None):
p.(None): — where the final inspection and testing of the products, or elements thereof, are carried out by a
p.(None): third party, the methods of monitoring the efficient operation of the quality system and in particular
p.(None): the type and extent of control applied to the third party.
p.(None):
p.(None): The aforementioned checks do not apply to those aspects of the manufac- turing process designed to
p.(None): secure sterility.
p.(None): 3.3. The notified body audits the quality system to determine whether it meets the requirements referred
p.(None): to in section 3.2. It must presume that quality systems which implement the relevant harmonized
p.(None): standards conform to these requirements.
p.(None): The assessment team must include at least one member with past experience of assessments of the
p.(None): technology concerned. The assessment procedure must include an inspection on the manufacturer's premises
p.(None): and, in duly substantiated cases, on the premises of the manufacturer's suppliers to inspect the manufacturing
p.(None): processes.
p.(None): The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and
p.(None): a reasoned assessment.
p.(None): 3.4. The manufacturer must inform the notified body which approved the quality system of any
p.(None): plan for substantial changes to the quality system.
p.(None): The notified body must assess the changes proposed and verify whether after these changes the quality
p.(None): system will still meet the requirements referred to in Section 3.2.
p.(None): After receiving the abovementioned information it must notify the manu- facturer of its decision. This
p.(None): decision must contain the conclusions of the inspection and a reasoned assessment.
p.(None): 4. Surveillance
p.(None): 4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by
p.(None): the approved quality system.
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Political / stateless persons
Searching for indicator nation:
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p.(None): the purpose of carrying out the clinical investigations, appropriate means have to be specified for the
p.(None): protection of public health and public order;
p.(None): Whereas the protection of health and the associated controls may be made more effective by means of
p.(None): medical device vigilance systems which are integrated at Community level;
p.(None): Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the
p.(None): approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers (2);
p.(None): whereas the abovementioned Directive must therefore be repealed; whereas for the same reasons Council
p.(None): Directive 84/539/ EEC on 17 September 1984 on the approximation of the laws of the Member States
p.(None): relating to electro-medical equipment used in human or veterinary medicine (3) must be amended,
p.(None):
p.(None): HAS ADOPTED THIS DIRECTIVE:
p.(None):
p.(None): Article 1
p.(None): Definitions, scope
p.(None):
p.(None): 1. This Directive shall apply to medical devices and their accessories. For the purposes of this
p.(None): Directive, accessories shall be treated as medical devices in their own right. Both medical devices
p.(None): and acces- sories shall hereinafter be termed devices.
p.(None): 2. For the purposes of this Directive, the following definitions shall apply:
p.(None): (a) ►M5 ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether
p.(None): used alone or in combi- nation, including the software intended by its manufacturer to be used specifically
p.(None): for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the
p.(None): manufacturer to be used for human beings for the purpose of: ◄
p.(None): — diagnosis, prevention, monitoring, treatment or alleviation of disease,
p.(None):
p.(None): (1) OJ No C 185, 22.7.1989, p. 8.
p.(None): (2) OJ No L 262, 27.9.1976, p. 139. Directive as last amended by Directive 84/414/EEC (OJ No L 228,
p.(None): 25.8.1984, p. 25).
p.(None): (3) OJ No L 300, 19.11.1984, p. 179. Directive as amended by the Act of Accession of Spain and
p.(None): Portugal.
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 6
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
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p.(None):
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p.(None): ▼B
p.(None):
p.(None):
p.(None): — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
p.(None): — investigation, replacement or modification of the anatomy or of a physiological process,
p.(None): — control of conception,
p.(None): and which does not achieve its principal intended action in or on the human body by pharmacological,
p.(None): immunological or metabolic means, but which may be assisted in its function by such means;
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Political / vulnerable
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p.(None): general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission
p.(None): should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to
p.(None): be taken must be defined in line with procedure I, as laid down in Council Decision
p.(None): 87/373/EEC (2); whereas, for specific fields, what already exists in the form of European
p.(None): Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore,
p.(None): several European Pharmacopoeia monographs may be considered equal to the abovemen- tioned harmonized standards;
p.(None): Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases
p.(None): of the conformity assessment procedures which are intended to be used in the technical harmonization directives
p.(None): (3), the Council has laid down harmonized conformity assessment procedures; whereas the application
p.(None): of these modules to medical devices enables the responsibility of manufacturers and notified bodies
p.(None): to be determined during conformity assessment procedures on the basis of the type of devices
p.(None): concerned; whereas the details added to these modules are justified by the nature of the verifi- cation
p.(None): required for medical devices;
p.(None): Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group
p.(None): the devices into four product classes; whereas the classification rules are based on the vulnerability of
p.(None): the human body taking account of the potential risks associated with the technical design and
p.(None): manufacture of the devices; whereas the conformity assessment procedures for Class I devices can
p.(None): be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of
p.(None): vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified
p.(None): body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and
p.(None): III which constitute a high risk potential, inspection by a notified body is required with regard
p.(None): to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for
p.(None): which explicit prior authorization with regard to conformity is required for them to be placed on the
p.(None): market;
p.(None): Whereas in cases where the conformity of the devices can be assessed under the responsibility of the
p.(None): manufacturer the competent authorities must be able, particularly in emergencies, to contact a
p.(None): person responsible for placing the device on the market and established in the Community, whether the
p.(None): manufacturer or another person established in the Community and designated by the manufacturer for the purpose;
p.(None): Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of
p.(None): this Directive to enable
p.(None):
p.(None): (1) OJ No L 109, 26.4.1983, p. 8. Directive as last amended by Commission Decision 92/400/EEC (OJ No L
p.(None): 221, 6.8.1992, p. 55).
p.(None): (2) OJ No L 197, 18.7.1987, p. 33.
p.(None): (3) OJ No L 147, 9.6.1975, p. 1. Directive as last amended by Directive 91/507/ EEC (OJ No L 270, 26.9.1991, p.
p.(None): 32).
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 5
p.(None):
p.(None): ▼B
...
Health / Drug Usage
Searching for indicator influence:
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p.(None): III,
p.(None): — or to supply energy in the form of ionizing radiation in which case they are in Class IIb,
p.(None): — or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class
p.(None): III,
p.(None): — or to undergo chemical change in the body, except if the devices are placed in the teeth, or to
p.(None): administer medicines, in which case they are in Class IIb.
p.(None): 2.4. Rule 8
p.(None): All implantable devices and long-term surgically invasive devices are in Class IIb unless they are
p.(None): intended:
p.(None): — to be placed in the teeth, in which case they are in Class IIa,
p.(None): — to be used in direct contact with the heart, the central circulatory system or the central nervous system, in
p.(None): which case they are in Class III,
p.(None): — to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III,
p.(None): — or to undergo chemical change in the body, except if the devices are placed in the teeth, or to
p.(None): administer medicines, in which case they are in Class III.
p.(None): 3. Additional rules applicable to active devices
p.(None): 3.1. Rule 9
p.(None): All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics
p.(None): are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking
p.(None): account of the nature, the density and site of application of the energy, in which case they are in
p.(None): Class IIb.
p.(None): All active devices intended to control or monitor the performance of active therapeutic devices in Class
p.(None): IIb, or intended directly to influence the performance of such devices are in Class IIb.
p.(None): 3.2. Rule 10
p.(None): Active devices intended for diagnosis are in Class IIa:
p.(None): — if they are intended to supply energy which will be absorbed by the human body, except for devices used
p.(None): to illuminate the patient's body, in the visible spectrum,
p.(None): — if they are intended to image in vivo distribution of radiopharmaceu- ticals,
p.(None): — if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless
p.(None): they are specifically intended for moni- toring of vital physiological parameters, where the nature of variations
p.(None): is such that it could result in immediate danger to the patient, for instance variations in cardiac performance,
p.(None): respiration, activity of CNS in which case they are in Class IIb.
p.(None): Active devices intended to emit ionizing radiation and intended for diag- nostic and therapeutic
p.(None): interventional radiology including devices which control or monitor such devices, or which
p.(None): directly influence their performance, are in Class IIb.
p.(None): Rule 11
p.(None): All active devices intended to administer and/or remove medicines, body liquids or other substances to or from
p.(None): the body are in Class IIa, unless this is done in a manner:
p.(None): — that is potentially hazardous, taking account of the nature of the substances involved, of
p.(None): the part of the body concerned and of the mode of application in which case they are in Class IIb.
p.(None): 3.3. Rule 12
p.(None): All other active devices are in Class I.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 56
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 4. Special Rules
p.(None): 4.1. Rule 13
p.(None): All devices incorporating, as an integral part, a substance which, if used separately, can be considered
p.(None): to be a medicinal product, as defined in Article 1 of Directive ►M5 2001/83/EC ◄, and which is liable
p.(None): to act on the human body with action ancillary to that of the devices, are in Class III.
p.(None):
p.(None): All devices incorporating, as an integral part, a human blood derivative are in Class III.
p.(None):
p.(None): 4.2. Rule 14
p.(None): All devices used for contraception or the prevention of the transmission of sexually transmitted diseases
p.(None): are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class
p.(None): III.
p.(None): 4.3. Rule 15
...
p.(None): another authorized qualified person in an appro- priate environment.
p.(None): The medical practitioner or other authorized person must have access to the technical and clinical data
p.(None): regarding the device.
p.(None): 2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must
p.(None): contain a critical evaluation of all the data collected during the clinical investigation.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 59
p.(None):
p.(None): ▼B
p.(None): ANNEX XI
p.(None):
p.(None): CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES
p.(None):
p.(None): 1. The notified body, its Director and the assessment and verification staff shall not be the designer,
p.(None): manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative
p.(None): of any of these persons. They may not be directly involved in the design, construction, marketing or
p.(None): maintenance of the devices, nor represent the parties engaged in these activities. This in no
p.(None): way precludes the possibility of exchanges of technical information between the manufacturer and
p.(None): the body.
p.(None): 2. The notified body and its staff must carry out the assessment and verification operations with the highest
p.(None): degree of professional integrity and the requisite competence in the field of medical devices and
p.(None): must be free from all pressures and inducements, particularly financial, which might influence
p.(None): their judgment or the results of the inspection, especially from persons or groups of persons with an
p.(None): interest in the results of the verifications.
p.(None): Should the notified body subcontract specific tasks connected with the estab- lishment and verification of the
p.(None): facts, it must first ensure that the subcon- tractor meets the provisions of the Directive and, in particular,
p.(None): of this Annex. The notified body shall keep at the disposal of the national authorities the relevant
p.(None): documents assessing the subcontractor's qualifications and the work carried out by the subcontractor under
p.(None): this Directive.
p.(None): 3. The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes
p.(None): II to VI and for which it has been notified, whether these tasks are carried out by the body itself or on
p.(None): its responsibility. In particular, it must have the necessary staff and possess the facilities needed to
p.(None): perform properly the technical and administrative tasks entailed in assessment and verification.
p.(None): ►M1 This presupposes the availability of sufficient scientific staff within the organisation who
p.(None): possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which
p.(None): it has been notified, having regard to the requirements of this Directive and, in particular, those set out in
p.(None): Annex I. ◄ It must also have access to the equipment necessary for the verifications required.
p.(None): 4. The notified body must have:
...
Searching for indicator substance:
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p.(None): Whereas medical devices should provide patients, users and third parties with a high level of protection
p.(None): and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the
p.(None): main- tenance or improvement of the level of protection attained in the Member States is one of
p.(None): the essential objectives of this Directive;
p.(None): Whereas certain medical devices are intended to administer medicinal products within the meaning of
p.(None): Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law,
p.(None): regulation or administrative action relating to proprietary medicinal products (4); whereas, in such
p.(None): cases, the placing on the market of the medical device as a general rule is governed by the present
p.(None): Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC;
p.(None): whereas if, however, such a device is placed on the market in such a way that the device and the medicinal
p.(None): product form a single integral unit which is intended exclusively for use in the given combination and which is not
p.(None): reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn
p.(None): between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately,
p.(None): may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such
p.(None): cases, if the substances incorporated in the medical devices are liable to act upon the body with
p.(None): action ancillary to that of the device, the placing of the devices on the market is governed by
p.(None):
p.(None): (1) OJ No C 237, 12.9.1991 and OJ No C 251, 28.9.1992, p. 40.
p.(None): (2) OJ No C 150, 31.5.1993 and OJ No C 176, 28.6.1993.
p.(None): (3) OJ No C 79, 30.3.1992, p. 1.
p.(None): (4) OJ No 22, 9.6.1965, p. 369/65. Directive as last amended by Directive 92/27/ EEC (OJ No L 113, 30.4.1992, p.
p.(None): 8).
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 3
p.(None):
p.(None): ▼B
p.(None): this Directive; whereas, in this context, the safety, quality and usefulness of the substances
p.(None): must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20
p.(None): May 1975 on the approximation of the laws of the Member States relating to analytical,
p.(None): pharmaco-toxicological and clinical standards and protocols in respect of the testing of
p.(None): proprietary medicinal products (1);
p.(None): Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any
p.(None): reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of
p.(None): technology and practice existing at the time of design and of technical and economical considerations compatible with a
p.(None): high level of protection of health and safety;
...
p.(None): (n) ‘single use device’ means a device intended to be used once only for a single patient.
p.(None): 3. Where a device is intended to administer a medicinal product within the meaning of Article 1
p.(None): of Directive 2001/83/EC (1), that
p.(None):
p.(None): (1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.(None): Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). Directive as
p.(None): last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 8
p.(None):
p.(None): ▼M5
p.(None): device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC
p.(None): with regard to the medicinal product.
p.(None):
p.(None): If, however, such a device is placed on the market in such a way that the device and the medicinal
p.(None): product form a single integral product which is intended exclusively for use in the given combination
p.(None): and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The
p.(None): relevant essential requirements of Annex I to this Directive shall apply as far as safety and
p.(None): performance-related device features are concerned.
p.(None):
p.(None): ▼B
p.(None): 4. Where a device incorporates, as an integral part, a substance which, if used separately, may be
p.(None): considered to be a medicinal product within the meaning of Article 1 of Directive ►M5 2001/83/EC ◄ and
p.(None): which is liable to act upon the body with action ancillary to that of the device, ►M5 that device shall ◄ be
p.(None): assessed and authorized in accordance with this Directive.
p.(None):
p.(None):
p.(None): ▼M2
p.(None):
p.(None): 4 a. Where a device incorporates, as an integral part, a substance which, if used separately,
p.(None): may be considered to be a medicinal product constituent or a medicinal product derived from human
p.(None): blood or human plasma within the meaning of Article 1 of Directive
p.(None): ►M5 2001/83/EC ◄ and which is liable to act upon the human body with action ancillary to that of
p.(None): the device, hereinafter referred to as a ‘human blood derivative’, ►M5 that device shall ◄ be assessed
p.(None): and authorised in accordance with this Directive.
p.(None):
p.(None): ▼B
p.(None): 5. ►M5 This Directive shall not apply to: ◄
p.(None):
p.(None): (a) in vitro diagnostic devices;
p.(None):
p.(None): (b) active implantable devices covered by Directive 90/385/EEC;
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): (c) medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under
p.(None): that Directive or this Directive, particular account shall be taken of the principal mode of action
p.(None): of the product;
p.(None):
p.(None): ▼B
p.(None): (d) cosmetic products covered by Directive 76/768/EEC (1);
p.(None):
p.(None):
p.(None): ▼M3
p.(None):
p.(None): (e) human blood, blood products, plasma or blood cells of human origin or to devices which incorporate
p.(None): at the time of placing on the market such blood products, plasma or cells, with the exception of devices
p.(None): referred to in paragraph 4a;
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): (f) transplants or tissues or cells of human origin nor to products incorporating or derived from
p.(None): tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
p.(None):
p.(None): ▼B
...
p.(None): — the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the
p.(None): intended purpose of the device,
p.(None):
p.(None): — where appropriate, the results of biophysical or modelling research whose validity has been demonstrated
p.(None): beforehand.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None): 7.2. The devices must be designed, manufactured and packed in such a way as to minimize the risk posed
p.(None): by contaminants and residues to the persons involved in the transport, storage and use of the devices
p.(None): and to the patients, taking account of the intended purpose of the product. Particular attention must be
p.(None): paid to the tissues exposed and to the duration and frequency of exposure.
p.(None): 7.3. The devices must be designed and manufactured in such a way that they can be used safely
p.(None): with the materials, substances and gases with which they enter into contact during their normal use or during
p.(None): routine procedures; if the devices are intended to administer medicinal products they must be designed and
p.(None): manufactured in such a way as to be compatible with the medicinal products concerned according to the
p.(None): provisions and restrictions governing these products and that their performance is maintained in accordance
p.(None): with the intended use.
p.(None):
p.(None): 7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be
p.(None): considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is
p.(None): liable to act upon the body with action ancillary to that of the device, the quality, safety and
p.(None): usefulness of the substance must be verified by analogy with the methods specified in Annex I to
p.(None): Directive 2001/83/ EC.
p.(None): For the substances referred to in the first paragraph, the notified body shall, having verified the
p.(None): usefulness of the substance as part of the medical device and taking account of the intended purpose of
p.(None): the device, seek a scientific opinion from one of the competent authorities designated by the Member States or
p.(None): the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation
p.(None): (EC) No 726/2004 (1) on the quality and safety of the substance including the clinical benefit/risk profile
p.(None): of the incorporation of the substance into the device. When issuing its opinion, the competent
p.(None): authority or the EMEA shall take into account the manu- facturing process and the data related to the
p.(None): usefulness of incorporation of the substance into the device as determined by the notified body.
p.(None): Where a device incorporates, as an integral part, a human blood deri- vative, the notified body shall,
p.(None): having verified the usefulness of the substance as part of the medical device and taking into account
p.(None): the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through
p.(None): its committee, on the quality and safety of the substance including the clinical benefit/risk profile of
p.(None): the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall
p.(None): take into account the manufac- turing process and the data related to the usefulness of incorporation of the
p.(None): substance into the device as determined by the notified body.
p.(None): Where changes are made to an ancillary substance incorporated in a device, in particular related to its
p.(None): manufacturing process, the notified body shall be informed of the changes and shall consult the relevant
p.(None): medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm
p.(None): that the quality and safety of the ancillary substance are maintained. The competent authority
p.(None): shall take into account the data related to the usefulness of incorporation of the substance into the device
p.(None): as determined by the notified body, in
p.(None):
p.(None): (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying
p.(None): down Community procedures for the authorisation and super- vision of medicinal products for human and
p.(None): veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as
p.(None): last amended by Regu- lation (EC) No 1901/2006.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 27
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): order to ensure that the changes have no negative impact on the estab- lished benefit/risk profile of the
p.(None): addition of the substance in the medical device.
p.(None): When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained
p.(None): information on the ancillary substance, which could have an impact on the established benefit/risk profile
p.(None): of the addition of the substance in the medical device, it shall provide the notified body with advice,
p.(None): whether this information has an impact on the established benefit/risk profile of the addition of the
p.(None): substance in the medical device or not. The notified body shall take the updated scientific opinion
p.(None): into account in reconsidering its assessment of the conformity assessment procedure.
p.(None): 7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the
p.(None): risks posed by substances leaking from the device. Special attention shall be given to substances which
p.(None): are carci- nogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council
p.(None): Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative
p.(None): provisions relating to the classification, packaging and labelling of dangerous substances (1).
p.(None): If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids
p.(None): or other substances to or from the body, or devices intended for transport and storage of such body
p.(None): fluids or substances, contain phthalates which are classified as carci- nogenic, mutagenic or toxic to
p.(None): reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these
p.(None): devices must be labelled on the device itself and/or on the packaging for each unit or, where
p.(None): appropriate, on the sales packaging as a device containing phthalates.
p.(None): If the intended use of such devices includes treatment of children or treatment of pregnant or
...
p.(None): the specified performance.
p.(None): 12.7.3. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the
p.(None): risks arising from the noise emitted, taking account of technical progress and of the means available to
p.(None): reduce noise, particularly at source, unless the noise emitted is part of the specified performance.
p.(None): 12.7.4. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy
p.(None): supplies which the user has to handle must be designed and constructed in such a way as to minimize
p.(None): all possible risks.
p.(None): 12.7.5. Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given
p.(None): temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use.
p.(None): 12.8. Protection against the risks posed to the patient by energy supplies or substances
p.(None): 12.8.1. Devices for supplying the patient with energy or substances must be designed and constructed
p.(None): in such a way that the flow-rate can be set and maintained accurately enough to guarantee the safety of the
p.(None): patient and of the user.
p.(None): 12.8.2. Devices must be fitted with the means of preventing and/or indicating any inadequacies in the
p.(None): flow-rate which could pose a danger.
p.(None): Devices must incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels
p.(None): of energy from an energy and/or substance source.
p.(None): 12.9. The function of the controls and indicators must be clearly specified on the devices.
p.(None): Where a device bears instructions required for its operation or indicates operating or adjustment parameters by
p.(None): means of a visual system, such information must be understandable to the user and, as appropriate, the patient.
p.(None): 13. Information supplied by the manufacturer
p.(None):
p.(None): 13.1. Each device must be accompanied by the information needed to use it safely and properly, taking
p.(None): account of the training and knowledge of the potential users, and to identify the manufacturer.
p.(None):
p.(None): This information comprises the details on the label and the data in the instructions for use.
p.(None): As far as practicable and appropriate, the information needed to use the device safely must be set out on the
p.(None): device itself and/or on the packaging for each unit or, where appropriate, on the sales
p.(None): packaging. If individual packaging of each unit is not practicable, the information must be set out in
p.(None): the leaflet supplied with one or more devices.
p.(None): Instructions for use must be included in the packaging for every device. By way of exception, no such
p.(None): instructions for use are needed for devices in Class I or IIa if they can be used safely without any
p.(None): such instructions.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 31
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
...
p.(None): conform,
p.(None):
p.(None): — where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried
p.(None): out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the
p.(None): type and extent of control applied to the third party;
p.(None): (c) the procedures for monitoring and verifying the design of the products, including the corresponding
p.(None): documentation, and in particular:
p.(None): — a general description of the product, including any variants planned, and its intended use(s),
p.(None): — the design specifications, including the standards which will be applied and the results of the risk
p.(None): analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply
p.(None): to the products if the standards referred to in Article 5 are not applied in full,
p.(None): — the techniques used to control and verify the design and the processes and systematic
p.(None): measures which will be used when the products are being designed,
p.(None): — if the device is to be connected to other device(s) in order to operate as intended, proof must be
p.(None): provided that it conforms to the essential requirements when connected to any such device(s) having the
p.(None): characteristics specified by the manufacturer,
p.(None): — a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood
p.(None): derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection
p.(None): required to assess the safety, quality and usefulness of that substance or human blood derivative, taking
p.(None): account of the intended purpose of the device,
p.(None): — a statement indicating whether or not the device is manufactured utilising tissues of animal origin as
p.(None): referred to in Commission Directive 2003/32/EC (1),
p.(None): — the solutions adopted as referred to in Annex I, Chapter I, Section 2,
p.(None): — the pre-clinical evaluation,
p.(None): — the clinical evaluation referred to in Annex X,
p.(None): — the draft label and, where appropriate, instructions for use.
p.(None):
p.(None): (d) the inspection and quality assurance techniques at the manufacturing stage and in particular:
p.(None): — the processes and procedures which will be used, particularly as regards sterilization, purchasing and
p.(None): the relevant documents,
p.(None): — the product identification procedures drawn up and kept up to date from drawings, specifications or other
p.(None): relevant documents at every stage of manufacture;
p.(None):
p.(None): (1) Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the
p.(None): requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured
p.(None): utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 35
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): — the documentation described in Section 3 needed to assess the conformity of the representative
p.(None): sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of
p.(None): this Directive. The applicant must make a ‘type’ available to the notified body. The notified body may
p.(None): request other samples as necessary,
p.(None): — a written declaration that no application has been lodged with any other notified body for the same type.
p.(None):
p.(None): 3. The documentation must allow an understanding of the design, the manu- facture and the performances
p.(None): of the product and must contain the following items in particular:
p.(None): — a general description of the type, including any variants planned, and its intended use(s),
p.(None): — design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and
p.(None): diagrams of components, sub-assemblies, circuits, etc.,
p.(None): — the descriptions and explanations necessary to understand the above- mentioned drawings and diagrams and
p.(None): the operation of the product,
p.(None): — a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the
p.(None): solutions adopted to meet the essential requirements if the standards referred to in Article 5 have
p.(None): not been applied in full,
p.(None): — the results of the design calculations, risk analysis, investigations, technical tests, etc.
p.(None): carried out,
p.(None): — a statement indicating whether or not the device incorporates, as an integral part, a substance, or
p.(None): human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in
p.(None): this connection which are required to assess the safety, quality and usefulness of that
p.(None): substance, or human blood derivative, taking account of the intended purpose of the device,
p.(None): — a statement indicating whether or not the device is manufactured utilising tissues of animal
p.(None): origin as referred to in Directive 2003/32/EC,
p.(None): — the solutions adopted as referred to in Annex I, Chapter I, Section 2,
p.(None): — the pre-clinical evaluation,
p.(None): — the clinical evaluation referred to in Annex X,
p.(None): — the draft label and, where appropriate, instructions for use.
p.(None):
p.(None): 4. The notified body must:
p.(None): 4.1. examine and assess the documentation and verify that the type has been manufactured in conformity
p.(None): with that documentation; it must also record the items designed in conformity with the applicable
p.(None): provisions of the standards referred to in Article 5, as well as the items not designed on the basis
p.(None): of the relevant provisions of the abovementioned standards;
p.(None): 4.2. carry out or arrange for the appropriate inspections and the tests necessary to verify whether the
p.(None): solutions adopted by the manufacturer meet the essential requirements of this Directive if the standards
p.(None): referred to in Article 5 have not been applied; if the device is to be connected to other device(s) in
p.(None): order to operate as intended, proof must be provided that it
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 39
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None): draw up the statement containing the information stipulated in Section 2.
p.(None): 2. The statement must contain the following information:
p.(None): 2.1. for custom-made devices:
p.(None):
p.(None): — the name and address of the manufacturer,
p.(None):
p.(None): — data allowing identification of the device in question,
p.(None): — a statement that the device is intended for exclusive use by a particular patient, together with the name of
p.(None): the patient,
p.(None): — the name of the medical practitioner or other authorized person who made out the prescription and, where
p.(None): applicable, the name of the clinic concerned,
p.(None):
p.(None): — the specific characteristics of the product as indicated by the prescription,
p.(None):
p.(None): — a statement that the device in question conforms to the essential requirements set out in
p.(None): Annex I and, where applicable, indicating which essential requirements have not been fully met, together
p.(None): with the grounds;
p.(None): 2.2. for devices intended for the clinical investigations covered by Annex X:
p.(None): — data allowing identification of the device in question,
p.(None):
p.(None): — the clinical investigation plan,
p.(None): — the investigator's brochure,
p.(None): — the confirmation of insurance of subjects,
p.(None): — the documents used to obtain informed consent,
p.(None): — a statement indicating whether or not the device incorporates, as an integral part, a substance or
p.(None): human blood derivative referred to in Section 7.4 of Annex I,
p.(None): — a statement indicating whether or not the device is manufactured utilising tissues of animal
p.(None): origin as referred to in Directive 2003/32/EC,
p.(None):
p.(None): — the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
p.(None): — the name of the medical practitioner or other authorized person and of the institution responsible for
p.(None): the investigations,
p.(None): — the place, starting date and scheduled duration for the investigations,
p.(None): — a statement that the device in question conforms to the essential requirements apart from the
p.(None): aspects covered by the investigations and that, with regard to these aspects, every precaution has been
p.(None): taken to protect the health and safety of the patient.
p.(None): 3. The manufacturer must also undertake to keep available for the competent national authorities:
p.(None):
p.(None): 3.1. For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding
p.(None): of the design, manufacture and perfor- mances of the product, including the expected performances, so as
p.(None): to allow assessment of conformity with the requirements of this Directive.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 51
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): The manufacturer must take all the measures necessary to ensure that the manufacturing process produces
p.(None): products which are manufactured in accordance with the documentation mentioned in the first paragraph;
p.(None):
p.(None): 3.2. For devices intended for clinical investigations, the documentation must contain:
p.(None): — a general description of the product and its intended use,
p.(None): — design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and
p.(None): diagrams of components, sub-assemblies, circuits, etc.,
p.(None): — the descriptions and explanations necessary to understand the above- mentioned drawings and diagrams and
p.(None): the operation of the product,
p.(None): — the results of the risk analysis and a list of the standards referred to in Article 5, applied in full
p.(None): or in part, and descriptions of the solutions adopted to meet the essential requirements of this
p.(None): Directive if the standards referred to in Article 5 have not been applied,
p.(None): — if the device incorporates, as an integral part, a substance or human blood derivative referred to in
p.(None): Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to
p.(None): assess the safety, quality and usefulness of that substance or human blood deri- vative, taking account
p.(None): of the intended purpose of the device,
p.(None): — if the device is manufactured utilising tissues of animal origin as referred to in Directive
p.(None): 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of
p.(None): infection,
p.(None): — the results of the design calculations, and of the inspections and technical tests carried
p.(None): out, etc.
p.(None): The manufacturer must take all the measures necessary to ensure that the manufacturing process produces
p.(None): products which are manufactured in accordance with the documentation referred to in the first
p.(None): paragraph of this Section.
p.(None): The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.
p.(None): 4. The information contained in the declarations concerned by this Annex shall be kept for a period
p.(None): of time of at least five years. In the case of implantable devices the period shall be at least 15
p.(None): years.
p.(None): 5. For custom-made devices, the manufacturer must undertake to review and document experience gained
p.(None): in the post-production phase, including the provisions referred to in Annex X, and to implement
p.(None): appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the
p.(None): manufacturer to notify the competent authorities of the following incidents immediately on learning of
p.(None): them and the relevant corrective actions:
...
p.(None): — if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless
p.(None): they are specifically intended for moni- toring of vital physiological parameters, where the nature of variations
p.(None): is such that it could result in immediate danger to the patient, for instance variations in cardiac performance,
p.(None): respiration, activity of CNS in which case they are in Class IIb.
p.(None): Active devices intended to emit ionizing radiation and intended for diag- nostic and therapeutic
p.(None): interventional radiology including devices which control or monitor such devices, or which
p.(None): directly influence their performance, are in Class IIb.
p.(None): Rule 11
p.(None): All active devices intended to administer and/or remove medicines, body liquids or other substances to or from
p.(None): the body are in Class IIa, unless this is done in a manner:
p.(None): — that is potentially hazardous, taking account of the nature of the substances involved, of
p.(None): the part of the body concerned and of the mode of application in which case they are in Class IIb.
p.(None): 3.3. Rule 12
p.(None): All other active devices are in Class I.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 56
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 4. Special Rules
p.(None): 4.1. Rule 13
p.(None): All devices incorporating, as an integral part, a substance which, if used separately, can be considered
p.(None): to be a medicinal product, as defined in Article 1 of Directive ►M5 2001/83/EC ◄, and which is liable
p.(None): to act on the human body with action ancillary to that of the devices, are in Class III.
p.(None):
p.(None): All devices incorporating, as an integral part, a human blood derivative are in Class III.
p.(None):
p.(None): 4.2. Rule 14
p.(None): All devices used for contraception or the prevention of the transmission of sexually transmitted diseases
p.(None): are in Class IIb, unless they are implantable or long term invasive devices, in which case they are in Class
p.(None): III.
p.(None): 4.3. Rule 15
p.(None): All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when
p.(None): appropriate, hydrating contact lenses are in Class IIb.
p.(None): All devices intended specifically to be used for disinfecting medical devices are in Class IIa. ►M5 Unless they
p.(None): are specifically to be used for disin- fecting invasive devices in which case they are in Class IIb. ◄
p.(None): This rule does not apply to products that are intended to clean medical devices other than contact
p.(None): lenses by means of physical action.
p.(None): 4.4. Rule 16
p.(None): ►M5 Devices ◄ specifically intended for recording of X-ray diagnostic images are in Class IIa.
p.(None): 4.5. Rule 17
p.(None): All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III except
p.(None): where such devices are intended to come into contact with intact skin only.
p.(None): 5. Rule 18
p.(None): By derogation from other rules, blood bags are in Class IIb.
p.(None):
p.(None): 1993L0042
...
Searching for indicator usage:
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p.(None): coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae
p.(None): cerebrales, truncus brachio- cephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.
p.(None):
p.(None): 1.8. Central nervous system
p.(None): For the purposes of this Directive, ‘central nervous system’ means brain, meninges and spinal cord.
p.(None):
p.(None): II. IMPLEMENTING RULES
p.(None): 2. Implementing rules
p.(None): 2.1. Application of the classification rules shall be governed by the intended purpose of the devices.
p.(None): 2.2. If the device is intended to be used in combination with another device, the classification rules shall apply
p.(None): separately to each of the devices. Acces- sories are classified in their own right separately from the
p.(None): device with which they are used.
p.(None): 2.3. Software, which drives a device or influences the use of a device, falls automatically in the
p.(None): same class.
p.(None): 2.4. If the device is not intended to be used solely or principally in a specific part of the body,
p.(None): it must be considered and classified on the basis of the most critical specified use.
p.(None): 2.5. If several rules apply to the same device, based on the performance specified for the device
p.(None): by the manufacturer, the strictest rules resulting in the higher classification shall apply.
p.(None):
p.(None): 2.6. In calculating the duration referred to in Section 1.1 of Chapter I, continuous use
p.(None): means ‘an uninterrupted actual use of the device for the intended purpose’. However where usage of a
p.(None): device is discontinued in order for the device to be replaced immediately by the same or an identical device this
p.(None): shall be considered an extension of the continuous use of the device.
p.(None): III. CLASSIFICATION
p.(None):
p.(None): 1. Non-invasive devices
p.(None): 1.1. Rule 1
p.(None): All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies.
p.(None): 1.2. Rule 2
p.(None): All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or
p.(None): gases for the purpose of eventual infusion, administration or introduction into the body are in Class
p.(None): IIa:
p.(None): — if they may be connected to an active medical device in Class IIa or a higher class,
p.(None): — if they are intended for use for storing or channelling blood or other body liquids or for storing
p.(None): organs, parts of organs or body tissues,
p.(None): in all other cases they are in Class I.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 54
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): 1.3. Rule 3
...
Health / HIV/AIDS
Searching for indicator HIV:
(return to top)
p.(None): which explicit prior authorization with regard to conformity is required for them to be placed on the
p.(None): market;
p.(None): Whereas in cases where the conformity of the devices can be assessed under the responsibility of the
p.(None): manufacturer the competent authorities must be able, particularly in emergencies, to contact a
p.(None): person responsible for placing the device on the market and established in the Community, whether the
p.(None): manufacturer or another person established in the Community and designated by the manufacturer for the purpose;
p.(None): Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of
p.(None): this Directive to enable
p.(None):
p.(None): (1) OJ No L 109, 26.4.1983, p. 8. Directive as last amended by Commission Decision 92/400/EEC (OJ No L
p.(None): 221, 6.8.1992, p. 55).
p.(None): (2) OJ No L 197, 18.7.1987, p. 33.
p.(None): (3) OJ No L 147, 9.6.1975, p. 1. Directive as last amended by Directive 91/507/ EEC (OJ No L 270, 26.9.1991, p.
p.(None): 32).
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 5
p.(None):
p.(None): ▼B
p.(None): them to move freely within the Community and to be put into service in accordance with their intended purpose;
p.(None): Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16
p.(None): May 1989 regarding future activities on AIDS prevention and control at Community level (1), medical
p.(None): devices used for protection against the HIV virus must afford a high level of protection; whereas the
p.(None): design and manufacture of such products should be verified by a notified body;
p.(None): Whereas the classification rules generally enable medical devices to be appropriately classified; whereas,
p.(None): in view of the diverse nature of the devices and technological progress in this field, steps must be
p.(None): taken to include amongst the implementing powers conferred on the Commission the decisions to be taken with
p.(None): regard to the proper classification or reclassification of the devices or, where appropriate, the
p.(None): adjustment of the classification rules themselves; whereas since these issues are closely connected
p.(None): with the protection of health, it is appropriate that these decisions should come under procedure IIIa,
p.(None): as provided for in Directive 87/373/EEC;
p.(None): Whereas the confirmation of complicance with the essential requirements may mean that clinical
p.(None): investigations have to be carried out under the responsibility of the manufacturer; whereas, for
p.(None): the purpose of carrying out the clinical investigations, appropriate means have to be specified for the
p.(None): protection of public health and public order;
p.(None): Whereas the protection of health and the associated controls may be made more effective by means of
p.(None): medical device vigilance systems which are integrated at Community level;
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): ANNEX I
p.(None):
p.(None): ESSENTIAL REQUIREMENTS
p.(None):
p.(None): I. GENERAL REQUIREMENTS
p.(None):
p.(None): 1. The devices must be designed and manufactured in such a way that, when used under the
p.(None): conditions and for the purposes intended, they will not compromise the clinical condition or the safety of
p.(None): patients, or the safety and health of users or, where applicable, other persons, provided that any risks
p.(None): which may be associated with their intended use constitute acceptable risks when weighed against the benefits to
p.(None): the patient and are compatible with a high level of protection of health and safety.
p.(None): This shall include:
p.(None): — reducing, as far as possible, the risk of use error due to the ergonomic features of the device
p.(None): and the environment in which the device is intended to be used (design for patient safety), and
p.(None): — consideration of the technical knowledge, experience, education and training and where applicable the medical
p.(None): and physical conditions of intended users (design for lay, professional, disabled or other users).
p.(None):
p.(None): 2. The solutions adopted by the manufacturer for the design and construction of the
p.(None): devices must conform to safety principles, taking account of the generally acknowledged state of the art.
p.(None): In selecting the most appropriate solutions, the manufacturer must apply the following principles in the
p.(None): following order:
p.(None): — eliminate or reduce risks as far as possible (inherently safe design and construction),
p.(None): — where appropriate take adequate protection measures including alarms if necessary, in relation to
p.(None): risks that cannot be eliminated,
p.(None): — inform users of the residual risks due to any shortcomings of the protection measures adopted.
p.(None): 3. The devices must achieve the performances intended by the manu- facturer and be designed,
p.(None): manufactured and packaged in such a way that they are suitable for one or more of the functions
p.(None): referred to in Article 1 (2) (a), as specified by the manufacturer.
p.(None): 4. The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely
p.(None): affected to such a degree that the clinical conditions and safety of the patients and, where applicable,
p.(None): of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device
p.(None): is subjected to the stresses which can occur during normal conditions of use.
p.(None): 5. The devices must be designed, manufactured and packed in such a way that their characteristics and
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): marking. They shall be accompanied by the information referred to in point 13 of Annex I which
p.(None): includes, where appropriate, the information supplied by the manufacturers of the devices which
p.(None): have been put together. ►M5 The declarations referred to in paragraphs 2 and 3 shall be kept
p.(None): at the disposal of the competent authorities for a period of five years. ◄
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): Article 12a
p.(None): Reprocessing of medical devices
p.(None):
p.(None): The Commission shall, no later than 5 September 2010, submit a report to the European Parliament and to the
p.(None): Council on the issue of the reprocessing of medical devices in the Community.
p.(None):
p.(None): In the light of the findings of this report, the Commission shall submit to the European Parliament and to
p.(None): the Council any additional proposal it may deem appropriate in order to ensure a high level of
p.(None): health protection.
p.(None):
p.(None):
p.(None): Article 13
p.(None): Decisions with regard to classification and derogation clause
p.(None):
p.(None): 1. A Member State shall submit a duly substantiated request to the Commission and ask it to take the
p.(None): necessary measures in the following situations:
p.(None):
p.(None): (a) that Member State considers that the application of the classification rules set out in Annex IX requires a
p.(None): decision with regard to the classification of a given device or category of devices;
p.(None):
p.(None): (b) that Member State considers that a given device or family of devices should, by way of
p.(None): derogation from the provisions of Annex IX, be classified in another class;
p.(None):
p.(None): (c) that Member State considers that the conformity of a device or family of devices should, by way of
p.(None): derogation from Article 11, be established by applying solely one of the given procedures chosen from
p.(None): among those referred to in Article 11;
p.(None):
p.(None): (d) that Member State considers that a decision is required as to whether a particular product
p.(None): or product group falls within one of the definitions in Article 1(2)(a) to (e).
p.(None):
p.(None): The measures referred to in the first subparagraph of this paragraph shall, as appropriate, be adopted
p.(None): in accordance with the procedure referred to in Article 7(2).
p.(None):
p.(None): 2. The Commission shall inform the Member States of the measures taken.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 17
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): ▼M1
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): Article 14
p.(None): Registration of persons responsible for placing devices on the market
p.(None):
p.(None): 1. Any manufacturer who, under his own name, places devices on the market in accordance with the
p.(None): procedures referred to in Article 11
...
p.(None): shall take account of the results of any assessment and verification operations which, where appropriate,
p.(None): have been carried out in accordance with this Directive at an intermediate stage of manufacture.
p.(None): 6. Where the conformity assessment procedure involves the inter- vention of a notified body, the manufacturer, or
p.(None): his authorized repre- sentative established in the Community, may apply to a body of his choice within the framework
p.(None): of the tasks for which the body has been notified.
p.(None): 7. The notified body may require, where duly justified, any infor- mation or data which is necessary for
p.(None): establishing and maintaining the attestation of conformity in view of the chosen procedure.
p.(None): 8. Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for
p.(None): a maximum of five years and may be extended on application, made at a time agreed in the contract
p.(None): signed by both parties, for further periods of five years.
p.(None): 9. By derogation from paragraphs 1 and 2 the competent autho- rities may authorize, on duly
p.(None): justified request, the placing on the market and putting into service, within the territory of the
p.(None): Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 and 2
p.(None): have not been carried out and the use of which is in the interest of protection of health.’;
p.(None): 3. the following Article 9a is inserted after Article 9:
p.(None):
p.(None): ‘Article 9a
p.(None): 1. Where a Member State considers that the conformity of a device or family of devices should be
p.(None): established, by way of dero- gation from the provisions of Article 9, by applying solely one of the
p.(None): given procedures chosen from among those referred to in Article 9, it shall submit a duly substantiated request to the
p.(None): Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with
p.(None): the procedure referred to in Article 7
p.(None): (2) of Directive 93/42/EEC (*).
p.(None): 2. The Commission shall inform the Member States of the measures taken and, where appropriate,
p.(None): publish the relevant parts of these measures in the Official Journal of the European Commu- nities.
p.(None):
p.(None): (*) OJ No L 169, 12.7.1993, p. 1.’
p.(None):
p.(None): 4. Article 10 shall be amended as follows:
p.(None): — the following subparagraph shall be added to paragraph 2:
p.(None): ‘Member States may however authorize manufacturers to start the clinical investigations in question before the
p.(None): expiry of the 60- day period, provided that the Ethical Committee concerned has delivered a favourable
p.(None): opinion with respect to the investigation programme in question.’,
p.(None): — the following paragraph shall be inserted:
p.(None): ‘2a. The authorization referred to in the second subparagraph of paragraph 2 may be subject to
p.(None): approval by the competent authority.’;
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 24
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): — to be totally introduced into the human body or,
p.(None): — to replace an epithelial surface or the surface of the eye,
p.(None): by surgical intervention which is intended to remain in place after the procedure.
p.(None): Any device intended to be partially introduced into the human body through surgical intervention
p.(None): and intended to remain in place after the procedure for at least 30 days is also considered an
p.(None): implantable device.
p.(None): 1.3. Reusable surgical instrument
p.(None): Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting,
p.(None): clipping or similar procedures, without connection to any active medical device and which can be
p.(None): reused after appropriate procedures have been carried out.
p.(None): 1.4. Active medical device
p.(None): Any medical device operation of which depends on a source of electrical energy or any source of power
p.(None): other than that directly generated by the human body or gravity and which acts by converting this energy.
p.(None): Medical devices intended to transmit energy, substances or other elements between an active medical device
p.(None): and the patient, without any significant change, are not considered to be active medical devices. ►M5
p.(None): Stand alone software is considered to be an active medical device. ◄
p.(None): 1.5. Active therapeutical device
p.(None): Any active medical device, whether used alone or in combination with other medical devices, to support,
p.(None): modify, replace or restore biological functions or structures with a view to treatment or
p.(None): alleviation of an illness, injury or handicap.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 53
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 1.6. Active device for diagnosis
p.(None): Any active medical device, whether used alone or in combination with other medical devices, to supply
p.(None): information for detecting, diagnosing, monitoring or treating physiological conditions, states of health,
p.(None): illnesses or congenital deformities.
p.(None):
p.(None): 1.7. Central circulatory system
p.(None): For the purposes of this Directive, ‘central circulatory system’ means the following vessels:
p.(None): arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae
p.(None): coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae
p.(None): cerebrales, truncus brachio- cephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.
p.(None):
p.(None): 1.8. Central nervous system
p.(None): For the purposes of this Directive, ‘central nervous system’ means brain, meninges and spinal cord.
p.(None):
p.(None): II. IMPLEMENTING RULES
p.(None): 2. Implementing rules
p.(None): 2.1. Application of the classification rules shall be governed by the intended purpose of the devices.
...
Health / Pregnant
Searching for indicator pregnant:
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p.(None): substance in the medical device or not. The notified body shall take the updated scientific opinion
p.(None): into account in reconsidering its assessment of the conformity assessment procedure.
p.(None): 7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the
p.(None): risks posed by substances leaking from the device. Special attention shall be given to substances which
p.(None): are carci- nogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council
p.(None): Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative
p.(None): provisions relating to the classification, packaging and labelling of dangerous substances (1).
p.(None): If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids
p.(None): or other substances to or from the body, or devices intended for transport and storage of such body
p.(None): fluids or substances, contain phthalates which are classified as carci- nogenic, mutagenic or toxic to
p.(None): reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these
p.(None): devices must be labelled on the device itself and/or on the packaging for each unit or, where
p.(None): appropriate, on the sales packaging as a device containing phthalates.
p.(None): If the intended use of such devices includes treatment of children or treatment of pregnant or
p.(None): nursing women, the manufacturer must provide a specific justification for the use of these substances
p.(None): with regard to compliance with the essential requirements, in particular of this paragraph, within the
p.(None): technical documentation and, within the instructions for use, information on residual risks for these
p.(None): patient groups and, if applicable, on appropriate precautionary measures.
p.(None):
p.(None): 7.6. Devices must be designed and manufactured in such a way as to reduce, as much as possible,
p.(None): risks posed by the unintentional ingress of substances into the device taking into account the device
p.(None): and the nature of the environment in which it is intended to be used.
p.(None): 8. Infection and microbial contamination
p.(None): 8.1. The devices and manufacturing processes must be designed in such a way as to eliminate or
p.(None): reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy
p.(None): handling and, where necessary, minimize contamination of the device by the patient or vice versa during
p.(None): use.
p.(None): 8.2. Tissues of animal origin must originate from animals that have been subjected to veterinary
p.(None): controls and surveillance adapted to the intended use of the tissues.
p.(None): Notified bodies shall retain information on the geographical origin of the animals.
p.(None): Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be
...
Health / injured
Searching for indicator injured:
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p.(None): All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or
p.(None): gases for the purpose of eventual infusion, administration or introduction into the body are in Class
p.(None): IIa:
p.(None): — if they may be connected to an active medical device in Class IIa or a higher class,
p.(None): — if they are intended for use for storing or channelling blood or other body liquids or for storing
p.(None): organs, parts of organs or body tissues,
p.(None): in all other cases they are in Class I.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 54
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): 1.3. Rule 3
p.(None): All non-invasive devices intended for modifying the biological or chemical composition of blood, other body
p.(None): liquids or other liquids intended for infusion into the body are in Class IIb, unless the treatment
p.(None): consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa.
p.(None): 1.4. Rule 4
p.(None): All non-invasive devices which come into contact with injured skin:
p.(None): — are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of
p.(None): exudates,
p.(None): — are in Class IIb if they are intended to be used principally with wounds which have breached the dermis and can only
p.(None): heal by secondary intent,
p.(None): — are in Class IIa in all other cases, including devices principally intended to manage the micro-environment of
p.(None): a wound.
p.(None): 2. Invasive devices
p.(None): 2.1. Rule 5
p.(None): ►M5 All invasive devices with respect to body orifices, other than surgically invasive devices
p.(None): and which are not intended for connection to an active medical device or which are intended for connection to an
p.(None): active medical device in Class I: ◄
p.(None): — are in Class I if they are intended for transient use,
p.(None): — are in Class IIa if they are intended for short-term use, except if they are used in the oral
p.(None): cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which
p.(None): case they are in Class I,
p.(None): — are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as
p.(None): the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be
p.(None): absorbed by the mucous membrane, in which case they are in Class IIa.
p.(None): All invasive devices with respect to body orifices, other than surgically invasive devices, intended for
p.(None): connection to an active medical device in Class IIa or a higher class, are in Class IIa.
p.(None):
p.(None): 2.2. Rule 6
p.(None): All surgically invasive devices intended for transient use are in Class IIa unless they are:
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.(None): concerned; whereas the details added to these modules are justified by the nature of the verifi- cation
p.(None): required for medical devices;
p.(None): Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group
p.(None): the devices into four product classes; whereas the classification rules are based on the vulnerability of
p.(None): the human body taking account of the potential risks associated with the technical design and
p.(None): manufacture of the devices; whereas the conformity assessment procedures for Class I devices can
p.(None): be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of
p.(None): vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified
p.(None): body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and
p.(None): III which constitute a high risk potential, inspection by a notified body is required with regard
p.(None): to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for
p.(None): which explicit prior authorization with regard to conformity is required for them to be placed on the
p.(None): market;
p.(None): Whereas in cases where the conformity of the devices can be assessed under the responsibility of the
p.(None): manufacturer the competent authorities must be able, particularly in emergencies, to contact a
p.(None): person responsible for placing the device on the market and established in the Community, whether the
p.(None): manufacturer or another person established in the Community and designated by the manufacturer for the purpose;
p.(None): Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of
p.(None): this Directive to enable
p.(None):
p.(None): (1) OJ No L 109, 26.4.1983, p. 8. Directive as last amended by Commission Decision 92/400/EEC (OJ No L
p.(None): 221, 6.8.1992, p. 55).
p.(None): (2) OJ No L 197, 18.7.1987, p. 33.
p.(None): (3) OJ No L 147, 9.6.1975, p. 1. Directive as last amended by Directive 91/507/ EEC (OJ No L 270, 26.9.1991, p.
p.(None): 32).
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 5
p.(None):
p.(None): ▼B
p.(None): them to move freely within the Community and to be put into service in accordance with their intended purpose;
p.(None): Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16
p.(None): May 1989 regarding future activities on AIDS prevention and control at Community level (1), medical
p.(None): devices used for protection against the HIV virus must afford a high level of protection; whereas the
p.(None): design and manufacture of such products should be verified by a notified body;
p.(None): Whereas the classification rules generally enable medical devices to be appropriately classified; whereas,
p.(None): in view of the diverse nature of the devices and technological progress in this field, steps must be
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): secure sterility.
p.(None): 3.3. The notified body audits the quality system to determine whether it meets the requirements referred
p.(None): to in section 3.2. It must presume that quality systems which implement the relevant harmonized
p.(None): standards conform to these requirements.
p.(None): The assessment team must include at least one member with past experience of assessments of the
p.(None): technology concerned. The assessment procedure must include an inspection on the manufacturer's premises
p.(None): and, in duly substantiated cases, on the premises of the manufacturer's suppliers to inspect the manufacturing
p.(None): processes.
p.(None): The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and
p.(None): a reasoned assessment.
p.(None): 3.4. The manufacturer must inform the notified body which approved the quality system of any
p.(None): plan for substantial changes to the quality system.
p.(None): The notified body must assess the changes proposed and verify whether after these changes the quality
p.(None): system will still meet the requirements referred to in Section 3.2.
p.(None): After receiving the abovementioned information it must notify the manu- facturer of its decision. This
p.(None): decision must contain the conclusions of the inspection and a reasoned assessment.
p.(None): 4. Surveillance
p.(None): 4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by
p.(None): the approved quality system.
p.(None): 4.2. The manufacturer must allow the notified body access for inspection purposes to the
p.(None): inspection, testing and storage locations and supply it with all relevant information, in particular:
p.(None): — the documentation on the quality system,
p.(None): — the technical documentation,
p.(None): — the quality records, such as inspection reports, test data, calibration data, qualification reports of
p.(None): the staff concerned, etc.
p.(None): 4.3. The notified body must periodically carry out appropriate inspections and assessments to make sure
p.(None): that the manufacturer applies the quality system and must supply the manufacturer with an assessment
p.(None): report.
p.(None): 4.4. In addition, the notified body may pay unannounced visits to the manu- facturer. At the time of such
p.(None): visits, the notified body may, where necessary,
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 47
p.(None):
p.(None): ▼B
p.(None): carry out or ask for tests in order to check that the quality system is working properly and that the
p.(None): production conforms to the requirements of the Directive which apply to it. To this end, an adequate
p.(None): sample of the final products, taken on site by the notified body, must be examined and the appropriate
p.(None): tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out.
p.(None): Where one or more of the samples fails to conform, the notified body must take the appropriate measures.
p.(None): It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test
p.(None): report.
p.(None): 5. Administrative provisions
p.(None): 5.1. ►M5 The manufacturer or his authorised representative must, for a period ending at least five years, and in the
...
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): of human subjects are carried out in the spirit of the Helsinki Declaration. This includes
p.(None): every step in the clinical investigation from first consideration of the need and justification of the study to
p.(None): publication of the results.
p.(None): 2.3. Methods
p.(None): 2.3.1. Clinical investigations must be performed on the basis of an appropriate plan of investigation
p.(None): reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute
p.(None): the manu- facturer's claims for the device; these investigations must include an adequate number of
p.(None): observations to guarantee the scientific validity of the conclusions.
p.(None): 2.3.2. The procedures used to perform the investigations must be appropriate to the device under examination.
p.(None): 2.3.3. Clinical investigations must be performed in circumstances similar to the normal conditions of use of
p.(None): the device.
p.(None): 2.3.4. All the appropriate features, including those involving the safety and performances of the device,
p.(None): and its effect on patients must be examined.
p.(None):
p.(None): 2.3.5. All serious adverse events must be fully recorded and immediately notified to all competent
p.(None): authorities of the Member States in which the clinical investigation is being performed.
p.(None):
p.(None): 2.3.6. The investigations must be performed under the responsibility of a medical practitioner or
p.(None): another authorized qualified person in an appro- priate environment.
p.(None): The medical practitioner or other authorized person must have access to the technical and clinical data
p.(None): regarding the device.
p.(None): 2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must
p.(None): contain a critical evaluation of all the data collected during the clinical investigation.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 59
p.(None):
p.(None): ▼B
p.(None): ANNEX XI
p.(None):
p.(None): CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES
p.(None):
p.(None): 1. The notified body, its Director and the assessment and verification staff shall not be the designer,
p.(None): manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative
p.(None): of any of these persons. They may not be directly involved in the design, construction, marketing or
p.(None): maintenance of the devices, nor represent the parties engaged in these activities. This in no
p.(None): way precludes the possibility of exchanges of technical information between the manufacturer and
p.(None): the body.
p.(None): 2. The notified body and its staff must carry out the assessment and verification operations with the highest
p.(None): degree of professional integrity and the requisite competence in the field of medical devices and
p.(None): must be free from all pressures and inducements, particularly financial, which might influence
p.(None): their judgment or the results of the inspection, especially from persons or groups of persons with an
p.(None): interest in the results of the verifications.
p.(None): Should the notified body subcontract specific tasks connected with the estab- lishment and verification of the
p.(None): facts, it must first ensure that the subcon- tractor meets the provisions of the Directive and, in particular,
p.(None): of this Annex. The notified body shall keep at the disposal of the national authorities the relevant
p.(None): documents assessing the subcontractor's qualifications and the work carried out by the subcontractor under
p.(None): this Directive.
p.(None): 3. The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes
p.(None): II to VI and for which it has been notified, whether these tasks are carried out by the body itself or on
p.(None): its responsibility. In particular, it must have the necessary staff and possess the facilities needed to
p.(None): perform properly the technical and administrative tasks entailed in assessment and verification.
p.(None): ►M1 This presupposes the availability of sufficient scientific staff within the organisation who
p.(None): possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which
p.(None): it has been notified, having regard to the requirements of this Directive and, in particular, those set out in
p.(None): Annex I. ◄ It must also have access to the equipment necessary for the verifications required.
p.(None): 4. The notified body must have:
p.(None): — sound vocational training covering all the assessment and verification operations for which the body
p.(None): has been designated,
p.(None): — satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of
p.(None): such inspections,
p.(None): — the ability required to draw up the certificates, records and reports to demonstrate that the
p.(None): inspections have been carried out.
p.(None): 5. The impartiality of the notified body must be guaranteed. Their remuneration must not depend on the number of
p.(None): inspections carried out, nor on the results of the inspections.
p.(None): 6. The body must take out civil liability insurance, unless liability is assumed by the State under domestic
p.(None): legislation or the Member State itself carries out the inspections directly.
p.(None): 7. The staff of the notified body are bound to observe professional secrecy with regard to all information gained in
p.(None): the course of their duties (except vis-à-vis the competent administrative authorities of the State in which
p.(None): their activities are carried out) pursuant to this Directive or any provision of national law putting it
p.(None): into effect.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 60
p.(None):
p.(None): ▼B
p.(None): ANNEX XII
p.(None):
p.(None): CE MARKING OF CONFORMITY
p.(None):
p.(None): The CE conformity marking shall consist of the initials ‘CE’ taking the following form:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Social / Child
Searching for indicator children:
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p.(None): substance in the medical device or not. The notified body shall take the updated scientific opinion
p.(None): into account in reconsidering its assessment of the conformity assessment procedure.
p.(None): 7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the
p.(None): risks posed by substances leaking from the device. Special attention shall be given to substances which
p.(None): are carci- nogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council
p.(None): Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative
p.(None): provisions relating to the classification, packaging and labelling of dangerous substances (1).
p.(None): If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids
p.(None): or other substances to or from the body, or devices intended for transport and storage of such body
p.(None): fluids or substances, contain phthalates which are classified as carci- nogenic, mutagenic or toxic to
p.(None): reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these
p.(None): devices must be labelled on the device itself and/or on the packaging for each unit or, where
p.(None): appropriate, on the sales packaging as a device containing phthalates.
p.(None): If the intended use of such devices includes treatment of children or treatment of pregnant or
p.(None): nursing women, the manufacturer must provide a specific justification for the use of these substances
p.(None): with regard to compliance with the essential requirements, in particular of this paragraph, within the
p.(None): technical documentation and, within the instructions for use, information on residual risks for these
p.(None): patient groups and, if applicable, on appropriate precautionary measures.
p.(None):
p.(None): 7.6. Devices must be designed and manufactured in such a way as to reduce, as much as possible,
p.(None): risks posed by the unintentional ingress of substances into the device taking into account the device
p.(None): and the nature of the environment in which it is intended to be used.
p.(None): 8. Infection and microbial contamination
p.(None): 8.1. The devices and manufacturing processes must be designed in such a way as to eliminate or
p.(None): reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy
p.(None): handling and, where necessary, minimize contamination of the device by the patient or vice versa during
p.(None): use.
p.(None): 8.2. Tissues of animal origin must originate from animals that have been subjected to veterinary
p.(None): controls and surveillance adapted to the intended use of the tissues.
p.(None): Notified bodies shall retain information on the geographical origin of the animals.
p.(None): Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be
...
Social / Incarcerated
Searching for indicator restricted:
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p.(None):
p.(None): 3. The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in
p.(None): particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in
p.(None): Article 7(2).
p.(None): 4. The provisions of this Article shall be implemented no later than
p.(None): 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational
p.(None): functioning and the added value of the
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 18
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to
p.(None): the European Parliament and the Council or present draft measures in accordance with paragraph 3.
p.(None):
p.(None): Article 14b
p.(None): Particular health monitoring measures
p.(None):
p.(None): Where a Member State considers, in relation to a given product or group of products, that, in order to
p.(None): ensure protection of health and safety and/or to ensure that public health requirements are observed,
p.(None): such products should be withdrawn from the market, or their placing on the market and putting into service
p.(None): should be prohibited, restricted or subjected to particular requirements, it may take any necessary and
p.(None): justified transitional measures.
p.(None): The Member State shall then inform the Commission and all other Member States, giving the reasons for
p.(None): its decision.
p.(None): The Commission shall, whenever possible, consult the interested Parties and the Member States.
p.(None): The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The
p.(None): Commission shall inform all the Member States and the consulted interested Parties thereof.
p.(None): When appropriate, the necessary measures designed to amend non- essential elements of this Directive,
p.(None): relating to withdrawal from the market, prohibition of placing on the market and putting into service of
p.(None): a certain product or group of products or to restrictions or intro- duction of particular requirements
p.(None): in order for such products to be put on the market, shall be adopted in accordance with the regulatory
p.(None): procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the
p.(None): Commission may use the urgency procedure referred to in Article 7(4).
p.(None): Article 15
p.(None): Clinical investigation
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): 1. In the case of devices intended for clinical investigations, the manufacturer or the authorised
p.(None): representative, established in the Community, shall follow the procedure referred to in Annex VIII and
p.(None): notify the competent authorities of the Member States in which the investigations are to be conducted
...
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p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 10
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): that they have been the subject of an assessment of their conformity in accordance with the provisions of
p.(None): Article 11.
p.(None): 2. Member States shall not create any obstacle to:
p.(None): — devices intended for clinical investigation being made available to medical practitioners or authorized
p.(None): persons for that purpose if they meet the conditions laid down in Article 15 and in Annex VIII,
p.(None):
p.(None): — custom-made devices being placed on the market and put into service if they meet the conditions
p.(None): laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be
p.(None): accompanied by the statement referred to in Annex VIII, which shall be available to the particular
p.(None): patient identified by name, an acronym or a numerical code.
p.(None):
p.(None): These devices shall not bear the CE marking.
p.(None): 3. At trade fairs, exhibitions, demonstrations, etc. Member States shall not create any obstacle to
p.(None): the showing of devices which do not conform to this Directive, provided that a visible sign clearly
p.(None): indicates that such devices cannot be marketed or put into service until they have been made to comply.
p.(None): 4. Member States may require the information, which must be made available to the user and the patient
p.(None): in accordance with Annex I, point 13, to be in their national language(s) or in another
p.(None): Community language, when a device reaches the final user, regardless of whether it is for professional or
p.(None): other use.
p.(None): 5. Where the devices are subject to other Directives concerning other aspects and which also provide for the
p.(None): affixing of the CE marking, the latter shall indicate that the devices also fulfil the provisions of the other
p.(None): Directives.
p.(None): However, should one or more of these directives allow the manu- facturer, during a transitional period,
p.(None): to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil
p.(None): the provisions only of those directives applied by the manufacturer. In this case, the particulars of
p.(None): these directives, as published in the Official Journal of the European Communities, must be given
p.(None): in the documents, notices or instructions required by the directives and accom- panying such devices.
p.(None):
p.(None):
p.(None): Article 5
p.(None): Reference to standards
p.(None):
p.(None): 1. Member States shall presume compliance with the essential requirements referred to in Article
p.(None): 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant
p.(None): to the harmonized standards the references of which have been publishes in the Official Journal of the
p.(None): European Communities; Member States shall publish the references of such national standards.
p.(None): 2. For the purposes of this Directive, reference to harmonized standards also includes the
p.(None): monographs of the European Pharma- copoeia notably on surgical sutures and on interaction
...
p.(None): 8. The manufacturer may instruct his authorized representative
p.(None): ►M5 ◄ to initiate the procedures provided for in
p.(None): Annexes III, IV, VII and VIII.
p.(None): 9. Where the conformity assessment procedure involves the inter- vention of a notified body, the
p.(None): manufacturer, or his authorized repre-
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 15
p.(None):
p.(None):
p.(None): ▼B
p.(None): sentative ►M5
p.(None):
p.(None):
p.(None): ◄, may apply to a body of his choice
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None): within the framework of the tasks for which the body has been notified.
p.(None): 10. The notified body may require, where duly justified, any infor- mation or data, which is necessary
p.(None): for establishing and maintaining the attestation of conformity in view of the chosen procedure.
p.(None): 11. Decisions taken by the notified bodies in accordance with
p.(None): ►M5 Annexes II, III, V and VI ◄ shall be valid for a maximum of five years and may be extended on
p.(None): application, made at a time agreed in the contract signed by both parties, ►M5 for further periods of a
p.(None): maximum length of five years ◄.
p.(None): 12. The records and correspondence relating to the procedures referred to in paragraphs 1 to 6
p.(None): shall be in an official language of the Member State in which the procedures are carried out and/or in another
p.(None): Community language acceptable to the notified body.
p.(None): 13. By derogation from paragraphs 1 to 6, the competent authorities may authorize, on duly justified
p.(None): request, the placing on the market and putting into service, within the territory of the Member State concerned, of
p.(None): individual devices for which the procedures referred to in paragraphs 1 to 6 have not been carried out and the use of
p.(None): which is in the interest of protection of health.
p.(None):
p.(None): 14. The measures designed to amend non-essential elements of this Directive, by supplementing it,
p.(None): relating to the means by which, in the light of technical progress and considering the intended users
p.(None): of the devices concerned, the information laid down in Annex I Section 13.1 may be set
p.(None): out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article
p.(None): 7(3).
p.(None):
p.(None): Article 12
p.(None): ►M5 Particular procedure for systems and procedure packs and procedure for sterilisation ◄
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None): 1. By way of derogation from Article 11 this Article shall apply to systems and procedure packs.
p.(None): 2. Any natural or legal person who puts devices bearing the CE marking together within their
p.(None): intended purpose and within the limits of use specified by their manufacturers, in order to place them
...
Social / Marital Status
Searching for indicator single:
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p.(None): Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to
p.(None): manage the funding of public health and sickness insurance schemes relating directly or indirectly
p.(None): to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to
p.(None): implement the abovemen- tioned measures provided Community law is complied with;
p.(None): Whereas medical devices should provide patients, users and third parties with a high level of protection
p.(None): and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the
p.(None): main- tenance or improvement of the level of protection attained in the Member States is one of
p.(None): the essential objectives of this Directive;
p.(None): Whereas certain medical devices are intended to administer medicinal products within the meaning of
p.(None): Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law,
p.(None): regulation or administrative action relating to proprietary medicinal products (4); whereas, in such
p.(None): cases, the placing on the market of the medical device as a general rule is governed by the present
p.(None): Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC;
p.(None): whereas if, however, such a device is placed on the market in such a way that the device and the medicinal
p.(None): product form a single integral unit which is intended exclusively for use in the given combination and which is not
p.(None): reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn
p.(None): between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately,
p.(None): may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such
p.(None): cases, if the substances incorporated in the medical devices are liable to act upon the body with
p.(None): action ancillary to that of the device, the placing of the devices on the market is governed by
p.(None):
p.(None): (1) OJ No C 237, 12.9.1991 and OJ No C 251, 28.9.1992, p. 40.
p.(None): (2) OJ No C 150, 31.5.1993 and OJ No C 176, 28.6.1993.
p.(None): (3) OJ No C 79, 30.3.1992, p. 1.
p.(None): (4) OJ No 22, 9.6.1965, p. 369/65. Directive as last amended by Directive 92/27/ EEC (OJ No L 113, 30.4.1992, p.
p.(None): 8).
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 3
p.(None):
p.(None): ▼B
p.(None): this Directive; whereas, in this context, the safety, quality and usefulness of the substances
p.(None): must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20
p.(None): May 1975 on the approximation of the laws of the Member States relating to analytical,
p.(None): pharmaco-toxicological and clinical standards and protocols in respect of the testing of
p.(None): proprietary medicinal products (1);
p.(None): Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any
...
p.(None): and/or use on the Community market, regardless of whether it is new or fully refurbished;
p.(None):
p.(None): (i) ‘putting into service’ means the stage at which a device has been made available to the final
p.(None): user as being ready for use on the Community market for the first time for its intended purpose;
p.(None): (j) ‘authorised representative’ means any natural or legal person estab- lished in the Community who,
p.(None): explicitly designated by the manu- facturer, acts and may be addressed by authorities and bodies in the Community
p.(None): instead of the manufacturer with regard to the latter's obligations under this Directive;
p.(None):
p.(None): (k) ‘clinical data’ means the safety and/or performance information that is generated from the use of a
p.(None): device. Clinical data are sourced from:
p.(None): — clinical investigation(s) of the device concerned; or
p.(None): — clinical investigation(s) or other studies reported in the scientific literature, of a similar
p.(None): device for which equivalence to the device in question can be demonstrated; or
p.(None): — published and/or unpublished reports on other clinical experience of either the device in
p.(None): question or a similar device for which equivalence to the device in question can be demon- strated;
p.(None): (l) ‘device subcategory’ means a set of devices having common areas of intended use or common
p.(None): technology;
p.(None): (m) ‘generic device group’ means a set of devices having the same or similar intended uses or commonality
p.(None): of technology allowing them to be classified in a generic manner not reflecting specific charac- teristics;
p.(None): (n) ‘single use device’ means a device intended to be used once only for a single patient.
p.(None): 3. Where a device is intended to administer a medicinal product within the meaning of Article 1
p.(None): of Directive 2001/83/EC (1), that
p.(None):
p.(None): (1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.(None): Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). Directive as
p.(None): last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 8
p.(None):
p.(None): ▼M5
p.(None): device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC
p.(None): with regard to the medicinal product.
p.(None):
p.(None): If, however, such a device is placed on the market in such a way that the device and the medicinal
p.(None): product form a single integral product which is intended exclusively for use in the given combination
p.(None): and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The
p.(None): relevant essential requirements of Annex I to this Directive shall apply as far as safety and
p.(None): performance-related device features are concerned.
p.(None):
p.(None): ▼B
p.(None): 4. Where a device incorporates, as an integral part, a substance which, if used separately, may be
p.(None): considered to be a medicinal product within the meaning of Article 1 of Directive ►M5 2001/83/EC ◄ and
p.(None): which is liable to act upon the body with action ancillary to that of the device, ►M5 that device shall ◄ be
p.(None): assessed and authorized in accordance with this Directive.
p.(None):
p.(None):
p.(None): ▼M2
p.(None):
p.(None): 4 a. Where a device incorporates, as an integral part, a substance which, if used separately,
p.(None): may be considered to be a medicinal product constituent or a medicinal product derived from human
p.(None): blood or human plasma within the meaning of Article 1 of Directive
p.(None): ►M5 2001/83/EC ◄ and which is liable to act upon the human body with action ancillary to that of
p.(None): the device, hereinafter referred to as a ‘human blood derivative’, ►M5 that device shall ◄ be assessed
p.(None): and authorised in accordance with this Directive.
p.(None):
p.(None): ▼B
p.(None): 5. ►M5 This Directive shall not apply to: ◄
p.(None):
p.(None): (a) in vitro diagnostic devices;
p.(None):
p.(None): (b) active implantable devices covered by Directive 90/385/EEC;
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
...
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): ▼M1
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): Article 14
p.(None): Registration of persons responsible for placing devices on the market
p.(None):
p.(None): 1. Any manufacturer who, under his own name, places devices on the market in accordance with the
p.(None): procedures referred to in Article 11
p.(None): (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall
p.(None): inform the competent authorities of the Member State in which he has his registered place of business of the address of
p.(None): the registered place of business and the description of the devices concerned.
p.(None):
p.(None): For all medical devices of ►M5 classes IIa, IIb and III ◄, Member States may request to be informed of all
p.(None): data allowing for identification of such devices together with the label and the instructions for use when such
p.(None): devices are put into service within their territory.
p.(None):
p.(None): 2. Where a manufacturer who places a device on the market under his own name does not have a registered
p.(None): place of business in a Member State, he shall designate a single authorised representative in the
p.(None): European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised
p.(None): representative shall inform the competent authority of the Member State in which he has his registered
p.(None): place of business of the details referred to in paragraph 1.
p.(None): 3. The Member States shall on request inform the other Member States and the Commission of the details referred to
p.(None): in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.
p.(None):
p.(None):
p.(None): Article 14a
p.(None): European databank
p.(None):
p.(None): 1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to
p.(None): the competent authorities to enable them to carry out their tasks relating to this Directive on a well-
p.(None): informed basis.
p.(None): The databank shall contain the following:
p.(None):
p.(None): (a) data relating to registration of manufacturers and authorised repre- sentatives and devices in accordance
p.(None): with Article 14 excluding data related to custom-made devices;
p.(None):
p.(None): (b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused
p.(None): according to the procedures, as laid down in Annexes II to VII;
p.(None): (c) data obtained in accordance with the vigilance procedure as defined in Article 10;
p.(None):
p.(None): (d) data relating to clinical investigations referred to in Article 15.
p.(None):
p.(None): 2. Data shall be forwarded in a standardised format.
p.(None):
...
p.(None): products sold in both sterile and non-sterile condition.
p.(None): 9. Construction and environmental properties
p.(None): 9.1. If the device is intended for use in combination with other devices or equipment, the whole
p.(None): combination, including the connection system must be safe and must not impair the specified performances
p.(None): of the devices. Any restrictions on use must be indicated on the label or in the instructions for use.
p.(None):
p.(None): 9.2. Devices must be designed and manufactured in such a way as to remove or minimize as far
p.(None): as is possible:
p.(None):
p.(None): — the risk of injury, in connection with their physical features, including the volume/pressure
p.(None): ratio, dimensional and where appro- priate ergonomic features,
p.(None):
p.(None): — risks connected with reasonably foreseeable environmental conditions, such as magnetic fields,
p.(None): external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure
p.(None): and acceleration,
p.(None):
p.(None): — the risks of reciprocal interference with other devices normally used in the investigations or for the
p.(None): treatment given,
p.(None):
p.(None): — risks arising where maintenance or calibration are not possible (as with implants), from ageing of
p.(None): materials used or loss of accuracy of any measuring or control mechanism.
p.(None):
p.(None): 9.3. Devices must be designed and manufactured in such a way as to minimize the risks of fire
p.(None): or explosion during normal use and in single fault condition. Particular attention must be paid to
p.(None): devices whose intended use includes exposure to flammable substances or to substances which could cause
p.(None): combustion.
p.(None): 10. Devices with a measuring function
p.(None): 10.1. Devices with a measuring function must be designed and manufactured in such a way as to provide
p.(None): sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended
p.(None): purpose of the device. The limits of accuracy must be indicated by the manufacturer.
p.(None):
p.(None): 10.2. The measurement, monitoring and display scale must be designed in line with ergonomic principles,
p.(None): taking account of the intended purpose of the device.
p.(None):
p.(None): 10.3. The measurements made by devices with a measuring function must be expressed in legal units
p.(None): conforming to the provisions of Council Directive 80/181/EEC (1).
p.(None):
p.(None): 11. Protection against radiation
p.(None): 11.1. General
p.(None): 11.1.1. Devices shall be designed and manufactured in such a way that exposure of patients,
p.(None): users and other persons to radiation shall be reduced as far as possible compatible with the
p.(None): intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic
p.(None): and diagnostic purposes.
p.(None):
p.(None): (1) OJ No L 39, 15.2.1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ No L 357,
p.(None): 7.12.1989, p. 28).
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 29
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
...
p.(None): as possible.
p.(None):
p.(None): 11.4. Instructions
p.(None): 11.4.1. The operating instructions for devices emitting radiation must give detailed information as to
p.(None): the nature of the emitted radiation, means of protecting the patient and the user and on ways of avoiding
p.(None): misuse and of eliminating the risks inherent in installation.
p.(None):
p.(None): 11.5. Ionizing radiation
p.(None): 11.5.1. Devices intended to emit ionizing radiation must be designed and manufactured in such a way
p.(None): as to ensure that, where practicable, the quantity, geometry and quality of radiation emitted can be
p.(None): varied and controlled taking into account the intended use.
p.(None):
p.(None): 11.5.2. Devices emitting ionizing radiation intended for diagnostic radiology shall be designed and
p.(None): manufactured in such a way as to achieve appro- priate image and/or output quality for the intended medical
p.(None): purpose whilst minimizing radiation exposure of the patient and user.
p.(None):
p.(None): 11.5.3. Devices emitting ionizing radiation, intended for therapeutic radiology shall be designed and
p.(None): manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type and energy
p.(None): and where appropriate the quality of radiation.
p.(None):
p.(None): 12. Requirements for medical devices connected to or equipped with an energy source
p.(None): 12.1. Devices incorporating electronic programmable systems must be designed to ensure the
p.(None): repeatability, reliability and performance of these systems according to the intended use. In the event
p.(None): of a single fault condition (in the system) appropriate means should be adopted to eliminate or reduce as far as
p.(None): possible consequent risks.
p.(None):
p.(None):
p.(None): 12.1a For devices which incorporate software or which are medical software in themselves, the software
p.(None): must be validated according to the state of the art taking into account the principles of development lifecycle, risk
p.(None): management, validation and verification.
p.(None):
p.(None):
p.(None): 12.2. Devices where the safety of the patients depends on an internal power supply must be equipped with a
p.(None): means of determining the state of the power supply.
p.(None):
p.(None): 12.3. Devices where the safety of the patients depends on an external power supply must include an alarm
p.(None): system to signal any power failure.
p.(None):
p.(None): 12.4. Devices intended to monitor one or more clinical parameters of a patient must be equipped
p.(None): with appropriate alarm systems to alert the user of situations which could lead to death or severe
p.(None): deterioration of the patient's state of health.
p.(None):
p.(None): 12.5. Devices must be designed and manufactured in such a way as to minimize the risks of
p.(None): creating electromagnetic fields which could impair the operation of other devices or equipment in the
p.(None): usual envir- onment.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 30
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 12.6. Protection against electrical risks
p.(None): Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental
p.(None): electric shocks during normal use and in single fault condition, provided the devices are installed
p.(None): correctly.
p.(None): 12.7. Protection against mechanical and thermal risks
p.(None): 12.7.1. Devices must be designed and manufactured in such a way as to protect the patient and user
p.(None): against mechanical risks connected with, for example, resistance, stability and moving parts.
p.(None): 12.7.2. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the
p.(None): risks arising from vibration generated by the devices, taking account of technical progress and of the
p.(None): means available for limiting vibrations, particularly at source, unless the vibrations are part of
p.(None): the specified performance.
p.(None): 12.7.3. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the
p.(None): risks arising from the noise emitted, taking account of technical progress and of the means available to
p.(None): reduce noise, particularly at source, unless the noise emitted is part of the specified performance.
p.(None): 12.7.4. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy
p.(None): supplies which the user has to handle must be designed and constructed in such a way as to minimize
p.(None): all possible risks.
p.(None): 12.7.5. Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given
p.(None): temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use.
...
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M2
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 13.2. Where appropriate, this information should take the form of symbols. Any symbol or
p.(None): identification colour used must conform to the harmonized standards. In areas for which no
p.(None): standards exist, the symbols and colours must be described in the documentation supplied with the
p.(None): device.
p.(None): 13.3. The label must bear the following particulars:
p.(None):
p.(None): (a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view
p.(None): of their distribution in the Community, the label, or the outer packaging, or instructions for
p.(None): use, shall contain in addition the name and address of the authorised representative where the
p.(None): manufacturer does not have a registered place of business in the Community;
p.(None): (b) the details strictly necessary to identify the device and the contents of the packaging especially for the
p.(None): users;
p.(None):
p.(None): (c) where appropriate, the word ‘STERILE’;
p.(None): (d) where appropriate, the batch code, preceded by the word ‘LOT’, or the serial number;
p.(None): (e) where appropriate, an indication of the date by which the device should be used, in safety,
p.(None): expressed as the year and month;
p.(None):
p.(None): (f) where appropriate, an indication that the device is for single use. A manufacturer's indication of single use
p.(None): must be consistent across the Community;
p.(None):
p.(None): (g) if the device is costum-made, the words ‘custom-made device’;
p.(None): (h) if the device is intended for clinical investigations, the words
p.(None): ‘exclusively for clinical investigations’;
p.(None): (i) any special storage and/or handling conditions;
p.(None): (j) any special operating instructions;
p.(None): (k) any warnings and/or precautions to take;
p.(None): (l) year of manufacture for active devices other than those covered by (e). This indication may be included in the
p.(None): batch or serial number;
p.(None): (m) where applicable, method of sterilization;
p.(None):
p.(None): (n) in the case of a device within the meaning of Article 1(4a), an indication that the device
p.(None): contains a human blood derivative.
p.(None):
p.(None): 13.4. If the intended purpose of the device is not obvious to the user, the manufacturer must
p.(None): clearly state it on the label and in the instructions for use.
p.(None): 13.5. Wherever reasonable and practicable, the devices and detachable components must be
p.(None): identified, where appropriate in terms of batches, to allow all appropriate action to detect any
p.(None): potential risk posed by the devices and detachable components.
p.(None): 13.6. Where appropriate, the instructions for use must contain the following particulars:
p.(None): (a) the details referred to in Section 13.3, with the exception of (d) and (e);
p.(None): (b) the performances referred to in Section 3 and any undesirable side- effects;
p.(None): (c) if the device must be installed with or connected to other medical devices or equipment in
...
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): (d) all the information needed to verify whether the device is properly installed and can operate correctly and
p.(None): safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the
p.(None): devices operate properly and safely at all times;
p.(None): (e) where appropriate, information to avoid certain risks in connection with implantation of the device;
p.(None): (f) information regarding the risks of reciprocal interference posed by the presence of the device
p.(None): during specific investigations or treatment;
p.(None): (g) the necessary instructions in the event of damage to the sterile packaging and, where appropriate,
p.(None): details of appropriate methods of resterilization;
p.(None): (h) if the device is reusable, information on the appropriate processes to allow reuse, including
p.(None): cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be
p.(None): resterilized, and any restriction on the number of reuses.
p.(None): Where devices are supplied with the intention that they be ster- ilized before use, the instructions for
p.(None): cleaning and sterilization must be such that, if correctly followed, the device will still comply with the
p.(None): requirements in Section I.
p.(None):
p.(None): If the device bears an indication that the device is for single use, information on known
p.(None): characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be
p.(None): re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be
p.(None): made available to the user upon request;
p.(None):
p.(None): (i) details of any further treatment or handling needed before the device can be used (for example,
p.(None): sterilization, final assembly, etc.);
p.(None): (j) in the case of devices emitting radiation for medical purposes, details of the nature, type,
p.(None): intensity and distribution of this radiation.
p.(None): The instructions for use must also include details allowing the medical staff to brief the patient on any
p.(None): contra-indications and any precautions to be taken. These details should cover in particular:
p.(None): (k) precautions to be taken in the event of changes in the performance of the device;
p.(None): (l) precautions to be taken as regards exposure, in reasonably fore- seeable environmental conditions, to
p.(None): magnetic fields, external elec- trical influences, electrostatic discharge, pressure or variations in pressure,
p.(None): acceleration, thermal ignition sources, etc.;
p.(None): (m) adequate information regarding the medicinal product or products which the device in question is
p.(None): designed to administer, including any limitations in the choice of substances to be delivered;
p.(None): (n) precautions to be taken against any special, unusual risks related to the disposal of the device;
p.(None):
p.(None): (o) medicinal substances, or human blood derivatives incorporated into the device as an integral part in
p.(None): accordance with Section 7.4;
...
p.(None): the death of a patient or user or to a serious deterioration in his state of health;
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 49
p.(None):
p.(None): ▼B
p.(None): (ii) any technical or medical reason connected with the characteristics on the performance of a device for
p.(None): the reasons referred to in subparagraph
p.(None): (i) leading to systematic recall of devices of the same type by the manufacturer.
p.(None): 5. With products placed on the market in sterile condition and Class I devices with a measuring function, the
p.(None): manufacturer must observe not only the provisions laid down in this Annex but also one of the
p.(None): procedures referred to in ►M5 Annex II, IV, V or VI ◄. Application of the above- mentioned Annexes and
p.(None): the intervention by the notified body is limited to:
p.(None): — in the case of products placed on the market in sterile condition, only the aspects of manufacture
p.(None): concerned with securing and maintaining sterile conditions,
p.(None): — in the case of devices with a measuring function, only the aspects of manufacture concerned with the
p.(None): conformity of the products with the metrological requirements.
p.(None): Section 6.1. of this Annex is applicable.
p.(None): 6. Application to devices in Class IIa
p.(None): In line with Article 11 (2), this Annex may apply to products in Class IIa, subject to the following derogation:
p.(None): 6.1. where this Annex is applied in conjunction with the procedure referred to in Annex IV, V or VI,
p.(None): the declaration of conformity referred to in the abovementioned Annexes forms a single declaration.
p.(None): As regards the declaration based on this Annex, the manufacturer must ensure and declare that
p.(None): the product design meets the provisions of this Directive which apply to it.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 50
p.(None):
p.(None): ▼B
p.(None): ANNEX VIII
p.(None):
p.(None): STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES
p.(None):
p.(None): 1. For custom-made devices or for devices intended for clinical investigations the
p.(None): manufacturer or his authorized representative ►M5 ◄ must
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None): draw up the statement containing the information stipulated in Section 2.
p.(None): 2. The statement must contain the following information:
p.(None): 2.1. for custom-made devices:
p.(None):
p.(None): — the name and address of the manufacturer,
p.(None):
p.(None): — data allowing identification of the device in question,
p.(None): — a statement that the device is intended for exclusive use by a particular patient, together with the name of
p.(None): the patient,
p.(None): — the name of the medical practitioner or other authorized person who made out the prescription and, where
p.(None): applicable, the name of the clinic concerned,
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): ▼M1
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): Article 14
p.(None): Registration of persons responsible for placing devices on the market
p.(None):
p.(None): 1. Any manufacturer who, under his own name, places devices on the market in accordance with the
p.(None): procedures referred to in Article 11
p.(None): (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall
p.(None): inform the competent authorities of the Member State in which he has his registered place of business of the address of
p.(None): the registered place of business and the description of the devices concerned.
p.(None):
p.(None): For all medical devices of ►M5 classes IIa, IIb and III ◄, Member States may request to be informed of all
p.(None): data allowing for identification of such devices together with the label and the instructions for use when such
p.(None): devices are put into service within their territory.
p.(None):
p.(None): 2. Where a manufacturer who places a device on the market under his own name does not have a registered
p.(None): place of business in a Member State, he shall designate a single authorised representative in the
p.(None): European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised
p.(None): representative shall inform the competent authority of the Member State in which he has his registered
p.(None): place of business of the details referred to in paragraph 1.
p.(None): 3. The Member States shall on request inform the other Member States and the Commission of the details referred to
p.(None): in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.
p.(None):
p.(None):
p.(None): Article 14a
p.(None): European databank
p.(None):
p.(None): 1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to
p.(None): the competent authorities to enable them to carry out their tasks relating to this Directive on a well-
p.(None): informed basis.
p.(None): The databank shall contain the following:
p.(None):
p.(None): (a) data relating to registration of manufacturers and authorised repre- sentatives and devices in accordance
p.(None): with Article 14 excluding data related to custom-made devices;
p.(None):
p.(None): (b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused
p.(None): according to the procedures, as laid down in Annexes II to VII;
p.(None): (c) data obtained in accordance with the vigilance procedure as defined in Article 10;
p.(None):
p.(None): (d) data relating to clinical investigations referred to in Article 15.
p.(None):
p.(None): 2. Data shall be forwarded in a standardised format.
p.(None):
p.(None): 3. The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in
...
Social / Women
Searching for indicator women:
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p.(None): into account in reconsidering its assessment of the conformity assessment procedure.
p.(None): 7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the
p.(None): risks posed by substances leaking from the device. Special attention shall be given to substances which
p.(None): are carci- nogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council
p.(None): Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative
p.(None): provisions relating to the classification, packaging and labelling of dangerous substances (1).
p.(None): If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids
p.(None): or other substances to or from the body, or devices intended for transport and storage of such body
p.(None): fluids or substances, contain phthalates which are classified as carci- nogenic, mutagenic or toxic to
p.(None): reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these
p.(None): devices must be labelled on the device itself and/or on the packaging for each unit or, where
p.(None): appropriate, on the sales packaging as a device containing phthalates.
p.(None): If the intended use of such devices includes treatment of children or treatment of pregnant or
p.(None): nursing women, the manufacturer must provide a specific justification for the use of these substances
p.(None): with regard to compliance with the essential requirements, in particular of this paragraph, within the
p.(None): technical documentation and, within the instructions for use, information on residual risks for these
p.(None): patient groups and, if applicable, on appropriate precautionary measures.
p.(None):
p.(None): 7.6. Devices must be designed and manufactured in such a way as to reduce, as much as possible,
p.(None): risks posed by the unintentional ingress of substances into the device taking into account the device
p.(None): and the nature of the environment in which it is intended to be used.
p.(None): 8. Infection and microbial contamination
p.(None): 8.1. The devices and manufacturing processes must be designed in such a way as to eliminate or
p.(None): reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy
p.(None): handling and, where necessary, minimize contamination of the device by the patient or vice versa during
p.(None): use.
p.(None): 8.2. Tissues of animal origin must originate from animals that have been subjected to veterinary
p.(None): controls and surveillance adapted to the intended use of the tissues.
p.(None): Notified bodies shall retain information on the geographical origin of the animals.
p.(None): Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be
p.(None): carried out so as to provide optimal security. In particular safety with regard to viruses and other
...
Social / education
Searching for indicator education:
(return to top)
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): ANNEX I
p.(None):
p.(None): ESSENTIAL REQUIREMENTS
p.(None):
p.(None): I. GENERAL REQUIREMENTS
p.(None):
p.(None): 1. The devices must be designed and manufactured in such a way that, when used under the
p.(None): conditions and for the purposes intended, they will not compromise the clinical condition or the safety of
p.(None): patients, or the safety and health of users or, where applicable, other persons, provided that any risks
p.(None): which may be associated with their intended use constitute acceptable risks when weighed against the benefits to
p.(None): the patient and are compatible with a high level of protection of health and safety.
p.(None): This shall include:
p.(None): — reducing, as far as possible, the risk of use error due to the ergonomic features of the device
p.(None): and the environment in which the device is intended to be used (design for patient safety), and
p.(None): — consideration of the technical knowledge, experience, education and training and where applicable the medical
p.(None): and physical conditions of intended users (design for lay, professional, disabled or other users).
p.(None):
p.(None): 2. The solutions adopted by the manufacturer for the design and construction of the
p.(None): devices must conform to safety principles, taking account of the generally acknowledged state of the art.
p.(None): In selecting the most appropriate solutions, the manufacturer must apply the following principles in the
p.(None): following order:
p.(None): — eliminate or reduce risks as far as possible (inherently safe design and construction),
p.(None): — where appropriate take adequate protection measures including alarms if necessary, in relation to
p.(None): risks that cannot be eliminated,
p.(None): — inform users of the residual risks due to any shortcomings of the protection measures adopted.
p.(None): 3. The devices must achieve the performances intended by the manu- facturer and be designed,
p.(None): manufactured and packaged in such a way that they are suitable for one or more of the functions
p.(None): referred to in Article 1 (2) (a), as specified by the manufacturer.
p.(None): 4. The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely
p.(None): affected to such a degree that the clinical conditions and safety of the patients and, where applicable,
p.(None): of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None):
p.(None):
p.(None): ►B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993
p.(None): concerning medical devices
p.(None):
p.(None): (OJ L 169, 12.7.1993, p. 1)
p.(None):
p.(None):
p.(None):
p.(None): Amended by:
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ►M1 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998
p.(None): ►M2 Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000
p.(None): ►M3 Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001
p.(None): ►M4 Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003
p.(None): ►M5 Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007
p.(None): Official Journal
p.(None):
p.(None): No page date
p.(None): L 331 1 7.12.1998
p.(None): L 313 22 13.12.2000
p.(None): L 6 50 10.1.2002
p.(None): L 284 1 31.10.2003
p.(None): L 247 21 21.9.2007
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 2
p.(None):
p.(None): ▼B
p.(None): COUNCIL DIRECTIVE 93/42/EEC
p.(None): of 14 June 1993 concerning medical devices
p.(None):
p.(None): THE COUNCIL OF THE EUROPEAN COMMUNITIES,
p.(None): Having regard to the Treaty establishing the European Economic Community, and in particular Article
p.(None): 100a thereof,
p.(None): Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2),
p.(None): Having regard to the opinion of the Economic and Social Committee (3),
p.(None): Whereas measures should be adopted in the context of the internal market; whereas the internal market
p.(None): is an area without internal frontiers in which the free movement of goods, persons, services and
p.(None): capital is ensured;
p.(None): Whereas the content and scope of the laws, regulations and adminis- trative provisions in force in the
p.(None): Member States with regard to the safety, health protection and performance characteristics of medical
p.(None): devices are different; whereas the certification and inspection procedures for such devices differ from one Member
p.(None): State to another; whereas such disparities constitute barriers to trade within the Community;
p.(None): Whereas the national provisions for the safety and health protection of patients, users and, where
p.(None): appropriate, other persons, with regard to the use of medical devices should be harmonized in order to
p.(None): guarantee the free movement of such devices within the internal market;
p.(None): Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to
p.(None): manage the funding of public health and sickness insurance schemes relating directly or indirectly
p.(None): to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to
p.(None): implement the abovemen- tioned measures provided Community law is complied with;
p.(None): Whereas medical devices should provide patients, users and third parties with a high level of protection
...
p.(None): functioning and the added value of the
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 18
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to
p.(None): the European Parliament and the Council or present draft measures in accordance with paragraph 3.
p.(None):
p.(None): Article 14b
p.(None): Particular health monitoring measures
p.(None):
p.(None): Where a Member State considers, in relation to a given product or group of products, that, in order to
p.(None): ensure protection of health and safety and/or to ensure that public health requirements are observed,
p.(None): such products should be withdrawn from the market, or their placing on the market and putting into service
p.(None): should be prohibited, restricted or subjected to particular requirements, it may take any necessary and
p.(None): justified transitional measures.
p.(None): The Member State shall then inform the Commission and all other Member States, giving the reasons for
p.(None): its decision.
p.(None): The Commission shall, whenever possible, consult the interested Parties and the Member States.
p.(None): The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The
p.(None): Commission shall inform all the Member States and the consulted interested Parties thereof.
p.(None): When appropriate, the necessary measures designed to amend non- essential elements of this Directive,
p.(None): relating to withdrawal from the market, prohibition of placing on the market and putting into service of
p.(None): a certain product or group of products or to restrictions or intro- duction of particular requirements
p.(None): in order for such products to be put on the market, shall be adopted in accordance with the regulatory
p.(None): procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the
p.(None): Commission may use the urgency procedure referred to in Article 7(4).
p.(None): Article 15
p.(None): Clinical investigation
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): 1. In the case of devices intended for clinical investigations, the manufacturer or the authorised
p.(None): representative, established in the Community, shall follow the procedure referred to in Annex VIII and
p.(None): notify the competent authorities of the Member States in which the investigations are to be conducted
p.(None): by means of the statement mentioned in Section 2.2 of Annex VIII.
p.(None): 2. In the case of devices falling within Class III and implantable and long-term invasive devices falling
p.(None): within Class IIa or IIb, the manu- facturer may commence the relevant clinical investigation at the end
p.(None): of a period of 60 days after notification, unless the competent authorities have notified him within that
p.(None): period of a decision to the contrary based on considerations of public health or public policy.
p.(None): Member States may however authorise manufacturers to commence the relevant clinical investigations before the
p.(None): expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable
p.(None): opinion on the programme of investigation in question, including its review of the clinical investigation
p.(None): plan.
p.(None): 3. In the case of devices other than those referred to in paragraph 2, Member States may authorise
p.(None): manufacturers to commence clinical investigations immediately after the date of notification, provided
p.(None): that the ethics committee concerned has issued a favourable opinion on the programme of investigation in
p.(None): question including its review of the clinical investigation plan.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 19
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 4. The authorization referred to in paragraph 2 second subparagraph and paragraph 3, may be made
p.(None): subject to authorization from the competent authority.
p.(None):
p.(None): 5. The clinical investigations must be conducted in accordance with the provisions of Annex X. The
p.(None): measures designed to amend non- essential elements of this Directive, inter alia by supplementing it,
p.(None): relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the
p.(None): regulatory procedure with scrutiny referred to in Article 7(3).
p.(None): 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public
p.(None): policy. Where a clinical investigation is refused or halted by a Member State, that Member State
...
p.(None): Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 and 2
p.(None): have not been carried out and the use of which is in the interest of protection of health.’;
p.(None): 3. the following Article 9a is inserted after Article 9:
p.(None):
p.(None): ‘Article 9a
p.(None): 1. Where a Member State considers that the conformity of a device or family of devices should be
p.(None): established, by way of dero- gation from the provisions of Article 9, by applying solely one of the
p.(None): given procedures chosen from among those referred to in Article 9, it shall submit a duly substantiated request to the
p.(None): Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with
p.(None): the procedure referred to in Article 7
p.(None): (2) of Directive 93/42/EEC (*).
p.(None): 2. The Commission shall inform the Member States of the measures taken and, where appropriate,
p.(None): publish the relevant parts of these measures in the Official Journal of the European Commu- nities.
p.(None):
p.(None): (*) OJ No L 169, 12.7.1993, p. 1.’
p.(None):
p.(None): 4. Article 10 shall be amended as follows:
p.(None): — the following subparagraph shall be added to paragraph 2:
p.(None): ‘Member States may however authorize manufacturers to start the clinical investigations in question before the
p.(None): expiry of the 60- day period, provided that the Ethical Committee concerned has delivered a favourable
p.(None): opinion with respect to the investigation programme in question.’,
p.(None): — the following paragraph shall be inserted:
p.(None): ‘2a. The authorization referred to in the second subparagraph of paragraph 2 may be subject to
p.(None): approval by the competent authority.’;
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 24
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 5. the following is added to Article 14:
p.(None): ‘In the event of a decision as referred to in the previous paragraph the manufacturer, or his
p.(None): authorized representative established in the Community, shall have an opportunity to put forward his viewpoint
p.(None): in advance, unless such consultation is not possible because of the urgency of the measures to be
p.(None): taken.’
p.(None):
p.(None): Article 22
p.(None): Implementation, transitional provisions
p.(None):
p.(None): 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary
p.(None): to comply with this Directive not later than 1 July 1994. They shall immediately inform the Commission
p.(None): thereof.
p.(None): The Standing Committee referred to in Article 7 may assume its tasks from the date of notification (1)
...
p.(None): paid to the tissues exposed and to the duration and frequency of exposure.
p.(None): 7.3. The devices must be designed and manufactured in such a way that they can be used safely
p.(None): with the materials, substances and gases with which they enter into contact during their normal use or during
p.(None): routine procedures; if the devices are intended to administer medicinal products they must be designed and
p.(None): manufactured in such a way as to be compatible with the medicinal products concerned according to the
p.(None): provisions and restrictions governing these products and that their performance is maintained in accordance
p.(None): with the intended use.
p.(None):
p.(None): 7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be
p.(None): considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is
p.(None): liable to act upon the body with action ancillary to that of the device, the quality, safety and
p.(None): usefulness of the substance must be verified by analogy with the methods specified in Annex I to
p.(None): Directive 2001/83/ EC.
p.(None): For the substances referred to in the first paragraph, the notified body shall, having verified the
p.(None): usefulness of the substance as part of the medical device and taking account of the intended purpose of
p.(None): the device, seek a scientific opinion from one of the competent authorities designated by the Member States or
p.(None): the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation
p.(None): (EC) No 726/2004 (1) on the quality and safety of the substance including the clinical benefit/risk profile
p.(None): of the incorporation of the substance into the device. When issuing its opinion, the competent
p.(None): authority or the EMEA shall take into account the manu- facturing process and the data related to the
p.(None): usefulness of incorporation of the substance into the device as determined by the notified body.
p.(None): Where a device incorporates, as an integral part, a human blood deri- vative, the notified body shall,
p.(None): having verified the usefulness of the substance as part of the medical device and taking into account
p.(None): the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through
p.(None): its committee, on the quality and safety of the substance including the clinical benefit/risk profile of
p.(None): the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall
p.(None): take into account the manufac- turing process and the data related to the usefulness of incorporation of the
p.(None): substance into the device as determined by the notified body.
p.(None): Where changes are made to an ancillary substance incorporated in a device, in particular related to its
p.(None): manufacturing process, the notified body shall be informed of the changes and shall consult the relevant
p.(None): medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm
p.(None): that the quality and safety of the ancillary substance are maintained. The competent authority
p.(None): shall take into account the data related to the usefulness of incorporation of the substance into the device
p.(None): as determined by the notified body, in
p.(None):
p.(None): (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying
p.(None): down Community procedures for the authorisation and super- vision of medicinal products for human and
p.(None): veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as
p.(None): last amended by Regu- lation (EC) No 1901/2006.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 27
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): order to ensure that the changes have no negative impact on the estab- lished benefit/risk profile of the
p.(None): addition of the substance in the medical device.
p.(None): When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained
p.(None): information on the ancillary substance, which could have an impact on the established benefit/risk profile
p.(None): of the addition of the substance in the medical device, it shall provide the notified body with advice,
p.(None): whether this information has an impact on the established benefit/risk profile of the addition of the
p.(None): substance in the medical device or not. The notified body shall take the updated scientific opinion
p.(None): into account in reconsidering its assessment of the conformity assessment procedure.
p.(None): 7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the
p.(None): risks posed by substances leaking from the device. Special attention shall be given to substances which
p.(None): are carci- nogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council
p.(None): Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative
p.(None): provisions relating to the classification, packaging and labelling of dangerous substances (1).
p.(None): If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids
p.(None): or other substances to or from the body, or devices intended for transport and storage of such body
p.(None): fluids or substances, contain phthalates which are classified as carci- nogenic, mutagenic or toxic to
p.(None): reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these
p.(None): devices must be labelled on the device itself and/or on the packaging for each unit or, where
p.(None): appropriate, on the sales packaging as a device containing phthalates.
p.(None): If the intended use of such devices includes treatment of children or treatment of pregnant or
p.(None): nursing women, the manufacturer must provide a specific justification for the use of these substances
...
p.(None): 4. Examination of the design of the product
p.(None): 4.1. In addition to the obligations imposed by Section 3, the manufacturer must lodge with the notified body an
p.(None): application for examination of the design dossier relating to the product which he plans to manufacture
p.(None): and which falls into the category referred to in Section 3.1.
p.(None): 4.2. The application must describe the design, manufacture and performances of the product in question. It must
p.(None): include the documents needed to assess whether the product conforms to the requirements of this
p.(None): Directive, as referred to in Section 3.2 (c).
p.(None): 4.3. The notified body must examine the application and, if the product conforms to the
p.(None): relevant provisions of this Directive, issue the application with an EC design-examination certificate. The
p.(None): notified body may require the application to be completed by further tests or proof to allow
p.(None): assessment of conformity with the requirements of the Directive. The certi- ficate must contain the conclusions of
p.(None): the examination, the conditions of validity, the data needed for identification of the approved design,
p.(None): where appropriate, a description of the intended purpose of the product.
p.(None):
p.(None): In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified
p.(None): body shall, as regards the aspects referred to in that section, consult one of the competent authorities
p.(None): designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a
p.(None): decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days
p.(None): after receipt of valid documentation. The scientific opinion of the competent national authority or the
p.(None): EMEA must be included in the documentation concerning the device. The notified body will give due
p.(None): consideration to the views expressed in this consultation when making its decision. It will convey its
p.(None): final decision to the competent body concerned.
p.(None): In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be
p.(None): included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after
p.(None): receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA
p.(None): when making its decision. The notified body may not deliver the certificate if the EMEA's scientific
p.(None): opinion is unfavourable. It will convey its final decision to the EMEA.
p.(None): In the case of devices manufactured utilising tissues of animal origin as referred to in Directive
p.(None): 2003/32/EC, the notified body must follow the procedures referred to in that Directive.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 36
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 4.4. Changes to the approved design must receive further approval from the notified body which issued the
p.(None): EC design-examination certificate wherever the changes could affect conformity with the essential requirements
p.(None): of the Directive or with the conditions prescribed for use of the product. The applicant shall inform the
p.(None): notified body which issued the EC design-exam- ination certificate of any such changes made to the approved
p.(None): design. This additional approval must take the form of a supplement to the EC design- examination
p.(None): certificate.
p.(None): 5. Surveillance
p.(None): 5.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by
p.(None): the approved quality system.
p.(None): 5.2. The manufacturer must authorize the notified body to carry out all the necessary inspections and
p.(None): supply it with all relevant information, in particular:
p.(None): — the documentation on the quality system,
p.(None):
p.(None): — the data stipulated in the part of the quality system relating to design, such as the results of
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): conforms to the essential requirements when connected to any such device
p.(None): (s) having the characteristics specified by the manufacturer;
p.(None): 4.3. carry out or arrange for the appropriate inspections and the tests necessary to verify whether, if the
p.(None): manufacturer has chosen to apply the relevant standards, these have actually been applied;
p.(None): 4.4. agree with the applicant on the place where the necessary inspections and tests will be caried
p.(None): out.
p.(None): 5. If the type conforms to the provisions of this Directive, the notified body issues the applicant
p.(None): with an EC type-examination certificate. The certificate must contain the name and address of the manufacturer, the
p.(None): conclusions of the inspection, the conditions of validity and the data needed for identifi- cation of the
p.(None): type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept
p.(None): by the notified body.
p.(None):
p.(None): In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified
p.(None): body shall, as regards the aspects referred to in that section, consult one of the authorities
p.(None): designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a
p.(None): decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after
p.(None): receipt of valid documen- tation. The scientific opinion of the competent national authority or the EMEA
p.(None): must be included in the documentation concerning the device. The notified body will give due
p.(None): consideration to the views expressed in this consultation when making its decision. It will convey its final
p.(None): decision to the competent body concerned.
p.(None): In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be
p.(None): included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after
p.(None): receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA
p.(None): when making its decision. The notified body may not deliver the certificate if the EMEA's scientific
p.(None): opinion is unfavourable. It will convey its final decision to the EMEA.
p.(None): In the case of devices manufactured utilising tissues of animal origin as referred to in Directive
p.(None): 2003/32/EC, the notified body must follow the procedures referred to in that Directive.
p.(None):
p.(None): 6. The applicant must inform the notified body which issued the EC type- examination certificate of
p.(None): any significant change made to the approved product.
p.(None): Changes to the approved product must receive further approval from the notified body which issued the EC
p.(None): type-examination certificate wherever the changes may affect conformity with the essential requirements or
p.(None): with the conditions prescribed for use of the product. This new approval must, where appropriate, take
p.(None): the form of a supplement to the initial EC type- examination certificate.
p.(None): 7. Administrative provisions
p.(None): ▼M1
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None): 7.2. Other notified bodies may obtain a copy of the EC type-examination certi- ficates and/or the supplements
p.(None): thereto. The Annexes to the certificates must be made available to other notified bodies on reasoned application, after
p.(None): the manufacturer has been informed.
p.(None):
p.(None): 7.3. The manufacturer or his authorised representative must keep with the technical documentation copies
p.(None): of EC type-examination certificates and their additions for a period ending at least five years after
p.(None): the last device has been manufactured. In the case of implantable devices, the period shall be at least 15 years
p.(None): after the last product has been manufactured.
p.(None):
p.(None): 1993L0042
...
p.(None):
p.(None): — the name and address of the manufacturer,
p.(None):
p.(None): — data allowing identification of the device in question,
p.(None): — a statement that the device is intended for exclusive use by a particular patient, together with the name of
p.(None): the patient,
p.(None): — the name of the medical practitioner or other authorized person who made out the prescription and, where
p.(None): applicable, the name of the clinic concerned,
p.(None):
p.(None): — the specific characteristics of the product as indicated by the prescription,
p.(None):
p.(None): — a statement that the device in question conforms to the essential requirements set out in
p.(None): Annex I and, where applicable, indicating which essential requirements have not been fully met, together
p.(None): with the grounds;
p.(None): 2.2. for devices intended for the clinical investigations covered by Annex X:
p.(None): — data allowing identification of the device in question,
p.(None):
p.(None): — the clinical investigation plan,
p.(None): — the investigator's brochure,
p.(None): — the confirmation of insurance of subjects,
p.(None): — the documents used to obtain informed consent,
p.(None): — a statement indicating whether or not the device incorporates, as an integral part, a substance or
p.(None): human blood derivative referred to in Section 7.4 of Annex I,
p.(None): — a statement indicating whether or not the device is manufactured utilising tissues of animal
p.(None): origin as referred to in Directive 2003/32/EC,
p.(None):
p.(None): — the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
p.(None): — the name of the medical practitioner or other authorized person and of the institution responsible for
p.(None): the investigations,
p.(None): — the place, starting date and scheduled duration for the investigations,
p.(None): — a statement that the device in question conforms to the essential requirements apart from the
p.(None): aspects covered by the investigations and that, with regard to these aspects, every precaution has been
p.(None): taken to protect the health and safety of the patient.
p.(None): 3. The manufacturer must also undertake to keep available for the competent national authorities:
p.(None):
p.(None): 3.1. For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding
p.(None): of the design, manufacture and perfor- mances of the product, including the expected performances, so as
p.(None): to allow assessment of conformity with the requirements of this Directive.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 51
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): The manufacturer must take all the measures necessary to ensure that the manufacturing process produces
p.(None): products which are manufactured in accordance with the documentation mentioned in the first paragraph;
p.(None):
p.(None): 3.2. For devices intended for clinical investigations, the documentation must contain:
p.(None): — a general description of the product and its intended use,
p.(None): — design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.(None): health and safety requirements of Directive 89/686/EEC shall also be fulfilled.
p.(None): 7. This Directive is a specific Directive within the meaning of Article 1(4) of Directive
p.(None): 2004/108/EC of the European Parliament and of the Council (2).
p.(None): 8. This Directive shall not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying
p.(None): down basic safety standards for the protection of the health of workers and the general public against the dangers
p.(None): arising from ionising radiation (3), nor of Council Directive 97/43/Euratom of 30 June 1997 on health
p.(None): protection of individuals against the dangers of ionising radiation in relation to medical exposure
p.(None): (4).
p.(None): Article 2
p.(None): Placing on the market and putting into service
p.(None):
p.(None): Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service
p.(None): only if they comply with the requirements laid down in this Directive when duly supplied and properly
p.(None): installed, maintained and used in accordance with their intended purpose.
p.(None): ▼B
p.(None):
p.(None): Article 3
p.(None): Essential requirements
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None): The devices must meet the essential requirements set out in Annex I which apply to them, taking account
p.(None): of the intended purpose of the devices concerned.
p.(None):
p.(None): Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive
p.(None): 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (5) shall also meet
p.(None): the essential health and safety requirements set out in Annex I to that Directive to the extent to which those
p.(None): essential health and safety requirements are more specific than the essential requirements set out in Annex I to
p.(None): this Directive.
p.(None):
p.(None): Article 4
p.(None): Free movement, devices intended for special purposes
p.(None):
p.(None): 1. Member States shall not create any obstacle to the placing on the market or the putting into
p.(None): service within their territory of devices bearing the CE marking provided for in Article 17 which
p.(None): indicate
p.(None):
p.(None): (1) Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating
p.(None): to personal protective equipment (OJ L 399, 30.12.1989, p. 18). Directive as last amended by Regulation
p.(None): (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
p.(None): (2) Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the
p.(None): approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390,
p.(None): 31.12.2004, p. 24).
p.(None): (3) OJ L 159, 29.6.1996, p. 1.
p.(None): (4) OJ L 180, 9.7.1997, p. 22.
p.(None): (5) OJ L 157, 9.6.2006, p. 24.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 10
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): in paragraph 1 or to prohibition or restriction of their placement on the market or being put into
p.(None): service or to introduction of particular requirements in order for such products to be put on
p.(None): the market, shall be adopted in accordance with the regulatory procedure with scrutiny
p.(None): referred to in Article 7(3). On imperative grounds of urgency, the Commission may use the urgency
p.(None): procedure referred to in Article 7(4);
p.(None):
p.(None): (b) the measures are unjustified, it shall immediately so inform the Member State which took the
p.(None): measures and the manufacturer or his authorised representative.
p.(None):
p.(None):
p.(None): 3. Where a non-complying device bears the CE marking, the competent Member State shall take
p.(None): appropriate action against whom- soever has affixed the mark and shall inform the Commission and the
p.(None): other Member States thereof.
p.(None):
p.(None): 4. The Commission shall ensure that the Member States are kept informed of the progress and outcome
p.(None): of this procedure.
p.(None):
p.(None):
p.(None): Article 9
p.(None): Classification
p.(None):
p.(None): 1. Devices shall be divided into Classes I, IIa, IIb and III. Classifi- cation shall be carried out
p.(None): in accordance with Annex IX.
p.(None):
p.(None): 2. In the event of a dispute between the manufacturer and the notified body concerned,
p.(None): resulting from the application of the classifi- cation rules, the matter shall be referred for decision
p.(None): to the competent authority to which the notified body is subject.
p.(None):
p.(None):
p.(None): 3. Where a Member State considers that the classification rules set out in Annex IX require adaptation in
p.(None): the light of technical progress and any information which becomes available under the information system provided for
p.(None): in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures
p.(None): for adaptation of classification rules. The measures designed to amend non-essential elements of this
p.(None): Directive relating to adaptation of classification rules shall be adopted in accordance with the
p.(None): regulatory procedure with scrutiny referred to in Article 7(3).
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 13
p.(None):
p.(None): ▼B
p.(None): Article 10
p.(None): Information on incidents occuring following placing of devices on the market
p.(None):
p.(None): 1. Member States shall take the necessary steps to ensure that any information brought to their
p.(None): knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below
p.(None): involving a Class I, IIa, IIb or III device is recorded and evaluated centrally:
p.(None): (a) any malfunction or deterioration in the characteristics and/or performance of a device, as
p.(None): well as any inadequacy in the labelling or the instructions for use which might lead to or might
p.(None): have led to the death of a patient or user or to a serious dete- rioration in his state of health;
p.(None): (b) any technical or medical reason in relation to the characteristics or performance of a device for the
...
p.(None): (i) the procedure relating to the EC verification set out in Annex IV;
p.(None): or
p.(None): (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality
p.(None): assurance);
p.(None): or
p.(None): (iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality
p.(None): assurance).
p.(None): 4. The Commission shall, no later than five years from the date of implementation of this Directive,
p.(None): submit a report to the Council on the operation of the provisions referred to in Article 10 (1),
p.(None): Article 15 (1), in particular in respect of Class I and Class IIa devices, and on the operation of the
p.(None): provisions referred to in Annex II, Section 4.3 second and third subparagraphs and in Annex III,
p.(None): Section 5 second and third subparagraphs to this Directive, accompanied, if necessary, by appro- priate
p.(None): proposals.
p.(None): 5. In the case of devices falling within Class I, other than devices which are custom-made or
p.(None): intended for clinical investigations, the manufacturer shall, in order to affix the CE marking,
p.(None): follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required
p.(None): before placing the device on the market.
p.(None): 6. In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Annex VIII
p.(None): and draw up the statement set out in that Annex before placing each device on the market.
p.(None): Member States may require that the manufacturer shall submit to the competent authority a list of such
p.(None): devices which have been put into service in their territory.
p.(None): 7. During the conformity assessment procedure for a device, the manufacturer and/or the notified body
p.(None): shall take account of the results of any assessment and verification operations which, where appropriate, have
p.(None): been carried out in accordance with this Directive at an inter- mediate stage of manufacture.
p.(None): 8. The manufacturer may instruct his authorized representative
p.(None): ►M5 ◄ to initiate the procedures provided for in
p.(None): Annexes III, IV, VII and VIII.
p.(None): 9. Where the conformity assessment procedure involves the inter- vention of a notified body, the
p.(None): manufacturer, or his authorized repre-
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 15
p.(None):
p.(None):
p.(None): ▼B
p.(None): sentative ►M5
p.(None):
p.(None):
p.(None): ◄, may apply to a body of his choice
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None): within the framework of the tasks for which the body has been notified.
p.(None): 10. The notified body may require, where duly justified, any infor- mation or data, which is necessary
p.(None): for establishing and maintaining the attestation of conformity in view of the chosen procedure.
p.(None): 11. Decisions taken by the notified bodies in accordance with
...
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): ▼M1
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): Article 14
p.(None): Registration of persons responsible for placing devices on the market
p.(None):
p.(None): 1. Any manufacturer who, under his own name, places devices on the market in accordance with the
p.(None): procedures referred to in Article 11
p.(None): (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall
p.(None): inform the competent authorities of the Member State in which he has his registered place of business of the address of
p.(None): the registered place of business and the description of the devices concerned.
p.(None):
p.(None): For all medical devices of ►M5 classes IIa, IIb and III ◄, Member States may request to be informed of all
p.(None): data allowing for identification of such devices together with the label and the instructions for use when such
p.(None): devices are put into service within their territory.
p.(None):
p.(None): 2. Where a manufacturer who places a device on the market under his own name does not have a registered
p.(None): place of business in a Member State, he shall designate a single authorised representative in the
p.(None): European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised
p.(None): representative shall inform the competent authority of the Member State in which he has his registered
p.(None): place of business of the details referred to in paragraph 1.
p.(None): 3. The Member States shall on request inform the other Member States and the Commission of the details referred to
p.(None): in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.
p.(None):
p.(None):
p.(None): Article 14a
p.(None): European databank
p.(None):
p.(None): 1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to
p.(None): the competent authorities to enable them to carry out their tasks relating to this Directive on a well-
p.(None): informed basis.
p.(None): The databank shall contain the following:
p.(None):
p.(None): (a) data relating to registration of manufacturers and authorised repre- sentatives and devices in accordance
p.(None): with Article 14 excluding data related to custom-made devices;
p.(None):
p.(None): (b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused
p.(None): according to the procedures, as laid down in Annexes II to VII;
p.(None): (c) data obtained in accordance with the vigilance procedure as defined in Article 10;
p.(None):
p.(None): (d) data relating to clinical investigations referred to in Article 15.
p.(None):
p.(None): 2. Data shall be forwarded in a standardised format.
p.(None):
p.(None): 3. The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in
p.(None): particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in
p.(None): Article 7(2).
p.(None): 4. The provisions of this Article shall be implemented no later than
...
p.(None): opinion on the programme of investigation in question, including its review of the clinical investigation
p.(None): plan.
p.(None): 3. In the case of devices other than those referred to in paragraph 2, Member States may authorise
p.(None): manufacturers to commence clinical investigations immediately after the date of notification, provided
p.(None): that the ethics committee concerned has issued a favourable opinion on the programme of investigation in
p.(None): question including its review of the clinical investigation plan.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 19
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 4. The authorization referred to in paragraph 2 second subparagraph and paragraph 3, may be made
p.(None): subject to authorization from the competent authority.
p.(None):
p.(None): 5. The clinical investigations must be conducted in accordance with the provisions of Annex X. The
p.(None): measures designed to amend non- essential elements of this Directive, inter alia by supplementing it,
p.(None): relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the
p.(None): regulatory procedure with scrutiny referred to in Article 7(3).
p.(None): 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public
p.(None): policy. Where a clinical investigation is refused or halted by a Member State, that Member State
p.(None): shall communicate its decision and the grounds therefor to all Member States and the Commission.
p.(None): Where a Member State has called for a significant modification or temporary interruption of a clinical
p.(None): investi- gation, that Member State shall inform the Member States concerned about its actions and the
p.(None): grounds for the actions taken.
p.(None): 7. The manufacturer or his authorised representative shall notify the competent authorities of the Member
p.(None): States concerned of the end of the clinical investigation, with a justification in case of early termination. In the
p.(None): case of early termination of the clinical investigation on safety grounds this notification shall be
p.(None): communicated to all Member States and the Commission. The manufacturer or his authorised representative
p.(None): shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent
p.(None): authorities.
p.(None):
p.(None): 8. The provisions of paragraphs 1 and 2 do not apply where the clinical investigations are conducted
...
p.(None): 2. Member States shall apply the criteria set out in Annex XI for the designation of bodies. Bodies that meet
p.(None): the criteria laid down in the national standards which transpose the relevant harmonized standards shall
p.(None): be presumed to meet the relevant criteria.
p.(None):
p.(None): When appropriate in the light of technical progress, the detailed measures necessary to ensure a
p.(None): consistent application of the criteria set out in Annex XI for the designation of bodies by the Member
p.(None): States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
p.(None):
p.(None): 3. A Member State that has notified a body shall withdraw that notification if it finds that
p.(None): the body no longer meets the criteria
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 20
p.(None):
p.(None): ▼B
p.(None): referred to in paragraph 2. It shall immediately inform the other Member States and the
p.(None): Commission thereof.
p.(None): 4. The notified body and the manufacturer, or his authorized repre-
p.(None): sentative ►M5 ◄, shall lay down, by common accord,
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None): the time limits for completion of the assessment and verification operations referred to in
p.(None): Annexes II to VI.
p.(None):
p.(None): 5. The notified body shall inform its competent authority about all certificates issued, modified,
p.(None): supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of
p.(None): this Directive about certificates suspended, withdrawn or refused and, on request, about certificates
p.(None): issued. The notified body shall also make available, on request, all additional relevant information.
p.(None):
p.(None): 6. Where a notified body finds that pertinent requirements of this Directive have not been met or
p.(None): are no longer met by the manufacturer or where a certificate should not have been issued, it shall,
p.(None): taking account of the principle of proportionality, suspend or withdraw the certificate issued or place
p.(None): any restrictions on it unless compliance with such requirements is ensured by the implementation of
p.(None): appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the
p.(None): certificate or of any restriction placed on it or in cases where an intervention of the competent authority
p.(None): may become necessary, the notified body shall inform its competent authority thereof. The Member
p.(None): State shall inform the other Member States and the Commission.
p.(None): 7. The notified body shall, on request, supply all relevant information and documents including budgetary
p.(None): documents, required to enable the Member State to verify compliance with Annex XI requirements.
p.(None):
p.(None): Article 17
p.(None): CE marking
p.(None):
p.(None): 1. Devices, other than devices which are custom-made or intended for clinical investigations, considered
p.(None): to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when
p.(None): they are placed on the market.
p.(None): 2. The CE marking of conformity, as shown in Annex XII, must appear in a visible, legible and
p.(None): indelible form on the device or its sterile pack, where practicable and appropriate, and on the
p.(None): instructions for use. Where applicable, the CE marking must also appear on the sales packaging.
p.(None): It shall be accompanied by the identification number of the notified body responsible for
p.(None): implementation of the procedures set out in Annexes II, IV, V and VI.
p.(None): 3. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with
p.(None): regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device,
p.(None): to the packaging or to the instruction leaflet accompanying the device provided that the
p.(None): visibility and legibility of the CE marking is not thereby reduced.
p.(None):
p.(None):
p.(None): Article 18
p.(None): Wrongly affixed CE marking
p.(None):
p.(None): Without prejudice to Article 8:
p.(None):
p.(None): 1993L0042
...
p.(None): 3. the following Article 9a is inserted after Article 9:
p.(None):
p.(None): ‘Article 9a
p.(None): 1. Where a Member State considers that the conformity of a device or family of devices should be
p.(None): established, by way of dero- gation from the provisions of Article 9, by applying solely one of the
p.(None): given procedures chosen from among those referred to in Article 9, it shall submit a duly substantiated request to the
p.(None): Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with
p.(None): the procedure referred to in Article 7
p.(None): (2) of Directive 93/42/EEC (*).
p.(None): 2. The Commission shall inform the Member States of the measures taken and, where appropriate,
p.(None): publish the relevant parts of these measures in the Official Journal of the European Commu- nities.
p.(None):
p.(None): (*) OJ No L 169, 12.7.1993, p. 1.’
p.(None):
p.(None): 4. Article 10 shall be amended as follows:
p.(None): — the following subparagraph shall be added to paragraph 2:
p.(None): ‘Member States may however authorize manufacturers to start the clinical investigations in question before the
p.(None): expiry of the 60- day period, provided that the Ethical Committee concerned has delivered a favourable
p.(None): opinion with respect to the investigation programme in question.’,
p.(None): — the following paragraph shall be inserted:
p.(None): ‘2a. The authorization referred to in the second subparagraph of paragraph 2 may be subject to
p.(None): approval by the competent authority.’;
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 24
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 5. the following is added to Article 14:
p.(None): ‘In the event of a decision as referred to in the previous paragraph the manufacturer, or his
p.(None): authorized representative established in the Community, shall have an opportunity to put forward his viewpoint
p.(None): in advance, unless such consultation is not possible because of the urgency of the measures to be
p.(None): taken.’
p.(None):
p.(None): Article 22
p.(None): Implementation, transitional provisions
p.(None):
p.(None): 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary
p.(None): to comply with this Directive not later than 1 July 1994. They shall immediately inform the Commission
p.(None): thereof.
p.(None): The Standing Committee referred to in Article 7 may assume its tasks from the date of notification (1)
p.(None): of this Directive. The Member States may take the measures referred to in Article 16 on notification of
p.(None): this Directive.
p.(None): When Member States adopt these provisions, these shall contain a reference to this Directive or
...
p.(None): with the intended use.
p.(None):
p.(None): 7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be
p.(None): considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is
p.(None): liable to act upon the body with action ancillary to that of the device, the quality, safety and
p.(None): usefulness of the substance must be verified by analogy with the methods specified in Annex I to
p.(None): Directive 2001/83/ EC.
p.(None): For the substances referred to in the first paragraph, the notified body shall, having verified the
p.(None): usefulness of the substance as part of the medical device and taking account of the intended purpose of
p.(None): the device, seek a scientific opinion from one of the competent authorities designated by the Member States or
p.(None): the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation
p.(None): (EC) No 726/2004 (1) on the quality and safety of the substance including the clinical benefit/risk profile
p.(None): of the incorporation of the substance into the device. When issuing its opinion, the competent
p.(None): authority or the EMEA shall take into account the manu- facturing process and the data related to the
p.(None): usefulness of incorporation of the substance into the device as determined by the notified body.
p.(None): Where a device incorporates, as an integral part, a human blood deri- vative, the notified body shall,
p.(None): having verified the usefulness of the substance as part of the medical device and taking into account
p.(None): the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through
p.(None): its committee, on the quality and safety of the substance including the clinical benefit/risk profile of
p.(None): the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall
p.(None): take into account the manufac- turing process and the data related to the usefulness of incorporation of the
p.(None): substance into the device as determined by the notified body.
p.(None): Where changes are made to an ancillary substance incorporated in a device, in particular related to its
p.(None): manufacturing process, the notified body shall be informed of the changes and shall consult the relevant
p.(None): medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm
p.(None): that the quality and safety of the ancillary substance are maintained. The competent authority
p.(None): shall take into account the data related to the usefulness of incorporation of the substance into the device
p.(None): as determined by the notified body, in
p.(None):
p.(None): (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying
p.(None): down Community procedures for the authorisation and super- vision of medicinal products for human and
p.(None): veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as
p.(None): last amended by Regu- lation (EC) No 1901/2006.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 27
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): order to ensure that the changes have no negative impact on the estab- lished benefit/risk profile of the
p.(None): addition of the substance in the medical device.
p.(None): When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained
p.(None): information on the ancillary substance, which could have an impact on the established benefit/risk profile
p.(None): of the addition of the substance in the medical device, it shall provide the notified body with advice,
p.(None): whether this information has an impact on the established benefit/risk profile of the addition of the
p.(None): substance in the medical device or not. The notified body shall take the updated scientific opinion
p.(None): into account in reconsidering its assessment of the conformity assessment procedure.
p.(None): 7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the
p.(None): risks posed by substances leaking from the device. Special attention shall be given to substances which
p.(None): are carci- nogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council
p.(None): Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative
p.(None): provisions relating to the classification, packaging and labelling of dangerous substances (1).
p.(None): If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids
p.(None): or other substances to or from the body, or devices intended for transport and storage of such body
...
p.(None): manufacturer.
p.(None): 3.2. Application of the quality system must ensure that the products conform to the provisions of this Directive
p.(None): which apply to them at every stage, from design to final inspection. All the elements, requirements and
p.(None): provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly
p.(None): manner in the form of written policies and procedures such as quality programmes, quality plans, quality
p.(None): manuals and quality records.
p.(None):
p.(None): It shall include in particular the corresponding documentation, data and records arising from the
p.(None): procedures referred to in point (c).
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 34
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): It shall include in particular an adequate description of:
p.(None): (a) the manufacturer's quality objectives;
p.(None): (b) the organization of the business and in particular:
p.(None): — the organizational structures, the responsibilities of the managerial staff and their organizational
p.(None): authority where quality of design and manufacture of the products is concerned,
p.(None): — the methods of monitoring the efficient operation of the quality system and in particular its ability
p.(None): to achieve the desired quality of design and of product, including control of products which fail to
p.(None): conform,
p.(None):
p.(None): — where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried
p.(None): out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the
p.(None): type and extent of control applied to the third party;
p.(None): (c) the procedures for monitoring and verifying the design of the products, including the corresponding
p.(None): documentation, and in particular:
p.(None): — a general description of the product, including any variants planned, and its intended use(s),
p.(None): — the design specifications, including the standards which will be applied and the results of the risk
p.(None): analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply
p.(None): to the products if the standards referred to in Article 5 are not applied in full,
p.(None): — the techniques used to control and verify the design and the processes and systematic
p.(None): measures which will be used when the products are being designed,
p.(None): — if the device is to be connected to other device(s) in order to operate as intended, proof must be
p.(None): provided that it conforms to the essential requirements when connected to any such device(s) having the
...
p.(None): 4.1. In addition to the obligations imposed by Section 3, the manufacturer must lodge with the notified body an
p.(None): application for examination of the design dossier relating to the product which he plans to manufacture
p.(None): and which falls into the category referred to in Section 3.1.
p.(None): 4.2. The application must describe the design, manufacture and performances of the product in question. It must
p.(None): include the documents needed to assess whether the product conforms to the requirements of this
p.(None): Directive, as referred to in Section 3.2 (c).
p.(None): 4.3. The notified body must examine the application and, if the product conforms to the
p.(None): relevant provisions of this Directive, issue the application with an EC design-examination certificate. The
p.(None): notified body may require the application to be completed by further tests or proof to allow
p.(None): assessment of conformity with the requirements of the Directive. The certi- ficate must contain the conclusions of
p.(None): the examination, the conditions of validity, the data needed for identification of the approved design,
p.(None): where appropriate, a description of the intended purpose of the product.
p.(None):
p.(None): In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified
p.(None): body shall, as regards the aspects referred to in that section, consult one of the competent authorities
p.(None): designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a
p.(None): decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days
p.(None): after receipt of valid documentation. The scientific opinion of the competent national authority or the
p.(None): EMEA must be included in the documentation concerning the device. The notified body will give due
p.(None): consideration to the views expressed in this consultation when making its decision. It will convey its
p.(None): final decision to the competent body concerned.
p.(None): In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be
p.(None): included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after
p.(None): receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA
p.(None): when making its decision. The notified body may not deliver the certificate if the EMEA's scientific
p.(None): opinion is unfavourable. It will convey its final decision to the EMEA.
p.(None): In the case of devices manufactured utilising tissues of animal origin as referred to in Directive
p.(None): 2003/32/EC, the notified body must follow the procedures referred to in that Directive.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 36
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): 4.4. Changes to the approved design must receive further approval from the notified body which issued the
...
p.(None): 5.4.
p.(None): ▼M1
p.(None):
p.(None): ▼M5
p.(None):
p.(None): 7. Application to devices in Classes IIa and IIb.
p.(None): 7.1. In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb.
p.(None): Section 4, however, does not apply.
p.(None): 7.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section
p.(None): 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each
p.(None): device subca- tegory for compliance with the provisions of this Directive.
p.(None): 7.3. For devices in Class IIb the notified body shall assess, as part of the assessment in Section
p.(None): 3.3, the technical documentation as described in
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 37
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M2
p.(None):
p.(None):
p.(None): Section 3.2(c) for at least one representative sample for each generic device group for compliance with the
p.(None): provisions of this Directive.
p.(None): 7.4. In choosing representative sample(s) the notified body shall take into account the novelty of
p.(None): the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and
p.(None): the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties)
p.(None): that have been carried out in accordance with this Directive. The notified body shall document and keep
p.(None): available to the competent authority its rationale for the sample(s) taken.
p.(None): 7.5. Further samples shall be assessed by the notified body as part of the surveillance assessment
p.(None): referred to in Section 5.
p.(None):
p.(None): 8. Application to the devices referred to Article 1(4a)
p.(None): Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer
p.(None): shall inform the notified body of the release of the batch of devices and send to it the official certificate
p.(None): concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a
p.(None): laboratory designated for that purpose by a Member State in accordance with ►M5 Article 114(2) of
p.(None): Directive 2001/83/ EC ◄.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 38
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): ANNEX III
p.(None):
p.(None): EC TYPE-EXAMINATION
p.(None):
p.(None): 1. EC type-examination is the procedure whereby a notified body ascertains and certifies that a
p.(None): representative sample of the production covered fulfils the relevant provisions of this Directive.
p.(None): 2. The application includes:
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): conforms to the essential requirements when connected to any such device
p.(None): (s) having the characteristics specified by the manufacturer;
p.(None): 4.3. carry out or arrange for the appropriate inspections and the tests necessary to verify whether, if the
p.(None): manufacturer has chosen to apply the relevant standards, these have actually been applied;
p.(None): 4.4. agree with the applicant on the place where the necessary inspections and tests will be caried
p.(None): out.
p.(None): 5. If the type conforms to the provisions of this Directive, the notified body issues the applicant
p.(None): with an EC type-examination certificate. The certificate must contain the name and address of the manufacturer, the
p.(None): conclusions of the inspection, the conditions of validity and the data needed for identifi- cation of the
p.(None): type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept
p.(None): by the notified body.
p.(None):
p.(None): In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified
p.(None): body shall, as regards the aspects referred to in that section, consult one of the authorities
p.(None): designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a
p.(None): decision. The opinion of the competent national authority or the EMEA must be drawn up within 210 days after
p.(None): receipt of valid documen- tation. The scientific opinion of the competent national authority or the EMEA
p.(None): must be included in the documentation concerning the device. The notified body will give due
p.(None): consideration to the views expressed in this consultation when making its decision. It will convey its final
p.(None): decision to the competent body concerned.
p.(None): In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEA must be
p.(None): included in the documentation concerning the device. The opinion of the EMEA must be drawn up within 210 days after
p.(None): receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA
p.(None): when making its decision. The notified body may not deliver the certificate if the EMEA's scientific
p.(None): opinion is unfavourable. It will convey its final decision to the EMEA.
p.(None): In the case of devices manufactured utilising tissues of animal origin as referred to in Directive
p.(None): 2003/32/EC, the notified body must follow the procedures referred to in that Directive.
p.(None):
p.(None): 6. The applicant must inform the notified body which issued the EC type- examination certificate of
p.(None): any significant change made to the approved product.
p.(None): Changes to the approved product must receive further approval from the notified body which issued the EC
p.(None): type-examination certificate wherever the changes may affect conformity with the essential requirements or
...
p.(None): same type by the manufacturer.
p.(None): 3.2. Application of the quality system must ensure that the products conform to the type described in the EC
p.(None): type-examination certificate.
p.(None): All the elements, requirements and provisions adopted by the manufacturer for his quality system must be
p.(None): documented in a systematic and orderly manner in the form of written policy statements and procedures.
p.(None): This quality system documentation must permit uniform interpretation of the
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 43
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): quality policy and procedures such as quality programmes, plans, manuals and records.
p.(None): It must include in particular an adequate description of:
p.(None): (a) the manufacturer's quality objectives;
p.(None): (b) the organization of the business and in particular:
p.(None): — the organizational structures, the responsibilities of the managerial staff and their organizational
p.(None): authority where manufacture of the products is concerned,
p.(None):
p.(None): — the methods of monitoring the efficient operation of the quality system and in particular its ability
p.(None): to achieve the desired quality of product, including control of products which fail to conform,
p.(None):
p.(None):
p.(None): — where the manufacture and/or final inspection and testing of the products, or elements thereof, are
p.(None): carried out by a third party, the methods of monitoring the efficient operation of the quality system and in
p.(None): particular the type and extent of control applied to the third party;
p.(None):
p.(None):
p.(None): (c) the inspection and quality assurance techniques at the manufacturing stage and in particular:
p.(None): — the processes and procedures which will be used, particularly as regards sterilization, purchasing and
p.(None): the relevant documents,
p.(None): — the product identification procedures drawn up and kept up to date from drawings, specifications or other
p.(None): relevant documents at every stage of manufacture;
p.(None):
p.(None): (d) the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with
p.(None): which they will take place, and the test equipment used; it must be possible adequately to trace back
p.(None): the calibration of the test equipment.
p.(None):
p.(None): 3.3. The notified body must audit the quality system to determine whether it meets the requirements
p.(None): referred to in Section 3.2. It must presume that quality systems which implement the relevant
p.(None): harmonized standards conform to these requirements.
p.(None):
...
p.(None): ▼M1
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M2
p.(None):
p.(None): 6. Application to devices in Class IIa
p.(None): In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:
p.(None): 6.1. By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity
p.(None): the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with
p.(None): the technical documentation referred to in Section 3 of Annex VII and meet the requirements of
p.(None): this Directive which apply to them.
p.(None): 6.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section
p.(None): 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative
p.(None): sample for each device subcategory for compliance with the provisions of this Directive.
p.(None): 6.3. In choosing representative sample(s) the notified body shall take into account the novelty of
p.(None): the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and
p.(None): the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties)
p.(None): that have been carried out in accordance with this Directive. The notified body shall document and keep
p.(None): available to the competent authority its rationale for the sample(s) taken.
p.(None): 6.4. Further samples shall be assessed by the notified body as part of the surveillance assessment
p.(None): referred to in Section 4.3.
p.(None):
p.(None): 7. Application to devices referred to in Article 1(4a)
p.(None): Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer
p.(None): shall inform the notified body of the release of the batch of devices and send to it the official certificate
p.(None): concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a
p.(None): laboratory designated for that purpose by a Member State in accordance with ►M5 Article 114(2) of
p.(None): Directive 2001/83/ EC ◄.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 45
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): ANNEX VI
p.(None):
p.(None): EC DECLARATION OF CONFORMITY
p.(None):
p.(None): (Product quality assurance)
p.(None): 1. The manufacturer must ensure application of the quality system approved for the final inspection and
p.(None): testing of the product, as specified in Section 3 and must be subject to the surveillance referred to in
p.(None): Section 4.
p.(None): In addition, for products placed on the market in sterile condition, and only for those aspects of the
p.(None): manufacturing process designed to secure and maintain sterility, the manufacturer must apply the provisions
...
p.(None): — the decisions and reports from the notified body as referred to in the final indent of Section 3.4
p.(None): and in Sections 4.3 and 4.4,
p.(None): — where appropriate, the certificate of conformity referred to in Annex III.
p.(None): ▼M1
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None): 6. Application to devices in Class IIa
p.(None): In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:
p.(None): 6.1. By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity
p.(None): the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with
p.(None): the technical documentation referred to in Section 3 of Annex VII and meet the requirements of
p.(None): this Directive which apply to them.
p.(None): 6.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section
p.(None): 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative
p.(None): sample for each device subcategory for compliance with the provisions of this Directive.
p.(None): 6.3. In choosing representative sample(s) the notified body shall take into account the novelty of
p.(None): the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and
p.(None): the results of any previous relevant assessments (e.g. with regard to physical, chemical or biological properties)
p.(None): that have been carried out in accordance with this Directive. The notified body shall document and keep
p.(None): available to the competent authority its rationale for the sample(s) taken.
p.(None): 6.4. Further samples shall be assessed by the notified body as part of the surveillance assessment
p.(None): referred to in Section 4.3.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 48
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): ANNEX VII
p.(None):
p.(None): EC DECLARATION OF CONFORMITY
p.(None):
p.(None): 1. The EC declaration of conformity is the procedure whereby the manu- facturer or his authorised
p.(None): representative who fulfils the obligations imposed by Section 2 and, in the case of products placed
p.(None): on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5
p.(None): ensures and declares that the products concerned meet the provisions of this Directive which apply to
p.(None): them.
p.(None): 2. The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or
p.(None): his authorised representative must make this documentation, including the declaration of conformity, available
...
Orphaned Trigger Words
p.(None):
p.(None): ▼B
p.(None): this Directive; whereas, in this context, the safety, quality and usefulness of the substances
p.(None): must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20
p.(None): May 1975 on the approximation of the laws of the Member States relating to analytical,
p.(None): pharmaco-toxicological and clinical standards and protocols in respect of the testing of
p.(None): proprietary medicinal products (1);
p.(None): Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any
p.(None): reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of
p.(None): technology and practice existing at the time of design and of technical and economical considerations compatible with a
p.(None): high level of protection of health and safety;
p.(None): Whereas, in accordance with the principles set out in the Council reso- lution of 7 May 1985 concerning a
p.(None): new approach to technical harmo- nization and standardization (2), rules regarding the design and manu-
p.(None): facture of medical devices must be confined to the provisions required to meet the essential
p.(None): requirements; whereas, because they are essential, such requirements should replace the corresponding national
p.(None): provisions; whereas the essential requirements should be applied with discretion to take account of the
p.(None): technological level existing at the time of design and of technical and economic considerations compatible with
p.(None): a high level of protection of health and safety;
p.(None): Whereas Council Directive 90/385/EEC of 20 June 1990 on the approx- imation of the laws of the Member States relating
p.(None): to active implantable medical devices (3) is the first case of application of the new approach to the
p.(None): field of medical devices; whereas in the interest of uniform Community rules applicable to all medical
p.(None): devices, this Directive is based largely on the provisions of Directive 90/385/EEC; whereas for the same
p.(None): reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this
p.(None): Directive;
p.(None): Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas
p.(None): this Directive should contain specific rules on this subject with regard to Council Directive 89/336/ EEC
p.(None): of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic
p.(None): compatibility (4);
p.(None): Whereas this Directive should include requirements regarding the design and manufacture of devices emitting
p.(None): ionizing radiation; whereas this Directive does not affect the authorization required by Council
p.(None): Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards
p.(None): for the health protection of the general public and workers against the dangers of ionizing radiation (5), nor
p.(None): application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation
p.(None): protection of persons undergoing medical examination or treatment (6); whereas Council Directive
p.(None): 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the
p.(None): safety and health of workers at work (7) and the specific directives on the same subject should
p.(None): continue to apply;
p.(None): Whereas, in order to demonstrate conformity with the essential requirements and to enable
p.(None): conformity to be verified, it is desirable to have harmonized European standards to protect against the
p.(None): risks asso- ciated with the design, manufacture and packaging of medical devices;
p.(None):
p.(None): (1) OJ No L 147, 9.6.1975, p. 1. Directive as last amended by Directive 91/507/ EEC (OJ No L 270, 26.9.1991, p.
p.(None): 32).
p.(None): (2) OJ No C 136, 4.6.1985, p. 1.
p.(None): (3) OJ No L 189, 20.7.1990, p. 17.
p.(None): (4) OJ No L 139, 23.5.1989, p. 19. Directive as last amended by Directive 92/31/ EEC (OJ No L 126, 12.5.1992, p.
p.(None): 11).
p.(None): (5) OJ No L 246, 17.9.1980, p. 1. Directive as last amended by Directive 84/467/ Euratom (OJ No L 265, 5.10.1984,
p.(None): p. 4).
p.(None): (6) OJ No L 265, 5.10.1984, p. 1.
p.(None): (7) OJ No L 183, 29.6.1989, p. 1.
p.(None):
p.(None):
p.(None): 1993L0042 — EN — 11.10.2007 — 005.001 — 4
p.(None):
p.(None): ▼B
p.(None): whereas such harmonized European standards are drawn up by private- law bodies and should retain their
p.(None): status as non-mandatory texts; whereas, to this end, the European Committee for Standardization
p.(None): (CEN) and the European Committee for Electrotechnical Standardi- zation (Cenelec) are recognized as
p.(None): the competent bodies for the adoption of harmonized standards in accordance with the general
p.(None): guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984;
p.(None): Whereas, for the purpose of this Directive, a harmonized standard is a technical specification (European
p.(None): standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in
p.(None): accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision
...
p.(None): In selecting the most appropriate solutions, the manufacturer must apply the following principles in the
p.(None): following order:
p.(None): — eliminate or reduce risks as far as possible (inherently safe design and construction),
p.(None): — where appropriate take adequate protection measures including alarms if necessary, in relation to
p.(None): risks that cannot be eliminated,
p.(None): — inform users of the residual risks due to any shortcomings of the protection measures adopted.
p.(None): 3. The devices must achieve the performances intended by the manu- facturer and be designed,
p.(None): manufactured and packaged in such a way that they are suitable for one or more of the functions
p.(None): referred to in Article 1 (2) (a), as specified by the manufacturer.
p.(None): 4. The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely
p.(None): affected to such a degree that the clinical conditions and safety of the patients and, where applicable,
p.(None): of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device
p.(None): is subjected to the stresses which can occur during normal conditions of use.
p.(None): 5. The devices must be designed, manufactured and packed in such a way that their characteristics and
p.(None): performances during their intended use will not be adversely affected during transport and storage taking
p.(None): account of the instructions and information provided by the manu- facturer.
p.(None): 6. Any undesirable side-effect must constitute an acceptable risk when weighed against the
p.(None): performances intended.
p.(None):
p.(None): 6a. Demonstration of conformity with the essential requirements must include a clinical
p.(None): evaluation in accordance with Annex X.
p.(None):
p.(None): II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
p.(None): 7. Chemical, physical and biological properties
p.(None): 7.1. The devices must be designed and manufactured in such a way as to guarantee the
p.(None): characteristics and performances referred to in Section I on the ‘General requirements’. Particular
p.(None): attention must be paid to:
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 26
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): — the choice of materials used, particularly as regards toxicity and, where appropriate, flammability,
p.(None): — the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the
p.(None): intended purpose of the device,
p.(None):
p.(None): — where appropriate, the results of biophysical or modelling research whose validity has been demonstrated
p.(None): beforehand.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None): 7.2. The devices must be designed, manufactured and packed in such a way as to minimize the risk posed
p.(None): by contaminants and residues to the persons involved in the transport, storage and use of the devices
...
p.(None): Notified bodies shall retain information on the geographical origin of the animals.
p.(None): Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be
p.(None): carried out so as to provide optimal security. In particular safety with regard to viruses and other
p.(None): ►M5 transmissible ◄ agents must be addressed by implementation of validated methods of elimination or
p.(None): viral inactivation in the course of the manufacturing process.
p.(None): 8.3. Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable
p.(None): pack and/or according to appropriate procedures to ensure that they are sterile when placed on the
p.(None): market and remain sterile, under the storage and transport conditions laid down, until the protective
p.(None): packaging is damaged or opened.
p.(None):
p.(None): (1) OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European
p.(None): Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 28
p.(None):
p.(None): ▼B
p.(None): 8.4. Devices delivered in a sterile state must have been manufactured and sterilized by an
p.(None): appropriate, validated method.
p.(None):
p.(None): 8.5. Devices intended to be sterilized must be manufactured in appropriately controlled (e. g.
p.(None): environmental) conditions.
p.(None):
p.(None): 8.6. Packaging systems for non-sterile devices must keep the product without deterioration
p.(None): at the level of cleanliness stipulated and, if the devices are to be sterilized prior to use, minimize the risk
p.(None): of microbial contamination; the packaging system must be suitable taking account of the method of sterilization
p.(None): indicated by the manufacturer.
p.(None):
p.(None): 8.7. The packaging and/or label of the device must distinguish between identical or similar
p.(None): products sold in both sterile and non-sterile condition.
p.(None): 9. Construction and environmental properties
p.(None): 9.1. If the device is intended for use in combination with other devices or equipment, the whole
p.(None): combination, including the connection system must be safe and must not impair the specified performances
p.(None): of the devices. Any restrictions on use must be indicated on the label or in the instructions for use.
p.(None):
p.(None): 9.2. Devices must be designed and manufactured in such a way as to remove or minimize as far
p.(None): as is possible:
p.(None):
p.(None): — the risk of injury, in connection with their physical features, including the volume/pressure
p.(None): ratio, dimensional and where appro- priate ergonomic features,
p.(None):
p.(None): — risks connected with reasonably foreseeable environmental conditions, such as magnetic fields,
p.(None): external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure
p.(None): and acceleration,
p.(None):
p.(None): — the risks of reciprocal interference with other devices normally used in the investigations or for the
p.(None): treatment given,
p.(None):
p.(None): — risks arising where maintenance or calibration are not possible (as with implants), from ageing of
p.(None): materials used or loss of accuracy of any measuring or control mechanism.
...
p.(None): ▼B
p.(None):
p.(None):
p.(None): ANNEX VII
p.(None):
p.(None): EC DECLARATION OF CONFORMITY
p.(None):
p.(None): 1. The EC declaration of conformity is the procedure whereby the manu- facturer or his authorised
p.(None): representative who fulfils the obligations imposed by Section 2 and, in the case of products placed
p.(None): on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5
p.(None): ensures and declares that the products concerned meet the provisions of this Directive which apply to
p.(None): them.
p.(None): 2. The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or
p.(None): his authorised representative must make this documentation, including the declaration of conformity, available
p.(None): to the national authorities for inspection purposes for a period ending at least five years after the
p.(None): last product has been manufactured. In the case of implantable devices the period shall be at least 15
p.(None): years after the last product has been manufactured.
p.(None):
p.(None): 3. The technical documentation must allow assessment of the conformity of the product with the
p.(None): requirements of the Directive. It must include in particular:
p.(None):
p.(None): — a general description of the product, including any variants planned and its intended use(s),
p.(None):
p.(None): — design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits,
p.(None): etc.,
p.(None): — the descriptions and explanations necessary to understand the above- mentioned drawings and diagrams and
p.(None): the operations of the product,
p.(None): — the results of the risk analysis and a list of the standards referred to in Article 5, applied in full
p.(None): or in part, and descriptions of the solutions adopted to meet the essential requirements of the
p.(None): Directive if the standards referred to in Article 5 have not been applied in full,
p.(None):
p.(None): — in the case of products placed on the market in a sterile condition, description of the methods used
p.(None): and the validation report,
p.(None):
p.(None): — the results of the design calculations and of the inspections carried out, etc.; if the device is to be
p.(None): connected to other device(s) in order to operate as intended, proof must be provided that it conforms
p.(None): to the essential requirements when connected to any such device(s) having the characteristics specified by
p.(None): the manufacturer,
p.(None):
p.(None): — the solutions adopted as referred to in Annex I, Chapter I, Section 2,
p.(None): — the pre-clinical evaluation,
p.(None): — the clinical evaluation in accordance with Annex X,
p.(None):
p.(None): — the label and instructions for use.
p.(None):
p.(None): 4. The manufacturer shall institute and keep up to date a systematic procedure to review experience gained
p.(None): from devices in the post-production phase, including the provisions referred to in Annex X, and to
p.(None): implement appro- priate means to apply any necessary corrective actions, taking account of the nature and
p.(None): risks in relation to the product. He shall notify the competent authorities of the following incidents immediately
p.(None): on learning of them:
p.(None):
p.(None): (i) any malfunction or deterioration in the characteristics and/or performance of a device,
...
p.(None): This rule does not apply to products that are intended to clean medical devices other than contact
p.(None): lenses by means of physical action.
p.(None): 4.4. Rule 16
p.(None): ►M5 Devices ◄ specifically intended for recording of X-ray diagnostic images are in Class IIa.
p.(None): 4.5. Rule 17
p.(None): All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III except
p.(None): where such devices are intended to come into contact with intact skin only.
p.(None): 5. Rule 18
p.(None): By derogation from other rules, blood bags are in Class IIb.
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 57
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): ANNEX X
p.(None):
p.(None): CLINICAL EVALUATION
p.(None):
p.(None): 1. General provisions
p.(None):
p.(None): 1.1. As a general rule, confirmation of conformity with the requirements concerning the
p.(None): characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal
p.(None): conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the
p.(None): benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of
p.(None): this data, hereinafter referred to as ‘clinical evaluation’, where appropriate taking account of any relevant
p.(None): harmonised standards, must follow a defined and methodologically sound procedure based on:
p.(None): 1.1.1. Either a critical evaluation of the relevant scientific literature currently available relating to
p.(None): the safety, performance, design characteristics and intended purpose of the device, where:
p.(None): — there is demonstration of equivalence of the device to the device to which the data relates, and
p.(None): — the data adequately demonstrate compliance with the relevant essential requirements.
p.(None): 1.1.2. Or a critical evaluation of the results of all clinical investigations made.
p.(None): 1.1.3. Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.
p.(None): 1.1a In the case of implantable devices and devices in Class III clinical investigations shall be
p.(None): performed unless it is duly justified to rely on existing clinical data.
p.(None): 1.1b The clinical evaluation and its outcome shall be documented. This docu- mentation shall be included
p.(None): and/or fully referenced in the technical documentation of the device.
p.(None): 1.1c The clinical evaluation and its documentation must be actively updated with data obtained from the
p.(None): post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan
p.(None): for the device is not deemed necessary, this must be duly justified and docu- mented.
p.(None): 1.1d Where demonstration of conformity with essential requirements based on clinical data is not deemed
p.(None): appropriate, adequate justification for any such exclusion has to be given based on risk management
p.(None): output and under consideration of the specifics of the device/body interaction, the clinical performances
p.(None): intended and the claims of the manufacturer. Adequacy of demonstration of conformity with the essential
p.(None): requirements by performance evaluation, bench testing and pre-clinical evaluation alone has to be duly
p.(None): substantiated.
p.(None):
p.(None): 1.2. All the data must remain confidential, in accordance with the provisions of Article 20.
p.(None): 2. Clinical investigations
p.(None): 2.1. Objectives
p.(None): The objectives of clinical investigation are:
p.(None): — to verify that, under normal conditions of use, the performance of the devices conform to those referred to in
p.(None): Section 3 of Annex I, and
p.(None): — to determine any undesirable side-effects, under normal conditions of use, and assess whether they constitute
p.(None): risks when weighed against the intended performance of the device.
p.(None): 2.2. Ethical considerations
p.(None): ►M5 Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th
p.(None): World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly. ◄ It
p.(None): is mandatory that all measures relating to the protection
p.(None):
p.(None): 1993L0042
p.(None): — EN — 11.10.2007 — 005.001 — 58
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ▼M5
p.(None):
p.(None):
p.(None): ▼B
p.(None):
p.(None):
p.(None): of human subjects are carried out in the spirit of the Helsinki Declaration. This includes
p.(None): every step in the clinical investigation from first consideration of the need and justification of the study to
p.(None): publication of the results.
p.(None): 2.3. Methods
p.(None): 2.3.1. Clinical investigations must be performed on the basis of an appropriate plan of investigation
p.(None): reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute
p.(None): the manu- facturer's claims for the device; these investigations must include an adequate number of
p.(None): observations to guarantee the scientific validity of the conclusions.
p.(None): 2.3.2. The procedures used to perform the investigations must be appropriate to the device under examination.
p.(None): 2.3.3. Clinical investigations must be performed in circumstances similar to the normal conditions of use of
p.(None): the device.
p.(None): 2.3.4. All the appropriate features, including those involving the safety and performances of the device,
p.(None): and its effect on patients must be examined.
p.(None):
p.(None): 2.3.5. All serious adverse events must be fully recorded and immediately notified to all competent
p.(None): authorities of the Member States in which the clinical investigation is being performed.
p.(None):
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| authority | Relationship to Authority |
| children | Child |
| criminal | criminal |
| disabled | Mentally Disabled |
| education | education |
| emergencies | patients in emergency situations |
| family | Motherhood/Family |
| hazard | Natural Hazards |
| illness | Physically Disabled |
| influence | Drug Usage |
| injured | injured |
| language | Linguistic Proficiency |
| nation | stateless persons |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| pregnant | Pregnant |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| union | Trade Union Membership |
| usage | Drug Usage |
| vulnerability | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| influence | ['substance', 'usage'] |
| substance | ['influence', 'usage'] |
| usage | ['influence', 'substance'] |
Trigger Words
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input