| 12.7.93 | Official Journal of the European Communities | No L 169 |
| ANNEX
II EC DECLARATION OF CONFORMITY (Full quality assurance system) |
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| 1. | The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the products concerned, as specified in Section 3 and is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5 | ||
| 2. | The declaration
of conformity is the procedure whereby the manufacturer
who fulfils the obligations imposed by Section 1 ensures
and declares that the products concerned meet the
provisions of this Directive which apply to them. The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover a given number of the products manufactured and be kept by the manufacturer. |
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| 3. | Quality system | ||
| 3.1. | The manufacturer
must lodge an application for assessment of his quality
system with a notified body. The application must include: |
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| — | the name and address of the manufacturer and any additional manufacturing site covered by the quality systems, | ||
| — | all the relevant information an the product or product category covered by the procedure, | ||
| — | a written declaration that no application has been lodged with any other notified body for the same product-related quality system, | ||
| — | the documentation on the quality system, | ||
| — | an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved, | ||
| — | an undertaking by the manufacturer to keep the approved quality system adequate and efficacious, | ||
| — | an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them: | ||
| (i) | any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might (lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; | ||
| (ii) | any technical or medical reason connected with the characteristics or performance of a device leading for the reasons referred to in subparagraph (i) to systematic recall of devices of the same type by the manufacturer. | ||
| 3.2. | Application of
the quality system must ensure that the products conform
to the provisions of this Directive which apply to them
at every stage, from design to final inspection. All the
elements, requirements and provisions adopted by the
manufacturer for his quality system must be documented in
a systematic and orderly manner in the form of written
policies and procedures such as quality programmes,
quality plans, quality manuals and quality records. It shall include in particular an adequate description of: |
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| (a) | the manufacturer's quality objectives; | ||
| (b) | the organisation of the business and in particular: | ||
| — | the organizational structures the responsibilities of the managerial staff and their organizational authority where quality of design and manufacture of the products is concerned, | ||
| — | the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of design and of product, including control of products which fail to conform; | ||
| (c) | the procedures for monitoring and verifying the design of the products and in particular: | ||
| — | a general description of the product, including any variants planned, | ||
| — | the design specifications, including the standards which will he applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full, | ||
| — | the techniques used to control and verify the design and the processes and systematic measures which will he used when the products are being designed, | ||
| — | if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer, | ||
| — | a statement indicating whether or not the device incorporates, as an integral part, a substance as referred to in Section 7.4 of Annex I and data on the tests conducted in this connection, | ||
| — | the clinical data referred to in Annex X, | ||
| — | the draft label and, where appropriate, instructions for use; | ||
| (d) | the inspection and quality assurance techniques at the manufacturing stage and in particular: | ||
| — | the processes and procedures which will he used, particularly as regards sterilization, purchasing and the relevant documents, | ||
| — | the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture; | ||
| (e) | the appropriate tests and trials which will be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible to trace back the calibration of the test equipment adequately. | ||
| 3.3. | The notified
body must audit the quality system to determine whether
it meets the requirements referred to in Section 3.2. It
must presume that quality Systems which implement the
relevant harmonized standards conform to these
requirements. The assessment team must include at least one number with past experience of assessments of the technology concerned. The assessment procedure must include an inspection on the manufacturer's premises and in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes. The decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment. |
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| 3.4. | The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment. | ||
| 4. | Examination of the design of the product | ||
| 4.1. | In addition to the obligations imposed by Section 3, the manufacturer must lodge with the notified body an application for examination of the design dossier relating to the product which he plans to manufacture and which falls into the category referred to in Section 3.1. | ||
| 4.2. | The application must describe the design, manufacture and performances of the product in question. It must include the documents needed to assess whether the product conforms to the requirements of this Directive, as referred to in Section 3.2 (c). | ||
| 4.3. | The notified
body must examine the application and, if the product
conforms to the relevant provisions of this Directive,
issue the application with an EC design-examination
certificate. The notified body may require the
application to be completed by further tests or proof to
allow assessment of conformity with the requirements of
the Directive. The certificate must contain the
conclusions of the examination, the conditions of
validity, the data needed for identification of the
approved design, where appropriate, a description of the
intended purpose of the product. In the case of devices referred to in Annex I, paragraph 7.4, the notified body shall, in view of the aspects addressed in that paragraph, consult one of the competent bodies established by the Member States in accordance with Directive 65/65/EECN before taking a decision. The notified body will give due consideration to the views expressed in this consultation when making its decision. It will convey its final decision to the competent body concerned. |
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| 4.4. | Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product. The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design. This additional approval must take the form of a supplement to the EC design-examination certificate. | ||
| 5. | Surveillance | ||
| 5.1. | The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality system. | ||
| 5.2. | The manufacturer must authorize the notified body to carry out all the necessary inspections and supply it with all relevant information, in particular: | ||
| — | the documentation on the quality system, | ||
| — | the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculation tests, etc., | ||
| — | the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. | ||
| 5.3. | The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system and must supply the manufacturer with an assessment report. | ||
| 5.4. | In addition, the notified body may pay unannounced visits to the manufacturer. At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report. | ||
| 6. | Administrative provisions | ||
| 6.1 | The manufacturer must, for a period ending at least five years after the last product has been manufactured, keep at the disposal of the national authorities: | ||
| — | the declaration of conformity, | ||
| — | the documentation referred to in the fourth indent of Section 3.1, | ||
| — | the changes referred to in Section 3.4, | ||
| — | the documentation referred to in Section 4.2, and | ||
| — | the decisions and reports from the notified body as referred to in Sections 3.3, 4.3, 4.4, 5.3 and 5.4. | ||
| 6.2. | The notified body must make available to the other notified bodies and the competent authority, on request, all relevant information concerning quality system approvals issued, refused or withdrawn. | ||
| 6.3. | In respect of devices subject to the procedure in Section 4, when neither the manufacturer nor his authorized representative is established in the Community, the obligation to keep available the technical documentation shall fall to the person responsible for placing the device on the Community market or the importer referred to in Annex I, Section 13.3 (a). | ||
| 7. | Application to
devices in Classes IIa and IIb In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4, however, does not apply. |
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