Complete Quality Assurance System?

Council Directive 90/385/EEC
(5 September 2007)

ANNEX 2
EC DECLARATION OF CONFORMITY
(Complete quality assurance system)

1.   The manufacturer shall apply the quality system approved for the design, manufacture and final inspection of the products concerned as specified in sections 3 and 4 and shall be subject to EC surveillance as specified in section 5.

2.      The declaration of conformity is the procedure by means of which the manufacturer who satisfies the obligations of section 1 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.

The manufacturer or his authorized representative established within the Community shall affix the CE marking in accordance with Article 12 and shall draw up a written declaration of conformity.

This declaration shall cover one or more clearly identified devices by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.

The CE marking shall be accompanied by the identification number of the notified body responsible.

3.  Quality system
3.1.   The manufacturer shall make an application for evaluation of his quality system to a notified body.

The application shall include:

• all the appropriate items of information for the category of products manufacture of which is envisaged,
• the quality-system documentation,
• an undertaking to fulfil the obligations arising from the quality system as approved,
• an undertaking to maintain the approved quality system in such a way that it remains adequate and efficacious,
• an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.  The undertaking shall include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:

(i) any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or a deterioration in his state of health;

(ii) any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.

3.2.   The 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 controls.

All the elements, requirements and provisions adopted by the manufacturer for his quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c). 

It shall include in particular an adequate description of:

(a) the manufacturer’s quality objectives;

(b) the organization 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 the design and of the products, including control of products which do not conform,
• where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;

(c) the procedures for monitoring and verifying the design of the products and in particular:

• the design specifications, including the standards which will be applied and a description of the solutions adopted to fulfil the essential requirements which apply to the products when the standards referred to in Article 5 are not applied in full,
• the techniques of control and verification of the design, the processes and systematic actions which will be used when the products are being designed,
• a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
• the pre-clinical evaluation,
• the clinical evaluation referred to in Annex 7;

(d) the techniques of control and of quality assurance at the manufacturing stage and in particular:

• the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,
• 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 effected before, during and after production, the frequency with which they will take place, and the test equipment used.

3.3.   Without prejudice to Article 13 of this Directive, the notified body shall effect an audit of the quality system to determine whether it meets the requirements referred to in 3.2. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards.

The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. The evaluation procedure shall 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 shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation.

3.4.   The manufacturer shall inform the notified body which has approved the quality system of any plan to alter the quality system.

The notified body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation.

4. Examination of the design of the product
4.1.   In addition to the obligations incumbent on him under section 3, the manufacturer shall make 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 3.1.

4.2.   The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).

It shall include inter alia:

• the design specifications, including the standards which have been applied,
• the necessary proof of their appropriations, in particular where the standards referred to in Article 5 have not been applied in full. This proof must include the results of the appropriate tests carried out by the manufacturer or carried out under his responsibility,
• a statement as to whether or not the device incorporates, as an integral part, a substance as referred to in section 10 of Annex 1, whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted,
• the clinical evaluation referred to in Annex 7,
• the draft instruction leaflet.

4.3.   The notified body shall examine the application and, where the product complies with the relevant provisions of this Directive, shall issue the applicant with an EC design examination certificate. The notified body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Directive may be evaluated. The certificate shall contain the conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.

In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. 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.

In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device. The opinion shall be drawn up within 210 days after receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA’s scientific opinion is unfavourable. It will convey its final decision to the EMEA.

4.4.   The applicant shall inform the notified body which issued the EC design examination certificate of any modification made to the approved design. Modifications made to the approved design must obtain supplementary approval from the notified body which issued the EC design examination certificate where such modifications may affect conformity with the essential requirements of this Directive or the conditions prescribed for the use of the product. This supplementary approval shall be given in the form of an addendum to the EC design examination certificate.

5.  Surveillance
5.1.   The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality system.

5.2.   The manufacturer shall authorize the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular:

• the quality-system documentation,
• the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,
• the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardizations/calibrations and the qualifications of the staff concerned, etc.

5.3.   The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report.

5.4.   In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report.

6. Administrative provisions
6.1. For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:

• the declaration of conformity,
• the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
• the amendments referred to in Section 3.4,
• the documentation referred to in Section 4.2,
• the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.

6.2. On request, the notified body shall make available to the other notified bodies and the competent authority all relevant information on approvals of quality systems issued, refused or withdrawn.

7. Application to the devices referred to in Article 1(4a):

Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.