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

The application shall include:

• all appropriate information concerning the products which it is intended to manufacture,

• 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,

• where appropriate, the technical documentation relating to the approved type and a copy of the EC type-examination certificate,

• an undertaking by the manufacturer to institute and keep up-dated a F1post-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:

  1. (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;

  2. (ii)

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

Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate.

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 an adequate description of:

1. (a)

   the manufacturer's quality objectives;

2. (b)

   the organization of the business and in particular:

   • the organizational structures, the responsibilities of the managerial staff and their organizational authority where 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 qualityX1of the design and of the products, including control of products which do not conformF1,

   • F2where the manufacture and/or final inspection and testing of the products, or elements thereof, are 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;

3. (c)

   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;

4. (d)

   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.

Without prejudice to Article 13, 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.

The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation.

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