Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (c. 42)

ANNEX VI U.K. EC DECLARATION OF CONFORMITY(Product quality assurance)

3. Quality system U.K.

3.1. The manufacturer lodges an application for assessment of his quality system with a notified body. U.K.

The application must include:

• the name and address of the manufacturer,

• all the relevant information on the product or product category covered by the procedure,

• a written declaration specifying that no application has been lodged with any other notified body for the same products,

• 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,

• where appropriate, the technical documentation on the types approved and a copy of the EC type-examination certificates,

• [F1 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, including the provisions referred to in Annex X, 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 labelling or 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 the performance of a device for the reasons referred to in subparagraph (i) leading to a systematic recall of devices of the same type by the manufacturer.

Textual Amendments

F1 Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).

3.2. Under the quality system, each product or a representative sample of each batch is examined and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests are carried out to ensure that the products conform to the type described in the EC type-examination certificate and fulfil the provisions of this Directive which apply to them. All the elements, requirements and provisionsadopted by the manufacturer must be documented in a systematic and orderly manner in the form of written measures, procedures and instructions. This quality system documentation must permit uniform interpretation of the quality programmes, quality plans, quality manuals and quality records. U.K.

It must include in particular an adequate description of:

• the quality objectives and the organizational structure, responsibilities and powers of the managerial staff with regard to product quality,

• the examinations and tests that will be carried out after manufacture; it must be possible to trace back the calibration of the test equipment adequately,

• the methods of monitoring the efficient operation of the quality system,

• the quality records, such as reports concerning inspections, tests, calibration and the qualifications of the staff concerned, etc.[F2 ,]

• [F2 where the 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.]

Textual Amendments

F2 Inserted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).

The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility.

3.3. The notified body audits 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. U.K.

The assessment team must include at least one member 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 to inspect the manufacturing processes.

The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system. U.K.

The notified body must assess the changes proposed and verify whether after these changes the quality system will still meet the requirements referred to in Section 3.2.

After receiving the abovementioned information it must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.