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.

3.2. 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.[F1 ,]

• [F1 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

F1 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.