Council Directive 93/42/EECDangos y teitl llawn

3. Quality system U.K.

3.1. The manufacturer must lodge 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 that no application has been lodged with any other notified body for the same products,

• the documentation on the quality system,

• an undertaking to fulfil the obligations imposed by the quality system is approved,

• an undertaking to maintain the practicability and effectiveness of the approved quality system,

• 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 performance of a device for the reasons referred to in subparagraph (i) above 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. Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate. U.K.

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 policy statements and procedures. This quality system documentation must permit uniform interpretation of the quality policy and procedures such as quality programmes, plans, manuals and records.

It must 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 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 product, including control of products which fail to conform[F1 ,]

• [F2 where 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;]

(c)

the inspection and quality assurance techniques at the manufacturing stage and in particular:

• the processes and procedures which will be 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;

(d)

the appropriate tests and trials to 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 adequately to trace back the calibration of the test equipment.

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).

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. 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 after the final inspection and 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 still meets the requirements referred to in Section 3.2.

After the abovementioned information has been received the decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.