The Medical Device Directives and Their Impact on the Development and Manufacturing of Medical Implants

Abstract

The introduction of a legal framework for the supply of medical implants is discussed with reference to the Active Implantable Medical Device Directive and the Medical Device Directive. The definitions of medical device and manufacturer are discussed. The application of the Directives to device/drug combinations is considered. All implants must meet certain essential requirements to ensure that they do not harm the patient, clinician or any third party. For most implants this will be indicated on the product or its packaging by CE marking involving an independent organization called a Notified Body; the latter are appointed by the Competent Authority of the Member State. Devices are classified in proportion to the risk associated with them. The steps needed to be taken by manufacturers are outlined and the verification options discussed. The role of standards and the new approach to writing them in Europe is presented. After placing a product on the market, the manufacturer must set up a system of post-market surveillance, including a vigilance procedure, in order to monitor product performance. Individual Member States can exercise the safeguard clause when a product appears to have had the CE marking incorrectly applied.

Keywords

directives implants essential requirements classification verification

Get full access to this article

View all access options for this article.

References

Quality systems for implantable cardiac pacemakers 1990 Good manufacturing practice, Department of Health (HMSO).

Quality systems for orthopaedic implants 1990 Good manufacturing practice, Department of Health (HMSO).

Quality systems for sterile medical devices and surgical products 1990 Good manufacturing practice, Department of Health (HMSO).

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Commission of the European Communities, Off. J. Eur. Comm., 1990, L 189, p. 17.

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Commission of the European Communities, Off. J. Eur. Comm., 1993, L 169, p. 1.

Proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices. Commission of the European Communities, COM(95), 1995.

Statutory Instruments 1992, number 3146, Consumer Protection, The Active Implantable Medical Devices Regulations 1992 (HMSO).

Statutory Instruments 1994, number 3017, Consumer Protection, The Medical Devices Regulations 1994 (HMSO).

BS EN ISO 9001: 1994 Quality systems—model for quality assurance in design, development, production, installation and servicing (formerly BS 5750: Part 1) (British Standards Institution, London).

10.

EN 46001: 1996 Quality systems—Medical devices—Particular requirements for the application of EN ISO 9001 (CEN/CENELEC).

11.

BS EN ISO 9002: 1994 Quality systems—model for quality assurance in production, installation and servicing (formerly BS 5750: Part 2) (British Standards Institution, London).

12.

EN 46002: 1996 Quality systems—Medical devices—Particular requirements for the application of EN ISO 9002 (CEN/CENELEC).

13.

Withdrawn.

14.

The CE Marking, February 1995.

15.

The Vigilance System, Update on the Directives, February 1995.

16.

Conformity Assessment Procedures, February 1995.

17.

Pre-Clinical Assessment Procedures, the Product Registration Scheme, February 1995.

18.

The Notified Body, February 1995.

19.

The Competent Authority, February 1995.

20.

Information about the EC Medical Devices Directive, October 1994.

21.

The Citizen's Charter and Deregulation, a Code for Enforcement, February 1995.

22.

The Classification Rules, February 1995.

23.

EC and EFTA Member States, the EEA Agreement and the EC Medical Devices Directives, January 1995.

24.

Sale and Supply of in vitro Diagnostic Medical Devices, November 1994.

25.

Standards, November 1994.

26.

Compliance Cost Assessments, December 1994.

27.

The Medical Devices, Electromagnetic and Compatibility and Low Voltage Directives, May 1995.

28.

Information about the Packaging and Packaging Waste Directive, May 1995.

29.

Medical Devices and Medicinal Products, May 1995.

30.

Activities of Healthcare Establishments (In-house Manufacture) in the UK, June 1995. Medical Device Agency Competent Authority (UK) 1 EC Directives, Guidance notes for manufacturers on clinical investigations to be carried out in the UK. Medical Device Agency Competent Authority (UK) 3 EC Directives, Information for clinical investigators. Medical Device Agency Competent Authority (UK) 4 EC Directives, Pre-clinical assessment guidance for assessors. Medical Device Agency Competent Authority (UK) 5 EC Directives, Guidance on biocompatibility assessment. Medical Device Agency Competent Authority (UK) 7 EC Directives, Guidance notes for manufacturers of Class I medical devices. Medical Device Agency Competent Authority (UK) 8 EC Directives, Guidance notes for the registration of persons responsible for placing devices on the market. Medical Device Agency Competent Authority (UK) 11 EC Directives, The Medical Devices Regulations 1994, guidance notes for trading standards officers.

31.

Medical Device Agency Competent Authority (UK) 1 EC Directives, Guidance notes for manufacturers on clinical investigations to be carried out in the UK.

32.

Medical Device Agency Competent Authority (UK) 3 EC Directives, Information for clinical investigators.

33.

Medical Device Agency Competent Authority (UK) 4 EC Directives, Pre-clinical assessment guidance for assessors.

34.

Medical Device Agency Competent Authority (UK) 5 EC Directives, Guidance on biocompatibility assessment.

35.

Medical Device Agency Competent Authority (UK) 7 EC Directives, Guidance notes for manufactwers of Class I medical devices.

36.

Medical Device Agency Competent Authority (UK) 8 EC Directives, Guidance notes for the registration of persons responsible for placing devices on the market.

37.

Medical Device Agency Competent Authority (UK) 11 EC Directives, The Medical Devices Regulations 1994, guidance notes for trading standards oficers.