To the Chairmen of all Multi-centre Research Ethics Committees and Local Research Ethics Committees in England, Scotland, Wales, Northern Ireland

June 2000

Dear Colleague

MEDICAL DEVICES REGULATIONS AND RESEARCH ETHICS COMMITTES

Background

A series of three Medical Devices Directives, regulating the safety and marketing of medical devices throughout the European Community, started to come into effect from 1 January 1993. These Directives will eventually replace existing national systems in each Member State.

The Active Implantable Medical Devices Regulations 1992 (SI No 3146), which covers all implantable powered devices e.g. pacemakers, and which implements the provisions of the Active Implantable Medical Devices Directive 90/385/EEC, came into effect on 1 January 1993. The Medical Devices Regulations 1994 (SI No 3017), which covers most other medical devices with the exception of In Vitro Diagnostics and which implements the provisions of the Medical Devices Directive (93/42/EEC) came into effect on 1 January 1995. The In Vitro Diagnostic Medical Devices Regulations 2000 (SI No 1315), which covers any equipment or reagent intended to be used in vitro for the examination of substances derived from the human body, came into effect in the UK on the 7th of June 2000.

Regulatory Procedures

Under the provisions of these Regulations, no medical device with (with the exception of custom-made devices) may be placed on the market in the EC without a CE marking. In order to obtain this marking, the manufacturer must go through a conformity assessment procedure to con-firm that the device in question complies with the relevant Essential Requirements relating to safety and performance.

In order to demonstrate this compliance satisfactorily, clinical data may be required, particularly in the case of higher risk devices.