United Kingdom

Devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, prior to the end of the transition period, gave effect in UK law to the directives listed below:

Directive 90/385/EEC on active implantable medical devices (EU AIMDD)

Directive 93/42/EEC on medical devices (EU MDD)

Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

This means that the Great Britain route to market and UKCA marking requirements are based on the requirements derived from the above EU legislation.

European Union

Legally Binding

Medical Device Regulation 2017/745

In Vitro Diagnostic Regulation 2017/746

Non-Binding (Voluntary)

List of MEDDEV Documents

International Medical Device Regulators Forum Documents

https://www.imdrf.org/documents

GHTF Documents

Medical Devices Post Market Surveillance: Content of Field Safety Notices