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)
International Medical Device Regulators Forum Documents
https://www.imdrf.org/documents
GHTF Documents
Medical Devices Post Market Surveillance: Content of Field Safety Notices
List of Standards for Applicable to Medical Devices
ISO 14971: 2019
Medical Device - Post-market surveillance for manufacturers ISO/TR 20416: 2020