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.
The EU Medical Devices Regulation and EU in vitro Diagnostic Medical Devices Regulation:
Since 26 May 2021, the EU Medical Devices Regulation (Regulation 2017/745) (EU MDR) has applied in EU Member States and Northern Ireland. The in vitro Diagnostic Medical Devices Regulation (Regulation 2017/746) (EU IVDR) will apply in EU Member States and Northern Ireland from 26 May 2022. As these EU regulations did not take effect during the transition period, they were not EU law automatically retained by the EU (Withdrawal) Act 2018 and therefore do not and will not apply in Great Britain.
There is further information below on how devices that have already been registered with the MHRA under the EU MDR or the EU IVDR will be regulated.
Legislation that applies in Great Britain: