1. UK medical device law – Current picture

Last Updated on 06/11/2025 by Sarah Sarsby

Medical devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No. 618, or UK MDR)[1]. This secondary legislation translated into UK law the 1990 EU Active Implantable Medical Devices Directive (EU AIMDD), 1993 EU Medical Device Directive (EU MDD), and 1998 EU In Vitro Diagnostic medical device Directive (EU IVDD). Following Brexit, UK MDR has gone through a series of amendments.

EU MDD and EU AIMDD were superseded by the 2017 EU Medical Device Regulation 2017/745, or EU MDR, while EU IVDD was superseded by the 2017 EU In Vitro Diagnostic medical device Regulation 2017/746, or EU IVDR. Because EU MDR and EU IVDR post-dated the Brexit transition period, it was not automatically retained in the UK, by the EU (Withdrawal) Act 2018.

However, the EU MDR and EU IVDR are still relevant to the UK. Market access for UK medical devices is governed by its application for both access to Northern Ireland (NI) and where the Conformité Européene (CE) mark is applied. Since 26 May 2021, the EU MDR has applied in the EU and NI as a consequence of the Windsor Framework Agreement (previously known as the Northern Ireland Protocol), while EU IVDR has applied in the EU and NI since 26 May 2022. The EU MDR and EU IVR also apply in Great Britain (GB) where a CE marked device is placed on the market (see Section 2).

[1] Pre-Brexit, this gives/gave effect in UK law to: 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).