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1. UK medical device law – Current picture

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EU MDD and EU AIMDD were superseded by the 2017 EU Medical Device Regulation 2017/745, or EU MDR, while EU IVDD was superseded by the 2017 EU In Vitro Diagnostic medical device Regulation 2017/746, or EU IVDR.  As EU MDR and EU IVDR post-dated the Brexit transition period, it was not automatically retained by the EU (Withdrawal) Act 2018 and does not/will not apply in GB (per the Medicines Healthcare products Regulatory Agency, or MHRA).  NB:  EU MDR and EU IVDR are still relevant to the UK; market access for UK medical devices (Section 2 below) is governed by its application. Since 26-May-21, EU MDR has applied in the EU and Northern Ireland (NI), while EU IVDR has applied in the EU and NI since 26-May-22.

[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).