The regulation of medical devices in the UK

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • The regulation of medical devices in the UK
  • Regulatory framework for medical devices
  • Medical Devices Regulations 2002 as amended
  • EU-UK Trade and Cooperation Agreement
  • EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
  • Medicines and Medical Devices Act 2021
  • Guidance
  • MHRA and British Standard Institute roles
  • Overview of the regulatory regime
  • Key requirements for placing a medical device on the Great Britain market
  • More...

The regulation of medical devices in the UK

This Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the key steps for placing a medical device on the market in Great Britain (GB) and Northern Ireland (NI) and introduces the concepts of UK Conformity Assessed (UKCA) and UKNI markings, UK Approved Bodies and UK Responsible Person.

Regulatory framework for medical devices

Medical Devices Regulations 2002 as amended

The UK regulatory framework for medical devices originates from EU directives (for information on the EU regulatory framework for medical devices, see Practice Note: An introduction to the regulation of medical devices—EU Directives regime—Legislative framework).

The Medical Devices Regulations 2002 (MDR 2002), SI 2002/618 (as amended) implemented:

  1. Directive 93/42/EEC (consolidated version 11.10.2007) on medical devices (MDD)

  2. Directive 90/385/EEC (consolidated version 11.10.2007) on active implantable medical devices (AIMDD)

  3. Directive 98/79/EC (consolidated version 11.01.2012) on in vitro diagnostic medical devices (IVDD)

As a consequence of Brexit, the body of EU-derived laws has been preserved and converted into UK domestic law with effect on IP completion day (11 pm on 31 December 2020). For further information on retained EU law, see Practice Note: Introduction to retained EU law. In addition, under the Ireland/Northern Ireland Protocol (the Protocol), NI is subject to EU requirements governing medical devices.

To this end, MDR 2002 have been amended by:

  1. the Medical Devices (Amendment etc) (EU Exit)

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