An introduction to the regulation of medical devices
Produced in partnership with Hogan Lovells International LLP Jane Summerfield, Elisabethann Wright, Fabien Roy
An introduction to the regulation of medical devices

The following Life Sciences guidance note Produced in partnership with Hogan Lovells International LLP Jane Summerfield, Elisabethann Wright, Fabien Roy provides comprehensive and up to date legal information covering:

  • An introduction to the regulation of medical devices
  • Legislative framework
  • Reform of the EU framework
  • Overview of the regulatory regime
  • The steps to placing a medical device on the market
  • What is a medical device?
  • Classification of medical devices
  • Essential requirements
  • Conformity assessment and Notified Bodies
  • Conformity assessment procedures
  • more

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

Legislative framework

In the EU, the current regulatory framework for medical devices consists of three Directives (the MD Directives):

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

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

  3. Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices (IVDD)

together with various amending legislation, including Directive 2007/47/EC.

Directives must be implemented in each EU Member State through national legislation. In the UK, the MD Directives are primarily implemented into national legislation by the Medical Devices Regulations 2002, SI 2002/618 (as amended). The UK competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA).

The MD Directives are also applicable to the EEA countries of Iceland, Liechtenstein