An introduction to the regulation of medical devices—EU Directives regime
Produced in partnership with Jane Summerfield of Hogan Lovells , Elisabethann Wright of Hogan Lovells and Fabien Roy of Hogan Lovells
An introduction to the regulation of medical devices—EU Directives regime

The following Life Sciences practice note produced in partnership with Jane Summerfield of Hogan Lovells, Elisabethann Wright of Hogan Lovells and Fabien Roy of Hogan Lovells provides comprehensive and up to date legal information covering:

  • An introduction to the regulation of medical devices—EU Directives regime
  • Legislative framework
  • Implications of Brexit
  • The Withdrawal Agreement
  • The EU-UK Trade and Cooperation Agreement
  • Reform of the EU framework
  • Overview of the regulatory regime
  • The steps to placing a medical device on the market
  • Medical devices placed on the EU-27 market before the end of the transition period
  • What is a medical device?
  • More...

An introduction to the regulation of medical devices—EU Directives regime

In the EU, medical devices are tightly regulated by laws that govern their safety and performance across their entire product lifetime, from to pre- to post-market. This Practice Note provides an overview of the regulatory framework set out by Directive 93/42/EEC on medical devices (MDD), Directive 90/385/EEC on active implantable medical devices (AIMDD), which were applicable until 25 May 2021, and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), which applies until 25 May 2022. It explains how devices are classified, assessed (by completion of a conformity assessment) and CE marked. This Practice Note also considers the advertising and promotion of medical devices, counterfeit medical devices, 3D printing and mobile health. This Practice Note should be read taking into consideration that the general concepts and steps to placing a device on the market as well as specific considerations on in vitro diagnostic medical devices (IVDs) are still valid in the EU.

For information on the UK regime for medical devices, which is based on the EU directives, see Practice Note: The regulation of medical devices in the UK.

Legislative framework

In the EU, the regulatory framework for medical devices and active implantable medical devices (AIMDs) consisted of:

  1. Directive 93/42/EEC, the MDD

  2. Directive 90/385/EEC, the AIMDD

In addition, Directive 98/79/EC, the IVDD governs IVDs until 25 May 2022.

Directives must be implemented in each EU Member

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