Brexit—medical devices
Brexit—medical devices

The following IP guidance note provides comprehensive and up to date legal information covering:

  • Brexit—medical devices
  • Legislative framework for medical devices
  • Overview of Brexit implications on medical devices
  • Withdrawal Agreement scenario—the implementation period
  • No deal scenario—general considerations
  • CE marking and UKCA marking—no deal
  • Authorised representative—no deal
  • Notified Bodies—no deal
  • UK Responsible Person—no deal
  • Registration of devices—no deal
  • more

This Practice Note deals with the key issues that are likely to affect the medical devices sector as a result of the UK’s withdrawal from the EU. For considerations on the possible Brexit scenarios (ie leaving the EU with a withdrawal agreement in place or leaving without an agreement—a no deal Brexit), the respective roles of the EU and UK medicines regulators and the potential impact of Brexit on the fundamental aspects of the medicinal products regulatory framework, see Practice Note: Brexit—the regulation of medicinal products. For a discussion on the potential impact of Brexit on the life sciences sector more generally, including on clinical trials and funding, see Practice Note: Brexit—general implications for the life sciences sector.

Legislative framework for medical devices

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

  1. Directive 93/42/EEC (consolidated version 11.10.2007), the Medical Devices Directive (MDD)

  2. Directive 90/385/EEC (consolidated version 11.10.2007), the Medical Devices Directive (AIMDD)

  3. Directive 98/79/EC (consolidated version 11.01.2012), the In Vitro Diagnostic Medical Devices Directive (IVDD)

In the UK, the MD Directives are primarily implemented into national legislation by the Medical Devices Regulations 2002 (MDR 2002), SI 2002/618 (as amended).

However, the EU framework for medical devices is being reformed and the MD Directives will be replaced by two regulations:

  1. Regulation (EU) 2017/745 (consolidated version