No-deal Brexit—medical devices
No-deal Brexit—medical devices

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

  • No-deal Brexit—medical devices
  • Legislative framework for medical devices
  • No-deal scenario—general considerations
  • CE marking and UKCA marking
  • Authorised representative
  • Notified Bodies
  • UK Responsible Person
  • Registration of devices
  • Labelling
  • Parallel import

As of exit day (31 January 2020) the UK is no longer an EU Member State. However, in accordance with the Withdrawal Agreement, the UK has entered an implementation period, during which it continues to be subject to EU law (for further information on the Withdrawal Agreement, see Practice Note: Brexit—introduction to the Withdrawal Agreement).

If the UK and the EU do not agree on the terms of their future relationship following the implementation period or where the UK regulatory system substantially diverges from that of the EU, considerations similar to those which would have been applicable in case the Withdrawal Agreement had not been reached may still be valid. This Practice Note, which is based on statutory instruments and guidance published before the UK and EU reached the Withdrawal Agreement, deals with key issues that are likely to affect the regulation of medical devices in a no-deal scenario. This Practice Note will be kept under review and updated as necessary.

For considerations on the impact of the Withdrawal Agreement on the life sciences sector, including the relevance of EU law to the sector, the respective roles of the EU and UK regulators, marketing authorisations, medical devices and clinical trials, see Practice Note: Brexit—implications of the Withdrawal Agreement for the life sciences sector. For a discussion on the possible effect of a