EU – REGULATORY -

Brexit, Notified Bodies, and Medical Devices -

The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the absence of a deal, the European Union (EU) will no longer recognize UKbased notified bodies for CE-marking purposes.

Post-Brexit UK notified bodies will become UK “approved bodies” and be able to grant “UKCA” marks to compliant products, including medical devices. Currently some 40% of all CE-marked medical device products use UK notified bodies. For a limited time manufacturers can use the CE mark on EU-compliant products on the UK market although, post-Brexit, relevant UK products for export to the EU will continue to require CE marking awarded by EU-based notified bodies.