Brexit at work
The aftermath of Brexit leaves the UK with "third country" status for the EU, its own marking scheme (UK Conformity Assessment or UKCA marking), and an unusual special arrangement for marketing medical devices and IVDs in Northern Ireland. This white paper helps to make sense of the complicated and evolving situation on the ground. Manufacturers and importers will learn what they need to do to continue marketing devices and how to pursue future opportunities under the EU-UK Trade Agreement. Covered here are cross-market arrangements in both directions (EU to UK and UK to EU), as well as information on accessing Northern Ireland from each market.
This white paper references the EU-UK Trade Agreement signed in December 2020 and the available guidance documents to provide a roadmap for marketing medical devices and IVDs in the UK post-Brexit.