Brexit at work: Placing medical devices and IVDs on the UK market

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.

​Related services:

• CE Mark Certification for Medical Devices
• Clinical Evaluation Reports (CER) for Medical Devices in Europe
• EU IVDR Gap Assessment and CE Transition for IVD Companies
• EU MDR compliance consulting for cosmetic and aesthetic products
• EU Medical Device Vigilance Reporting in Europe
• EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
• European Authorized Representative for Clinical Trials
• European Authorized Representative for Medical Device Companies
• European MDR 2017/745 Gap Assessment and CE Transition Strategy
• European Union Medical Device Classification
• In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
• IVD Certification and Registration to Obtain CE Marking in Europe
• Medical Device and IVD Emergency Use Routes in Europe
• Medical Device Technical File and Design Dossier for EU CE Marking
• Switzerland Representative for Medical Device Companies
• UKRP and Brexit consulting for medical device companies