Marketing medical devices in the post-Brexit era: Working with a UK Responsible Person (UKRP)
The UK's withdrawal from the European Union has major ramifications for medical device manufacturers, including in-country representation requirements for companies selling their devices in Great Britain. Manufacturers will have to appoint UK Responsible Persons (UKRP) rather than European Authorized Representatives to manage their device registration and compliance efforts in the UK.
Our new webinar will address:
- The current regulatory situation in Great Britain and Northern Ireland
- Appointing a UK Responsible Person
- Appointing an importer
- Registration requirements
- CE, UKCA and UKNI marking
This webinar will be presented by Ronald Boumans, a Senior Consultant for Regulatory Affairs, with specific Brexit expertise. Ronald represents Emergo in the European Association of Authorized Representatives (EAAR) and represents EAAR at the European Commission in Brussels. He has also helped founding the UKRP Association, an organization that represents UKRPs and has frequent meetings with the British competent authority, MHRA.
This webinar was recorded on `18 February 2021.
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