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.