Medical Device Regulation in Great Britain and Northern Ireland

As the end of the Brexit transition draws near, MHRA recently published guidance on how medical devices will be regulated in the GB (England, Scotland and Wales) and Northern Ireland markets. In our earlier post on this guidance, we outlined the apparent advantage for GB market access for medical devices manufactured and CE marked in Northern Ireland after the date of application of the GB’s new medical device regulations on the 30-Jun-2023. In addition, there are changes to the requirements for UK and EU representatives. 
 
EC Rep (Authorised Representative) and UK Responsible Person services can be provided by companies located in Northern Ireland after the end of the Brexit transition. In addition, GB-based manufacturers must appoint an EU or NI-based Authorised Representative in order to place their medical devices on the NI market. 
 
ARC Regulatory is currently offering Authorised Representative and UK Responsible Person services to global and GB manufacturers in order to continue to place devices on the GB, NI and EU markets beyond the end of the transition (for the EU/NI market) and the grace periods in the MHRA guidance (for the GB market). 

Get in touch to discuss how we can support you through this unprecedented transition period.