UK Responsible Person
Since the UK is no longer a member of the EU, medical device manufacturers must now follow the UK’s medical device regulation in order to place medical devices on the UK market. One of the requirements is to appoint a UK Responsible Person, who is physically located within the UK.
The UK Responsible Person’s responsibilities are to act on behalf of the manufacturer to ensure all their responsibilities detailed within the amended UK MDR 2002 regulations are met. These include amongst other tasks to register devices prior to being placed on the UK market.
As a team of dedicated medical device regulatory professionals, i-CELLBIO Ltd can offer a UK Responsible Person Service from their registered offices in the UK.
For more information, please contact us...