• UKRP-services
      The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person (UKRP) designated and registered at the MHRA, and take the responsibility for the product in the UK. The UKRP is the equivalent of an EU Authorised Representative. UK-based manufacturers need to appoint an EU Authorized Representative. UK comprises England, Scotland, and Wales. Northern Ireland is part of the UK, but…