EMERGO BY UL SUMMARY OF KEY POINTS:
- MHRA will take on responsibility for the UK market;
- The CE Mark remains valid in the UK and no label changes are foreseen for now;
- MDR and IVDR will be implemented in the UK in parallel with the EU
- Non-UK manufacturers placing devices on the UK market need to appoint a UK Responsible Person, a role similar to that of the European Authorized Representative
- The UK-based manufacturer or the UK Responsible Person must register the device in the UK.