31 March 2021
Further to our recent webinar on the device registration process under the new UK regulatory framework, MHRA has asked us to share a point of clarification regarding UK Responsible Person registration.
MHRA has emphasised that companies wishing to register as the UK Responsible Person for a non-UK manufacturer must file the correct designation agreement and has noted that some companies are incorrectly referring to themselves as the EU Authorised Representative.
Where these applications are rejected, the company will be required to pay the £100 registration fee again to resubmit.
MHRA has indicated that the designation for a UK Responsible Person must contain the bullet pointed roles set out in their guidance, available via the link below.