Hi,
We are a UK manufacturing company with our sister company designated as an Authorised Representative (MDD)following Brexit from 01 Jan 2021. I have few questions I am not sure of
- does Authroised Representative should be a person. Does this responsibility need to be included in the contract or with a Designation Letter for that person? Will this be required as proof when registering the devices with Competent authroity?
- The national requirement of Safety Officer- Can this person be based in the UK? Is this requirement still needed fromMay 2021 when PRRC is appointed? I read different views about this that if the company is not based in Germany then Safety Officer does not have to be appointed. Is this true? where can I find the requirmeents in English? Also after PRRC is appointed under MDR, is safety officer still needed?
- So for a UK company following Brexit, do they need to appoint
a) a person as an Authotised Representative
b) then safety Officer
c) PRRC/Responsible Person under MDR from May 2021
Does it really need all three people if the manufacturer in based in the UK? Any useful advise would be greatly appreciated.
We are a UK manufacturing company with our sister company designated as an Authorised Representative (MDD)following Brexit from 01 Jan 2021. I have few questions I am not sure of
- does Authroised Representative should be a person. Does this responsibility need to be included in the contract or with a Designation Letter for that person? Will this be required as proof when registering the devices with Competent authroity?
- The national requirement of Safety Officer- Can this person be based in the UK? Is this requirement still needed fromMay 2021 when PRRC is appointed? I read different views about this that if the company is not based in Germany then Safety Officer does not have to be appointed. Is this true? where can I find the requirmeents in English? Also after PRRC is appointed under MDR, is safety officer still needed?
- So for a UK company following Brexit, do they need to appoint
a) a person as an Authotised Representative
b) then safety Officer
c) PRRC/Responsible Person under MDR from May 2021
Does it really need all three people if the manufacturer in based in the UK? Any useful advise would be greatly appreciated.