We have heard numerous stories from around the world containing mixed messages regarding who can be appointed the PRRC of a medical device manufacturer. The following will hopefully answer the basics and we will try to keep this short and to the point.
Does a manufacture need to appoint a PRRC?
Yes, all manufacturers must appoint a PRRC. The best approach is to appoint an employee within your organisation who takes on the responsibility of the activities of the PRRC. However, micro or small enterprises as defined in commission recommendation 2003/361 can outsource the activity of the PRRC, but they must remain permanently and continuously available to the manufacturer.
Where should the PRRC be located?
There is an expectation for there to be a close relationship between the manufacturer and the PRRC, it therefore makes sense for them to be located reasonably close to each other. However, the following can be used as a simple rule:
- For a medical device manufacturer located outside the EU, the PRRC is expected to also be located outside the EU.
- For a medical device manufacture who is based in the EU, the PRRC shall also be located in the EU.
Authorised Representatives, such as Advena must appoint their own PRRC, and this is completely separate from the manufacturers PRRC, the two roles are not connected.
It should also be noted that the PRRC of the Authorised Representative cannot also be appointed the PRRC of the manufacturer.
For a greater understanding we would recommend reading the following documents:
- Article 15 of the MDR/IVDR,
- MDCG 2017-7 Rev. 1 Guidance on Article 15 of the MDR/IVDR.
