Dear colleagues,
I have a question: a potential client, a non-EU start-up, asks as of which point they need to appoint a PRRC. Currently, they have no product on the market inside the EU. No authorised representative, no affiliate yet in the EU. They just start with ISO 13485 certification at there HQ / manufacturing site outside the EU. They are about to sign with a NB for conformity assessment. When do they have to show to the NB that under there QMS, there will have (or have installed already) the ER, the PRRC in Europe? And the PRRC in their manufacturing site ?
Thank you for any feedback,
Best regards,
Rainer Voelksen
info@voelksenra.com
Dear Rainer,
It depends on the NB, but I would tell you the sooner the better. Some NB will check existence of AR even before signing the conformity assessment agreement. On top of it, PRRC is not just "another requirement", it serves the specific purpose of manufacturers to conform with the regulatory requirements. This even more valid for a start-up whose staff might sometimes have no regulatory experience at all, and some regulatory requirements might apply even in the "pre-device phase". I hope it helps !
Dear Rainer,
From a legal point of view, I would say that when applying for the SRN, you must name the PRRC at the latest (at least in Germany).
Otherwise, I agree with Sandra's recommendation: the sooner, the better.