Dan Lewis

Prrc Agreement

Remember that if you relocate the PRRC, this person must be qualified to deal with compliance with European medical device regulations. Finally, your PRRC is considered a critical supplier and you must have agreements. As part of your supplier qualification process, this also includes contractors or consultants who support your compliance efforts. When relocating your PRRC, consider the above provisions whereby person is responsible for compliance with procedures, technical documentation and post-market oversight obligations. Your outsourced PRRC must be permanently available to you and integrated into the organisation to meet the requirements of the EU MDR/IVDR. When a company has several producers (“legal”) under a single parent company, each company must designate its own PRRC. The instructions do not specify whether these multiple PRRC functions cannot be combined or distributed in the same category of people if manufacturers co-use a QMS or if this is implemented with quality agreements. However, I suppose it is possible. If you want to hire a consultant as a PRRC because your company employs less than 50 people and receives less than 10 million euros in sales, Easy Medical Device offers you a model agreement. Thank you for your spelling!! I was looking for some detailed information about PRRC – that really helped. I came especially to your blog because of your legal origin – you helped clarify one of PRRC`s main concerns which is responsibility.

As there is not much clarity in this area, I suppose it has to be done on a contractual basis (add the point of responsibility in the agreement between manufacturer-PRRC). But again, there is no clear idea of how EU rules will go about it. It is important to note that neither the MDR/IVDR nor the MDCG 2019-7 guide provide details on the practical effects of sustainable and ongoing availability. Therefore, it is recommended that EU manufacturers and representatives be conservative and that their external PRRC remain accessible 24/7 and have an official representative for absences. The contractual agreement with the PRRC should include its permanent and ongoing availability, including the qualification of the person concerned.