Hi,
I am struggling with the following:
The European Commission released one new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro Diagnostic Device Regulation (IVDR.
Under Article 15 of MDR and IVDR, it states that companies are required to have at least one employee responsible for regulatory compliance with a degree in law, medicine, pharmacy, engineering or another relevant scientific discipline and four years of relevant professional experience in quality management systems relating to medical devices.
As to the location of this PRRC [person responsible for regulatory compliance], it is important that a close linkage, of a permanent and continuous nature, is established between the PRRC and the manufacturing activities," the EC says.
My question: we are not a medical device manufacturer but, as a translation partner and third party supplier, partner with medical devices manufacturers, to translate and publish their IFUs and other patient facing materials. Hence my question: does the above requirement only apply to manufacturers or does this extend to third party service providers contracted by these medical device manufacturers for miscellaneous services?
Thank you for your response!