The notified body will assess the presence of a PRRC. They may ask for the qualifications of the PRRC and a justification of how the role of the PRRC has been setup. See this tip of the week for more background. Below you can find a simple template for this justification, with some example texts provided:
PRRC justification
For the role of the PRRC [company] has decided to appoint [person 1], [person 2], […] as their PRRC’s.
- These PRRC’s [have each their own role/perform the same roles and responsibilities/are split in a lead PRRC and a deputy PRRC/or other arrangement].
- [PRRC 1, 2, …] has a university degree/PhD in […] and has worked in [quality management/regulatory affairs/clinical affairs] related to medical devices for a total of […] years, of which […] years for [company]. This qualification sufficiently covers the minimal requirements of Article 15(1)/15(6). [In the case of a university degree from a university that was not based in the EU] Article 15(1)/15(6) requires a qualification other than a relevant university degree to be recognized by the relevant Member State. MDCG guidance 2019-7 on the PRRC has an interpretation that requires all education to be recognized, and limits that authority to EU Member States, instead of EEA Member States. It appears the MDCG is introducing new legislation that has not gone through the normal legislative process.
- This PRRC is based in […] because that is the location where [process/production/etc.] has the most critical impact on the safety and performance of the device.
- The PRRC has access to all locations, documents and staff that have or could have an impact on the conformity of the device and all staff is instructed to cooperate with any request from the PRRC.
- The PRRC will report as needed to upper management, but at least once per year.
In case of appointing an external PRRC:
For the role of the PRRC [company] has decided to appoint an external consultant for [consultancy], because management is of the opinion that it is not possible to combine a sufficient level of expertise with staff being in a position independent enough to form an objective opinion.
- [External PRRC1, 2,…] has a university degree/PhD in […] and has worked in [quality management/regulatory affairs/clinical affairs] related to medical devices for a total of […] years, of which […] years for [company]. This qualification sufficiently covers the minimal requirements of Article 15(1)/15(6). [In the case of a university degree from a university that was not based in the EU] Article 15(1)/15(6) requires a qualification other than a relevant university degree to be recognized by the relevant Member State. MDCG guidance 2019-7 on the PRRC has an interpretation that requires all education to be recognized, and limits that authority to EU Member States, instead of EEA Member States. It appears the MDCG is introducing new legislation that has not gone through the normal legislative process.
- This PRRC is based in […] because that is the location where [process/production/etc.] has the most critical impact on the safety and performance of the device.
- The PRRC has access to all locations, documents and staff that have or could have an impact on the conformity of the device and all staff is instructed to cooperate with any request from the PRRC.
- The PRRC will report as needed to upper management, but at least once per year.
Justification of a deputy PRRC
[company] has decided to appoint a deputy PRRC to assist the leading PRRC in case of a situation where compliance could be challenged. The deputy PRRC can also temporarily fill in the role of the leading PRRC is that role becomes vacant, or in a situation where the leading PRRC is not able to fill their role.
- The deputy PRRC covers all aspects of the work of the leading PRRC and the deputy PRRC is updated by the leading PRRC as needed.
- The deputy PRRC will report to upper management independently of the leading PRRC at least annually. [for qualifications and justification of appointing an external PRRC, see above]
