I have written about the PRRC before, when the MDCG PRRC guidelines came out earlier this year.
With more experience with the subject in the mean time and everybody working to understand the subject, I thought it was a good idea to revisit the subject. And another good reason was that I had to look into it again because of the presentation I did at the Q1 EU Medical Devices & Diagnostic Quality Management Conference in Frankfurt last week. If you were not there, you’ve missed a good conference with among other things interesting exchange of experiences on how the first notified body QMS audits have been and how to work with the economic operator requirements in your QMS.
Surveillance interest in PRRC implementation
Below is my contribution to the MDR and IVDR QMS discussion, regarding the PRRC. Interestingly experience with QMS audits for the MDR shows that notified bodies take a lot of interest in the PRRC and the way that function is embedded in the manufacturer’s QMS. I have heard that competent authorities see the PRRC as an important compliance promoting factor and that they have instructed notified bodies to pay specific attention to it. Thus, it is clear that everyone on the suveillance side expects a lot from the PRRC and wants to see manufacturers take this position seriously, which should be reflected in the way the position is implemented in the QMS.
PRRC = sort of DPO
I have personally found that one of the better models to use for implementation of the PRRC may actually not be the pharma QP/QPPV but rather the General Data Protection Regulation’s Data Protection Officer. The way that the GDPR provides that the DPO must be implemented in a company shows a lot of parallels with what the authorities seem to have in mind for the PRRC under the MDR and IVDR. Especially the connection between management and the DPO has created a lot of positive and much needed awareness in data processing companies. This is – in my view – what the authorities are looking for with the PRRC as well: an increase in compliance awareness culture.
Curious about the more detailed version? Take a look right here:
PRRC guidance to be ‘updated’
Interesting news is that the not super well drafted PRRC Guidance of the MDCG is now slated to be updated somewhere next year, according to the Commission’s rolling guidance forecast. We know by now how much timing is worth when it comes to development of guidance, so it may also be later. It shows in any event that the MDCG has realised that the guidance needs revision.
Work in progress
The PRRC is a work in progress, but nothing prevents companies to implement it as best as they can already. Be prepared to implement the PRRC as something more as a token function, because this is not what the notified bodies and authorities seem to be looking for.
In my view, the guidance from the MDCG is based on a very traditional perspective of medical device company, which very few clients still operate.
Most of our clients would welcome guidance on the liability of the individual acting as the PRRC. Even if this simply states that this is a matter for national implementing law .