The PRRC conundrum
Article 15 of the MDR and IVDR require a legal manufacturer or authorized representative to appoint a PRRC. This is a person who is supposed to be responsible for regulatory compliance. Obviously, the CEO or general manager of the company should have the ultimate responsibility for compliance, even if that is delegated to the QA/RA manager. So what does the PRRC have to add…?
Communicate a regulatory opinion
MDCG guidance 2019-7 about the PRRC is not informative about those responsibilities, but it would make sense if the PRRC is the official source of advice on compliance for management. At the November 2023 TEAM PRRC Summit an MDCG representative explained the main objective of Article 15 is to ensure there is at least one person within the organization with sufficient knowledge and experience regarding compliance who is able form a valid regulatory opinion. The PRRC must be able to collect information and formally share that opinion with management. Later, upper management may have to justify how they followed up on that opinion.
Notified body expectations
Notified bodies have not yet published guidance on how they want to see the role of the PRRC covered. But from the first audit results, it is possible to get an understanding of what they are expecting: they are looking for someone with expertise and experience in the field in which the company is acting and they must be able to perform their role independently. They are also looking for written evidence these expectations are met.
Organizing the role
To ensure the PRRC is in a position they can collect evidence and inform management, the appointment letter is important and the notified body also wants to see a justification for the individual who is appointed. It is also important to cover that role in a procedure that is part of the quality management system. It would make sense for the PRRC to have an annual plan, which will allow management to anticipate. Even if ‘nothing’ happened, the PRRC should report. ‘Nothing’ is also a result. And if something unexpected comes up, the PRRC should report on that, outside the annual plan.
Templates
To organize that role PRRCs would benefit from template forms that are fit for this I developed the following templates:
- Justification for the PRRC
- Initial assessment template
- PRRC appointment letter
- PRRC procedure
- PRRC annual plan
- PRRC annual report
- PRRC interim report
Four different types of PRRC
A PRRC may work for a manufacturer or an authorized representative and they may be in-house or outsourced. That results in four types of PRRC. Although they will have much in common, I think there are crucial differences in the details that require specific attention. The PRRC training will therefore be split up for these roles. The body of the training will for each type of PRRC be the same, the differences will be in the templates and the examples used.
Setup of the training
The training consists of two online sessions of two hours each with one week between them. That week can be used for homework. Where the first session is focusing on how to use the templates, the second session will focus on how these have been used by the students. Students can also book additional one-on-one coaching time to help them set up their role in detail if they want to. At the end of the training, students will get a certificate showing their participation.
Costs and organization
Additional personal coaching
For PRRCs that want additional personal training, there is the option of booking this together with their training. They can use this coaching budget to set up their role. For most PRRCs 2-5 hours will be adequate.
Planned training sessions
In-house manufacturer PRRC:
| Date and time | availability |
| 6 and 13 December 16:00 – 18:00 CET (limited to 8 participants) | Booked full |
| 28 February and 7 March 2023 19:00 – 21:00 CET (limited to 10 participants) | Open |
| 18 and 25 April 2023 10:00 – 12:00 CET (limited to 10 participants) | Open |
Outsourced manufacturer PRRC
| Date and time | availability |
| 7 and 14 February 2023 10:00 – 12:00 CET (limited to 10 participants) | Open |
| 16 and 23 May 2023 16:00 – 18:00 CET (limited to 10 participants) | Open |
In-house authorized representative PRRC
| Date and time | availability |
| 21 and 28 March 2023 10:00 – 12:00 CET (limited to 10 participants) | Open |
The other types of this training (authorized representative, outsourced) will soon be added to the agenda. Please let me know if you are interested in any of these and also in what time zone you are based (e.g. New Zealand, California).
More training
I will offer a two-day, in-person training for PRRCs in 2023. This training will focus on personal PRRC skills and challenge their judgment in critical situations. Watch this space for more information.
Please let me know if I can help you with anything else: ronald@boumansconsulting.com
