PRRC online starter training

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.

It is also important to understand how to end this role. Even if this is done in a friendly atmosphere, there are some things to consider. Those arrangements should also be adequate to handle situations where a PRRC decides to leave because of fundamental differences of opinion with the company about compliance.

Templates

To organize that role PRRCs would benefit from template forms that are fit for this I developed the following sets of templates, matching with the type of economic operator and if this is for the in-house or the outsourced PRRC:

• 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. Scenarios based on real-life experience of PRRCs will be discussed. which results in a very high yield of training experience. For that reason, the maximum group size is six students per session. At the end of the training, students will get a certificate showing their participation, plus a ‘Super PRRC’ T-shirt that can be used to show in the office who is the PRRC.

PRRC Scenario Event

Based on feedback from the first generation of trained PRRCs an interactive session has been developed in which more scenarios are discussed. Participants are invited to share their own experience or questions and these will be reworked into anonimous cases. Only high-level, general information, or even slightly distorted information, will be used in presenting the case. A certification of attendance is also issued.

Costs and organization

The online PRRC starter courses cost 595 Euros, 545 Euros for TEAM PRRC members. This includes the applicable templates. The training is provided in two sessions of two hours, one week apart. Between the sessions the students will have the opportunity to do some ‘homework’, which will be discussed in the second session.

The PRRC Scenarion Events cost 165 Euros, 135 Euros for TEAM PRRC members.

Planned training sessions

Manufacturer in-house PRRC:

Manufacturer Outsourced PRRC

Authorized representative in-house PRRC

PRRC Scenario Event

There is very limited demand for the outsourced PRRC role, so this is only offered if there is demand. If you have difficulties as a result of your time zone, just reach out.

For reserving your spot and for letting me know if I can help you with anything else: ronald@boumansconsulting.com