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. MDCG guidance document 2019-7 Rev. 1 explains under what conditions someone can be appointed as a PRRC and it provides some information about what the PRRC is supposed to do. However, there is still a lot of practical information missing.

Mind the bus

Over the past years, we have seen how the position of the PRRC has evolved within companies. Not surprisingly, the PRRC has been used as the scapegoat by companies that got into trouble. Several PRRCs have been thrown in front of the bus by management under pressure.

The other way round also happened. Managers acting as the PRRC succeeded in hiding serious issues for quite some time until they dragged the whole company with them.

Avoiding these scenarios means that the role of the PRRC must be understood and organized well. Clear ‘rules of engagement’ enable the PRRC to address regulatory creep in an early stage.

The regulatory opinion

The PRRC should observe, form an opinion, and communicate about that. The training addresses all three items:

• There is a fundamental difference between the work of the PRRC and that of an auditor. The PRRC must use different techniques and look at compliance from a different perspective.
• The concept of the regulatory opinion is explored. An opinion is not a decision, and it is not about acting. However, a good opinion can guide management to take the right decisions.
• In the case of a serious issue, communication is key. A good PRRC will ensure it is possible to quickly determine who knew what and when. A good PRRC will also be able to assist in external communication to ensure it is effective and does not cause unnecessary damage to the reputation of the company.

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 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.

Feedback from students:

• I could listen to you much longer, great training. You have so much experience. Many thanks for all provided templates.
• The homework scenarios are really making you think. Good choice!
• It would be nice to have one more session with more scenarios.
• A very informative and engaging course. The discussion of real-world scenarios was helpful to increase my level of confidence.
• For me greatest learning was the clarity on the distinction between the role of PRRC and the conventional QA and RA roles in the company. I also like the interactive format with a small group of participants with different perspectives and how everyone got space to express themselves and contribute to the discussions. It was very well moderated.

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.

Planned training sessions

Manufacturer in-house PRRC:

Manufacturer Outsourced PRRC

Authorized representative in-house PRRC

There is very limited demand for the outsourced authorized representative 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