PRRC Service
under MDR and IVDR

What does PRRC mean?

The abbreviation PRRC stands for "Person Responsible for Regulatory Compliance" - the English-language term for "person responsible for regulatory compliance". The abbreviation is simply due to the fact that the German and English terms are long and extremely impractical in everyday language use. Other terms are Responsible Person or Qualified Person.

The Qualified Person is modelled on the pharmaceutical sector, as a similar role has existed there for some time. However, this term is therefore imprecise in relation to medical devices.

Nevertheless: All these terms or abbreviations refer to the person according to Article 15 of the MDR or IVDR.

What are the tasks of a PRRC?

The tasks are set out in detail in Article 15. We have provided an overview of this in a our blog posts - This also describes a possible implementation for each task.

So it is up to you how the role of the PRRC should be implemented in the company: Does the PRRC carry out all tasks itself or should it only supervise the implementation?

How does the cooperation work?

First, we discuss in a free e-meeting or telephone call how you envisage working with us as a PRRC. Ideally, this discussion will already determine how you envisage the implementation of the PRRC role. We will be on hand to advise you and work with you to find an individual and sensible solution. At this point, we will also talk about expected expenses.

We then draw up two contracts: An offer for settlement and a contract for appointment as PRRC. After both parties have signed the contracts, the cooperation can start as planned.

You can either do the registration in DMIDS / EUDAMED yourself or we can do it for you.

From now on, the responsible person provided by us can work at your company as agreed. The exact procedure is based on your wishes and the regulatory requirements.