• PRRC MDR - Person Responsible for Regulatory Compliance


  • PRRC IVDR - Person Responsible for Regulatory Compliance

    Customer satisfaction

  • External responsible person Article 15


Good reasons for our cooperation

  • We implement the role of the external PRRC pragmatically and efficiently in your company. So that the solution fits you perfectly!
  • You decide: Should we, as an external PRRC, build up your staff so that they can take on the role of PRRC themselves as quickly as possible? Or do you want a long-term cooperation?
  • Through external PRRCs, you have access to extensive regulatory expertise.
  • Communication with notified bodies or authorities is no problem for us, even in the event of a crisis.

Regulatory requirements are the rules of the game in medical technology. We are the right partner for your success!

Our services

thinqbetter provided external responsible persons for medical devices and IVDs.

Performing tasks

We can carry out the tasks described in Article 15 in your company as an external PRRC.

Monitoring the implementation

You perform the tasks on Article 15 - we monitor. This way saves you effort and is permissible!

Capacity building

As an external PRRC, we can train your staff to take on this role themselves in parallel with the tasks.


Table of contents

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.

Being responsible for a task does not necessarily mean carrying out the task yourself!

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.

  • external responsible person


  • thinqbetter as external PRRC

    Customer satisfaction

  • PRRC IVDR under EU 2017/746



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