Person Responsible for Regulatory Compliance

Fulfilling your PRRC obligation under MDR and IVDR

Let us take on your PRRC role

We can act as your external PRRC or support your existing team, covering device release, technical documentation, declarations of conformity, post-market surveillance and reporting obligations. Contact us to discuss what a PRRC partnership would look like for your company.

Contact us

Finding someone in-house who meets the PRRC requirements under the MDR and IVDR isn’t easy, especially if your company has fewer than 50 employees. Biotop Medical’s regulatory team can take on that role for you: we handle device release, technical documentation, your declaration of conformity, post-market surveillance and reporting obligations.

Whether you’d rather hand it over completely, get support alongside your own team, or just want advice when it counts, we fit around how you work.

PRRC consultancy services

Team PRRC

You’re never dependent on a single person. Our PRRC team shares the knowledge of your files, so someone is always available, even when a team member is on holiday or leaves the company.

Device release

Before a batch of devices leaves the building, the PRRC checks that your manufacturing and quality procedures were actually followed. We carry out that check, so release doesn’t sit and wait on us.

Technical documentation

Your PRRC has to confirm that your technical documentation meets the MDR and IVDR’s general safety and performance requirements. We review your technical documentation and flag what’s missing before it becomes a problem during an audit.

Declaration of conformity

A declaration of conformity can only be signed once the PRRC has verified the device actually meets what’s required. We do that verification and help you prepare a declaration that holds up.

Post-market surveillance

Once a device is on the market, the PRRC keeps an eye on how it performs. We help you set up post-market surveillance that actually captures useful data, and make sure that data gets reviewed instead of filed away.

Reporting obligations

Vigilance and incident reporting fall under the PRRC’s responsibility. We help you recognise what needs to be reported and handle communication with the competent authorities, so deadlines don’t slip.

Services

For direct contact call
+31 (0)71 528 01 12
Questions? Contact us
info@biotopmedical.nl

Article 15

Article 15 of the MDR and the IVDR is where the PRRC role actually comes from. It sets out who needs one, what qualifications count, and what the PRRC is responsible for. It’s also where the exemption sits for manufacturers with fewer than 50 employees, so you can bring in an external PRRC instead of hiring one yourself.

The PRRC role leans heavily on two other things being in order: your technical documentation and your quality management system. We can support you across all three, so the pieces actually fit together instead of being handled separately.

FAQ about the PRRC role

What is a PRRC?

A PRRC (Person Responsible for Regulatory Compliance) is the person a medical device or IVD manufacturer has to appoint under Article 15 of the MDR and IVDR. They’re responsible for making sure your technical documentation, conformity assessment, post-market surveillance and reporting obligations actually meet the regulation.

What are the PRRC requirements?

Article 15 asks for a relevant degree, such as law, medicine, pharmacy or engineering, combined with a year of hands-on experience in medical devices or quality management systems. Without a matching degree, four years of professional experience in regulatory affairs or QMS for medical devices also qualifies.

Can one PRRC work for more than one manufacturer?

Yes, an external PRRC such as Biotop Medical can fulfil the role for multiple manufacturers at the same time, as long as they can genuinely meet the responsibilities for each one.

What is Article 15?

Article 15 is the article in the MDR and IVDR that introduces the PRRC requirement itself. It covers who needs one, what they need to be qualified, and what they’re responsible for. It also contains the exemption that lets manufacturers with fewer than 50 employees appoint an external PRRC.

Does a PRRC need to be registered in EUDAMED?

Yes, the PRRC’s details need to be registered as part of your manufacturer registration in EUDAMED, the EU database for medical devices.

Is a PRRC required under both the MDR and the IVDR?

Yes. Both the Medical Device Regulation and the In Vitro Diagnostic Regulation include the PRRC requirement in their Article 15, so manufacturers under either regulation need one.