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. Contact us to discuss what a PRRC partnership would look like for your company.

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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.

Biotop fulfils the PRRC role

Team PRRC

Biotop’s PRRC team shares the knowledge of your files, so continuity is maintained even if someone is unavailable or moves into a different role. You always have a qualified PRRC available through Biotop, without depending on one individual.

Our PRRC responsibilities

Device release

Before a batch of devices is released, Biotop verifies that your manufacturing and quality procedures were followed. That verification happens promptly, so release is not delayed on our end.

Technical documentation

Biotop reviews your technical documentation against the MDR and IVDR’s general safety and performance requirements, and flags what’s missing before it becomes a problem during an audit.

Declaration of conformity

A declaration of conformity can only be signed once your PRRC has verified that the device meets the applicable requirements. Biotop carries out that verification and helps you prepare a declaration that withstands scrutiny.

Post-market surveillance

Once a device is on the market, Biotop monitors how it performs on your behalf. Biotop helps you set up post-market surveillance that captures meaningful data, and makes sure that data is actually reviewed, not just filed.

Reporting obligations

Vigilance and incident reporting fall under your PRRC’s responsibility. Biotop helps you recognise what needs to be reported and handles communication with the competent authorities, so reporting deadlines are met.

Grounded in Article 15

These responsibilities follow from Article 15 of the MDR and IVDR. Biotop supports you across the PRRC role, your technical documentation and your quality management system, so the pieces fit together instead of being handled separately.

Services

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

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.

Do our manufacturer and our EU authorised representative need separate PRRCs?

A manufacturer and its EU authorised representative each need their own PRRC, the two roles cannot be fulfilled by the same person. Biotop can take on the PRRC role for either party, or for both at once through separate team members, so the requirement is met on both sides without extra coordination on your end.

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.

How does Biotop meet the 'permanently and continuously available' requirement for the PRRC role?

Article 15 requires manufacturers without an in-house PRRC to have one permanently and continuously available. A single external consultant can struggle to guarantee that during holidays or absence. Biotop’s PRRC team shares knowledge across your files, so that availability requirement is met by design, not by relying on one person’s schedule.