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Regulatory roles · Medical devices and IVD · EU

An outsourced PRRC for your medical devices and IVDs

Medical Devices

Article 15 of Regulation (EU) 2017/745 (MDR) and of Regulation (EU) 2017/746 (IVDR) names a person responsible for regulatory compliance (PRRC). Where the manufacturer may use an outsourced PRRC under Article 15, we can be your outsourced PRRC. As an extension of that service, and only with it, we can also act as your European Authorised Representative.

What the role covers and who contracts it

What we do as your PRRC

  • An appointment agreement that makes us your outsourced PRRC.
  • Verification of production control.
  • Review of your technical documentation.
  • The post-market surveillance plan, and monitoring of incidents.
  • Management of your registration in the European database on medical devices (EUDAMED).

For which manufacturers. MDR and IVDR manufacturers that may use an outsourced PRRC under Article 15, including makers of software as a medical device, medical mobile apps and in vitro diagnostic medical devices (IVDs).

The European Authorised Representative. We offer it only together with the outsourced PRRC, never on its own.

Who contracts it. CRITICAL CATALYST - Health Consulting, Lda., Matosinhos, Portugal.

Portugal and the EU

CRITICAL CATALYST - Health Consulting, Lda., Matosinhos

Questions people ask

Is a PRRC the same as an EU or UK Responsible Person?

No. The PRRC is the device role under Article 15. The EU and UK Responsible Person are cosmetics roles. Both names contain "responsible person", which is why they get confused; the obligations are different.

Can we appoint you as Authorised Representative without the PRRC?

Not with us. We offer the Authorised Representative only as an extension of the outsourced PRRC.

We make software. Does the role apply to us?

If your software is a medical device, yes. Whether it is one, and in which class, comes first; for software, qualification follows the guidance MDCG 2019-11 of the Medical Device Coordination Group. See Qualification and classification.

What does the PRRC do after CE marking?

The role is continuing: it carries the post-market surveillance plan and incident monitoring while the device is on the market. See Post-market.

Will you understand our technology?

The device team works on software as a medical device and IVDs, and on the risk and quality standards behind them (EN ISO 14971, ISO 13485). One consultant's doctoral research is on AI-enabled device software.

Where this role sits

Outsourced PRRC: step 6 of 6 of the EU device route
  1. Qualification and classification
  2. Regulatory strategy and roadmap
  3. Evidence and technical documentation
  4. Notified Body and CE marking
  5. Registration and distribution
  6. Post-market and outsourced rolesThis role: outsourced PRRC
See the full route

Briefings tagged PRRC

EU

What is a PSUR under the MDR, and who needs one?

Class IIa, IIb and III devices need a periodic safety update report. How often, how to group devices, and where it goes while EUDAMED's vigilance module is pending.

What happens next

Our team replies to every enquiry and asks for the device, its class, the regulation (MDR or IVDR) and the date you are working to.

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