EU MDR & IVDR PRRC: Qualifications & Responsibilities
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Define qualified PRRC coverage under MDR and IVDR, including the micro and small enterprise availability exception and the separate authorized representative obligations.
Video guide
EU PRRC: Article 15 Requirements
Understand the PRRC role under EU MDR and IVDR Article 15, including qualifications and responsibilities.
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Who can be your PRRC for the EU? Article 15 of the MDR and IVDR requires one for every manufacturer and every authorized representative. And not just anyone qualifies. Start with company size. Among manufacturers, only micro and small enterprises, under 50 staff and up to 10 million euros, may use an outside PRRC under contract. Medium and large manufacturers need one inside their own organization, as an employee. The person must be qualified: a degree in law, medicine, pharmacy, engineering or another relevant science, plus one year of regulatory or quality experience with medical devices. Or four years of that experience. Outside the EU, you need two different people. MDCG guidance says your PRRC and your authorized representative's PRRC cannot be the same person, even within one group. Start with three things. One: check your company size. Two: keep proof of your PRRC's degree and experience. Three: register the PRRC in EUDAMED and update any change within a week. The right person, on record. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.
What is a Person Responsible for Regulatory Compliance?
Under MDR or IVDR Article 15, the PRRC is the qualified person available to a manufacturer or Authorized Representative. The role provides defined regulatory oversight; appointing a person does not transfer all legal responsibilities away from the organization.
Use the MDR, IVDR and MDCG 2019-7 revision 1 to assess the arrangement for each legal manufacturer and representative.
Internal PRRC versus external availability
| Organization | Article 15 arrangement | Practical control |
|---|---|---|
| Manufacturer outside the micro/small exception | At least one PRRC available within the organization | Defined authority, competence and integration into QMS processes |
| Qualifying micro or small manufacturer | May have the PRRC permanently and continuously at its disposal rather than within the organization | Written availability, access, continuity and escalation arrangements |
| Authorized Representative | Qualified PRRC permanently and continuously at its disposal | Preserve the AR’s separate duties and independence |
The exception is for micro and small enterprises under the referenced EU recommendation, not every business commonly called an SME. Medium-sized manufacturers cannot assume they qualify. Outsourcing an activity also does not remove the legal manufacturer’s accountability.
Qualifications and responsibilities
The general qualification routes combine a relevant recognized diploma or degree with at least one year of relevant regulatory-affairs or quality-system experience, or at least four years of relevant professional experience. Article 15 contains a specific qualification provision for custom-made-device manufacturers. Document the actual evidence of competence for the device and regulation, rather than relying only on a job title.
Manufacturer PRRC responsibilities include ensuring the appropriate conformity checks before release, current technical documentation and Declaration of Conformity, PMS obligations, required reporting and the applicable investigational-device statement. Link each responsibility to a controlled procedure and record.
| Responsibility | Evidence of an operating arrangement |
|---|---|
| Release conformity | Defined checks or sampling within the QMS and escalation of failures |
| Documentation | Controlled GSPR evidence map, technical file and declaration updates |
| PMS and vigilance | Access to signals, report decisions and PSUR/PMS outputs |
| Availability | Backup, absence coverage, authority and communication routes |
Keep manufacturer and representative roles distinct
The manufacturer’s PRRC and AR PRRC support different legal obligations. Do not assume that naming the same external consultant in both positions is acceptable; assess the independence and conflict concerns identified in the MDCG guidance. If responsibilities are shared among multiple people, define the respective areas in writing.
Keep applicable EUDAMED actor information current, with access and personnel changes controlled. Review the arrangement when organization size, product range, responsibilities or personnel change. Pure Global can assess the eligibility and scope of an external PRRC arrangement and help document the interfaces with the manufacturer’s QMS.
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Plan your device registration, local representation and ongoing compliance with Pure Global.
Frequently asked questions
No. Article 15’s exception applies to qualifying micro and small enterprises, not automatically medium-sized companies. Assess the EU enterprise definition and maintain permanent and continuous access to a qualified person.
No. The AR is a distinct economic operator appointed under a written mandate. The PRRC is a qualified person performing the Article 15 oversight role for the relevant organization.
Yes, where the respective areas of responsibility are stipulated in writing. Maintain suitable competence, access, continuity and escalation across the combined arrangement, including personnel-change and absence controls.
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