MDR Article 15 · IVDR Article 15 · MDCG 2019-7 Rev.1
Person responsible for regulatory compliance in the EU
A PRRC is not a ceremonial name on an organisation chart. The role provides defined regulatory oversight across device release, technical documentation, post-market surveillance, vigilance and investigational devices or performance studies.
Article 15 applies to manufacturers placing devices on the Union market and to authorised representatives of non-EU manufacturers. The appointment model depends on the legal entity, enterprise size and the role being performed.
Purpose of the role
Regulatory control without transferring the manufacturer’s responsibility
The PRRC has a key role in verifying that relevant regulatory processes work. The manufacturer must involve the PRRC in the processes needed for the role and provide access to necessary information, including identified nonconformities.
The manufacturer nevertheless remains responsible for demonstrating device conformity. Appointing a PRRC does not transfer legal manufacturer obligations, replace management accountability or turn one individual into the entire regulatory and quality function.
Verify
Check that defined processes and evidence are applied before release.
Connect
Link technical documentation, PMS, vigilance and change control.
Escalate
Raise regulatory gaps and inability to fulfil Article 15 duties.
Document
Leave a traceable record of oversight, decisions and follow-up.
Appointment model
First identify the legal entity and its role
“Manufacturer”, “authorised representative” and “group company” are not interchangeable. Article 15 applies at legal-entity level, and every legal manufacturer must be covered by its own compliant appointment.
Model 01
Manufacturer that is not micro or small
At least one qualified PRRC must be available within the organisation. MDCG 2019-7 Rev.1 interprets this as an employee of the legal manufacturer.
- Relationship
- Within the organisation
- Typical evidence
- Employment, role description and authority
Model 02
Micro or small manufacturer
The PRRC does not have to be within the organisation. An external person may be used when the manufacturer documents permanent and continuous availability and the practical means to perform the duties.
- Relationship
- Internal or contracted external PRRC
- Typical evidence
- Contract, availability and operating procedure
Model 03
Authorised representative
The authorised representative must have a qualified PRRC permanently and continuously at its disposal. The role may be subcontracted if the arrangement and availability are adequately documented.
- Relationship
- Internal or contracted external PRRC
- Focus
- Fulfilment of the authorised representative’s mandate
Location and separation
Keep the PRRC close enough to exercise real oversight
The location expectations below come from MDCG guidance and support the required permanent and continuous link. They are not a substitute for assessing the actual organisation, manufacturing activities and mandate.
PRRC in the Union market
MDCG guidance assumes that the PRRC of an EU manufacturer should also be located in the Union market.
PRRC near manufacturing activities
The guidance assumes a location outside the Union and recommends physical and geographical proximity to manufacturing.
PRRC in the Union market
The authorised representative’s PRRC is expected to be located in the Union market so the mandate can be overseen effectively.
The PRRC of a non-EU manufacturer and the PRRC of its authorised representative cannot be the same individual. For a micro or small manufacturer, the two PRRCs must not belong to the same external organisation.
Requisite expertise
Two qualification routes, supported by evidence
The manufacturer or authorised representative must retain evidence showing that the named person is qualified and capable of performing the assigned role.
Recognised formal qualification
A university degree or equivalent course of study in law, medicine, pharmacy, engineering or another relevant scientific discipline
+At least one year of professional experience in regulatory affairs or quality management systems relating to devices
Professional experience
At least four years of professional experience in regulatory affairs or quality management systems relating to medical devices or IVDs
Relevant, substantive and recent
Experience should relate to EU requirements and enable the person to perform the duties effectively. Administrative document handling or shadowing alone is insufficient.
Non-EU qualifications
A qualification obtained outside the EU should be recognised as equivalent by one EU Member State. Keep the recognition evidence with the appointment record.
MDR custom-made-device route
Subject to national provisions, a manufacturer of custom-made devices may demonstrate expertise through at least two years of relevant manufacturing experience.
Minimum responsibilities
Article 15 duties must be built into working procedures
The Regulation states minimum areas of responsibility. The operating model must translate them into access rights, review points, records, escalation routes and named process owners.
Before release
Conformity checks under the QMS
Ensure that device conformity is appropriately checked under the quality management system before release. This may use audits or risk-based sampling, but the check must address substance, not merely document presence.
Controlled evidence
Technical documentation and declaration
Ensure that the technical documentation and EU declaration of conformity are drawn up and kept current, including when product or process changes affect the evidence.
Lifecycle feedback
Post-market surveillance
Ensure compliance with PMS obligations and verify that the system collects and evaluates information needed to maintain device safety and performance.
Regulatory reporting
Vigilance obligations
Ensure that applicable reporting obligations are fulfilled, including serious incidents, field safety corrective actions and trend reporting.
Clinical or performance studies
Required study statement
For investigational devices and relevant IVD performance studies, ensure issuance of the statement required by MDR Annex XV or IVDR Annex XIV.
Two distinct controls
Manufacturer PRRC and authorised representative PRRC are not the same role
A non-EU manufacturer and its EU authorised representative each need their own regulatory control. Combining them would remove the intended second level of scrutiny.
| Control point | Manufacturer’s PRRC | Authorised representative’s PRRC |
|---|---|---|
| Primary basis | Article 15(1)–(5) | Article 15(6) and the AR mandate |
| Core focus | Manufacturer processes, device release and lifecycle compliance | Fulfilment of the authorised representative’s tasks under Article 11(3) |
| Location expectation | Close link with manufacturing activities | Located in the Union market |
| Can be the same person | No, for a non-EU manufacturer and its authorised representative | |
| Can share one external organisation | No, where the manufacturer is micro or small and uses an external PRRC | |
The PRRC must not suffer disadvantage within the manufacturer’s organisation for properly fulfilling the role, whether or not the person is an employee. Independence requires authority to raise issues and a documented management response.
EUDAMED actor information
Record the PRRC details and keep them current
The PRRC is not registered as a separate economic operator. Instead, the manufacturer or authorised representative records the PRRC’s name, address and contact details within its own actor information.
The Actor Registration module is among the first four EUDAMED modules whose use became mandatory.
Update changed PRRC information, including a replacement or terminated contract, within one week.
Appointment readiness
What a defensible PRRC arrangement should contain
A name and CV are only the starting point. The appointment should show how the person can actually exercise oversight across the relevant device lifecycle.
Legal-entity scope
Every manufacturer and authorised representative covered by the appointment is identified.
Qualification file
Diplomas, recognition evidence, CV and substantive recent experience support the selected route.
Written responsibilities
Article 15 duties and any division between multiple PRRCs are stipulated in writing.
Information access
The PRRC can obtain controlled documentation, PMS data, complaints, changes and nonconformities.
Availability and continuity
Response expectations, leave coverage, deputy arrangements and urgent escalation are workable.
Review records
Checks, findings, decisions, management responses and closure evidence are retained.
Protection from disadvantage
The governance model permits independent escalation without retaliation for proper performance.
EUDAMED maintenance
PRRC contact details are current and a process exists to update changes within one week.
Primary sources
Check the appointment against the law and current guidance
Article 15 establishes the obligation. MDCG 2019-7 Rev.1 explains how the European authorities expect key concepts to operate in practice.
Regulation (EU) 2017/745
MDR Article 15 and related manufacturer obligations
Regulation (EU) 2017/746
IVDR Article 15 and related manufacturer obligations
MDCG 2019-7 Rev.1
Guidance on the PRRC role, revised December 2023
EUDAMED actor registration
Current European Commission information and documentation
In brief
Questions about the PRRC role
Does every manufacturer need a PRRC?
Manufacturers placing devices on the Union market must have at least one qualified PRRC. Micro and small manufacturers may use an external person, but must have that person permanently and continuously at their disposal.
Can a larger manufacturer appoint an external consultant as its only PRRC?
Not under the MDCG interpretation of “within their organisation”. A manufacturer that is not micro or small is expected to appoint an employee of the legal manufacturer. External support may supplement, but not replace, that internal appointment.
Must an external PRRC be available 24 hours every day?
No. The arrangement must allow the PRRC to perform operational duties and react in a timely manner. The contract should define realistic availability, urgent escalation and continuity.
Can several people share PRRC responsibilities?
Yes. Their respective areas of responsibility must be stipulated in writing and, together, cover the required Article 15 responsibilities.
Can one group PRRC cover several legal manufacturers?
Each legal manufacturer must have its own PRRC arrangement. The same qualified person may potentially support more than one entity only where each appointment independently meets the legal, availability, location and capacity requirements.
What changes must be made in EUDAMED when the PRRC changes?
The actor information should be updated with the new PRRC name, address and contact details within one week. Internal appointment and access records should be updated at the same time.
From appointment to evidence
Make the PRRC role operational, not nominal
MDRC can review your appointment model, verify qualifications, define the oversight procedure and provide external PRRC support for eligible organisations.