The written scope identifies the PRRC and confirms the Article 15 qualification route and supporting evidence before signature.
PRRC role
Appoint CENIT as PRRC under EU MDR or IVDR.
For manufacturers and authorised representatives that need named Article 15 PRRC coverage. Before appointment, CENIT documents the named PRRC, qualification route, availability model, scoped duties, and responsibilities that remain with the company.
Appointment proof
A PRRC appointment should be defensible before it is signed.
A manufacturer is appointing a named person into a legally sensitive role. The written scope should make the qualification basis, availability model, contracting facts, and retained responsibilities clear before the role starts.
Permanent and continuous availability, communication model, expected response time, absence handling, escalation model, and practical coverage are documented.
Location, contracting entity, appointment date, scope start, termination route, insurance evidence where applicable, and retained company responsibilities are confirmed before signature.
Responsibility split
What moves to CENIT, and what stays with you.
CENIT can be appointed to hold defined PRRC responsibilities, but the manufacturer and other economic operators keep their own legal responsibilities.
Defined Article 15 PRRC duties, review routines, regulatory-compliance interfaces, availability model, escalation rules, and appointment evidence as agreed in writing.
Product conformity, QMS operation, technical documentation ownership, PMS execution, vigilance decisions, economic-operator duties, and business decisions unless separately scoped.
Scope
PRRC appointment starts with the role CENIT is being asked to assume.
The PRRC role is not just a name on a chart. Under MDR/IVDR Article 15, the role needs competence, availability, defined responsibilities, and working interfaces with the QMS, technical documentation, PMS, vigilance, and release controls.
Manufacturer or authorised representative context, company size, product type, markets, internal competence, and whether a contracted PRRC appointment is appropriate.
Documented PRRC duties, authority limits, reporting lines, escalation rules, QMS links, and responsibilities retained by the manufacturer.
Records showing that PRRC responsibilities are understood, assigned, available, and connected to technical and post-market processes.
Coverage
PRRC support areas.
PRRC support is scoped around Article 15 responsibilities, documentation access, availability, escalation rules, and interfaces with the manufacturer or authorised representative.
Article 15 assessment Review whether the organisation has appropriate PRRC coverage and how the role should be documented. Appointment model and agreement Define the PRRC appointment, communication routes, availability, decision limits, and company-side responsibilities. QMS and documentation interfaces Connect PRRC responsibilities to conformity checks, technical documentation, declarations, PMS, vigilance, and release controls. Evidence and readiness Prepare role descriptions, responsibility matrices, review records, audit evidence, and remediation actions.
MDR / IVDR Article 15
The role has to be available, competent, and connected to the system.
Manufacturers and authorised representatives need PRRC coverage under MDR/IVDR Article 15. Where CENIT is appointed as PRRC, the role, availability, interfaces, and retained company responsibilities need to be documented and workable.
PRRC role coverage linked to conformity checks, technical documentation, EU declarations, post-market surveillance, vigilance, and investigational-device obligations where relevant.
PRRC role coverage and interfaces for authorised representative duties, mandate boundaries, manufacturer communication, and EU regulatory documentation.
Article 15 recognises a relevant formal qualification with at least one year of regulatory or QMS experience, or four years of relevant regulatory or QMS experience.
Micro and small enterprises may use a PRRC outside the organisation, but the person must be permanently and continuously at their disposal.
If PRRC responsibilities are shared across more than one person, the respective areas of responsibility should be stated in writing.
Buyer situations
When external PRRC support is useful.
The question is rarely just whether a name can be assigned. The arrangement has to hold up under management review, AR review, audit pressure, and day-to-day regulatory work.
The company lacks a suitable internal PRRC and needs a contracted arrangement with documented competence, availability, and role boundaries.
A PRRC is already named, but the evidence, responsibility split, escalation route, or QMS interface is too loose for audit or AR review.
An internal PRRC is leaving, capacity is thin, or an audit is approaching and the company needs interim coverage without blurring accountability.
Interfaces
PRRC responsibilities sit across regulatory, quality, and post-market processes.
The role is most credible when it is connected to the processes and records that prove control. CENIT helps define those interfaces without turning the PRRC into an undefined catch-all role.
Technical documentation Review routines and evidence that technical documentation is maintained and linked to conformity obligations. Declarations and release controls Interfaces for EU declarations, conformity checks, batch or product release controls, and QMS records. PMS and vigilance Links to PMS, PMCF/PMPF where relevant, complaints, vigilance, trend reporting, and corrective action. Audit evidence Role descriptions, responsibility matrix, competence evidence, availability records, and review evidence.
Deliverables
PRRC role outputs.
Outputs should make the role clear enough for management, auditors, Notified Bodies, authorised representatives, and the PRRC to understand how the arrangement works.
Assessment of current PRRC coverage, competence, availability, interfaces, documentation, and practical gaps.
Clear mapping of PRRC duties, manufacturer responsibilities, AR interfaces, QMS owners, escalation routes, and records.
Role description, agreement inputs, competence evidence, review routines, meeting records, audit evidence, and remediation actions.
Boundaries
A PRRC appointment does not transfer manufacturer responsibility.
When CENIT assumes the scoped PRRC role, the appointment does not erase the legal responsibilities of the manufacturer, authorised representative, importer, distributor, or QMS process owners.
The manufacturer remains responsible for conformity, technical documentation, PMS, vigilance, QMS operation, and product decisions.
Authorised representative, importer, distributor, and legal-representative duties must be scoped separately and are not assumed through PRRC appointment.
Clinical evaluation, testing, cybersecurity, legal advice, QMS implementation, and submission writing may require separate scope.
Appointment path
From fit check to appointed PRRC.
No PRRC appointment starts until the fit, qualification route, scope, availability model, and retained company responsibilities are clear enough to document.
Company role, device or IVD type, markets, current arrangement, QMS state, technical documentation status, qualification route, and urgency.
Document named PRRC, assigned duties, boundaries, communication route, availability model, competence evidence, records, and interfaces.
The appointment starts only after written scope is signed and the agreed review routines, escalation rules, and evidence requirements are in place.
Next step
Clarify the PRRC appointment before responsibilities are assumed.
Share the company role, product type, markets, current PRRC arrangement, QMS status, technical documentation status, and the appointment basis that needs to be confirmed.