What does a PRRC do?
The PRRC is a formally defined regulatory function, not another name for general regulatory consulting. Under Article 15, the PRRC is at least responsible for ensuring that:
- The conformity of devices is appropriately checked before release in accordance with the manufacturer’s quality-management system
- The technical documentation and EU declaration of conformity are drawn up and kept up to date
- Post-market surveillance obligations are complied with
- Regulatory reporting obligations referred to in the applicable regulation are fulfilled
- Required statements relating to investigational devices or relevant performance studies are issued where applicable
Required inputs before appointment
- Company structure and manufacturer status
- Device or IVD portfolio
- Intended purpose and classification
- Regulatory status
- QMS status
- Technical documentation status
- PMS and vigilance processes
- Regulatory roles and responsibilities
- Current conformity assessment or Notified Body status
What Fabola does
We formalise the PRRC appointment and define its responsibilities in a procedure and responsibility matrix.
We then provide scheduled regulatory oversight, review relevant compliance activities and follow a defined escalation process. We remain available for agreed PRRC matters and hold periodic management or regulatory status reviews.
Deliverables
- Documented PRRC appointment
- Responsibility matrix
- Communication and escalation process
- Documented PRRC reviews
- Periodic regulatory compliance reporting
- Ongoing availability within the agreed service level
Price
PRRC Core
SEK 18,000 / month
Small manufacturer with a stable QMS, limited product portfolio and relatively low ongoing regulatory activity.
PRRC Active
SEK 25,000–35,000 / month
Typical startup or scaleup with regular regulatory activity, document review, PMS/vigilance oversight and active conformity-assessment preparation.
PRRC Intensive
SEK 45,000–55,000 / month
Manufacturer in active conformity assessment, major change, remediation, CAPA activity or frequent Notified Body interaction.
Initial due diligence and onboarding are scoped separately, normally from SEK 18,000. Regulatory project work outside the agreed PRRC scope is quoted separately rather than absorbed into the retainer.
All prices are in SEK and exclude VAT.
Delivery and start time
A PRRC appointment can normally begin within 1–2 weeks once due diligence has been completed, responsibilities have been agreed and the engagement has been formally established.
Completion point
PRRC is an ongoing regulatory function rather than a one-off project. The engagement continues for the agreed contractual period and ends through the defined handover and termination process.
Exclusions
- Acting as the manufacturer’s complete regulatory department
- Unlimited technical-documentation authoring
- Unlimited QMS implementation
- Clinical or performance evaluation writing unless separately commissioned
- Submission project management unless separately commissioned
- Operational vigilance case handling beyond the agreed PRRC oversight scope
If further work is needed
PRRC support continues for as long as the appointment runs, and does not depend on buying other services. For companies not yet ready for a PRRC appointment, common first steps are a classification and conformity pathway assessment or an MDR / IVDR readiness assessment.
Frequently asked questions
Does every medical device manufacturer need a PRRC?
MDR Article 15 and IVDR Article 15 require manufacturers to have available at least one PRRC with the required expertise. The organisational arrangement differs for qualifying micro and small enterprises, which may have the PRRC permanently and continuously at their disposal rather than within the organisation.
Can the PRRC be an external consultant?
For qualifying micro and small enterprises, the MDR and IVDR allow the PRRC to be outside the organisation provided the person is permanently and continuously at the manufacturer’s disposal. The arrangement and responsibilities should be formally documented.
Is PRRC the same as regulatory consulting?
No. PRRC is a defined regulatory role with specific responsibilities under Article 15. Additional regulatory projects, document authoring and implementation work are separately scoped so that the formal oversight role remains clear.
Can Fabola become PRRC before our CE mark is complete?
Potentially, yes. The manufacturer’s status, product, QMS, documentation and readiness are reviewed before the appointment is accepted.
Primary regulatory sources
Last reviewed: September 2026
- Regulation (EU) 2017/745 on medical devices, Article 15 https://eur-lex.europa.eu/eli/reg/2017/745/oj
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Article 15 https://eur-lex.europa.eu/eli/reg/2017/746/oj
- Commission Recommendation 2003/361/EC on the definition of micro, small and medium-sized enterprises https://eur-lex.europa.eu/eli/reco/2003/361/oj
Related services
MDR and IVDR readiness
How far are we from being ready for CE marking under the MDR or IVDR?
Classification and conformity pathway
Is my product a medical device or IVD, what class is it, and what do I need to do to place it on the EU market?
Ready to define the work?
Tell us what the product is, where the project stands and the regulatory question you need answered.
We will confirm whether this service fits, or point you to a better starting point.
The first conversation is free and carries no commitment.