ServicesPRRC

External PRRC for medical device and IVD manufacturers

Article 15 of the EU Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation requires manufacturers to have available within their organisation at least one Person Responsible for Regulatory Compliance, or PRRC, who possesses the required expertise.

Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC are not required to have the PRRC within their organisation, but must have such a person permanently and continuously at their disposal. Fabola provides external PRRC services to eligible medical device and IVD manufacturers.

Who this is for

  • MedTech startups
  • IVD startups
  • Micro and small manufacturers that qualify for an external PRRC arrangement
  • Companies preparing for CE marking
  • Manufacturers that need an experienced regulatory function without hiring a full-time senior regulatory employee

Eligibility, qualification and suitability are assessed before Fabola accepts a PRRC appointment.

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

Likely next step

For companies that are not yet ready for PRRC appointment, the first step is usually Classification & Conformity Pathway or MDR / IVDR Readiness.

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

Other services

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?

MDR and IVDR readiness

How far are we from being ready for CE marking under the MDR or IVDR?

Clinical and performance evidence

What evidence do we actually need to support our medical device or IVD?

AI validation and evidence

How do we demonstrate that our AI-enabled medical device works reliably and safely for its intended medical use?

EU AI Act + MDR / IVDR

How does the EU AI Act interact with the MDR or IVDR for our product?

Notified Body readiness

Are we ready to submit to a Notified Body?

Regulatory intelligence

We have one defined regulatory question. Can you answer it without turning it into a six-month consulting project?

What are you building?

Whether you have an idea, a prototype, a working product, a validation study underway or a Notified Body submission approaching, we can start with the decision you need to make now.

You do not need to know which regulatory service to ask for.

Talk to Fabola

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