Outsourced PRRC: your Person Responsible for Regulatory Compliance.
MDR Article 15 requires you to appoint a PRRC. If you are a micro or small enterprise, that person does not have to be on your payroll. We take on the role for you, on a monthly subscription, with no long-term commitment.
Initial scoping is free, with no commitment. Monthly subscription, no long-term commitment.
What you get
- Periodic reviews
- Documentary compliance
- Vigilance
Good to know
- Micro and small enterprises (MDR Art. 15(2))
- Subscription with no long-term commitment
Ideal if: you are a micro or small enterprise and nobody in-house meets the conditions to hold the PRRC function.
What MDR Article 15 really requires
Every manufacturer under the MDR must have at least one person responsible for regulatory compliance, the PRRC (known in French as the PCVRR). There are no exceptions to this obligation.
What the regulation does allow, and many people are unaware of it, is that micro and small enterprises are not required to have this person within their organisation. Article 15(2) allows them to rely permanently on an external PRRC, provided they can demonstrate that this person is permanently and continuously at their disposal.
The required qualifications are specific. The PRRC must have either a diploma in law, medicine, pharmacy, engineering or another relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, or four years of experience in those fields.
It is up to the manufacturer to gather the evidence that the appointed person meets these conditions. A poorly documented appointment is a finding at audit.
Why it is a headache for a small company
The profile is rare and expensive
A regulatory professional qualified within the meaning of Article 15 is hard to recruit, and rarely available part time. For a company with fewer than ten people, the position is out of proportion.
Appointing someone internally by default is risky
Many small companies appoint the CEO or the quality manager without checking that the profile meets the criteria. The gap surfaces at the first Notified Body audit, at the worst possible moment.
The role never stops
The PRRC must ensure compliance before each batch release, and oversee the technical documentation, the declaration of conformity, and post-market surveillance and vigilance obligations. It is not a one-off assignment, it is continuous oversight.
An external PRRC who sees your documents continuously
A traditional outsourced PRRC discovers your documentation at review time. Ours works from a document base that is analysed continuously.
Every engagement includes setting up My Audit Corner on your documents, handled by our team. The platform tracks the status of your quality management system and technical files continuously: when a document changes, the gap is flagged immediately, without waiting for the next review.
Our experts can then spend their time on what really matters, namely regulatory judgement and decisions, rather than rereading hundreds of pages to find out what has changed.
You keep shared access to the platform for the full duration of the engagement.
Frequently asked questions
Yes, but with conditions. MDR Article 15(2) reserves this option for micro and small enterprises as defined in European Commission Recommendation 2003/361/EC. These companies are not required to have the PRRC within their organisation, provided that person is permanently and continuously at their disposal. Above these thresholds, the PRRC must belong to the organisation.
None. PCVRR is the French term (“personne chargée de veiller au respect de la réglementation”) and PRRC the English acronym for “person responsible for regulatory compliance”. Both refer to the same role, defined in MDR Article 15. French professionals commonly use both.
We prepare the evidence relating to the PRRC role (appointment, proof of qualifications, review minutes) and make ourselves available for the audit. Demonstrating that the appointed person meets the Article 15 criteria is part of the deliverable from day one.
No. The PRRC ensures regulatory compliance on points precisely defined by Article 15. They do not run your quality management system day to day. Many of our clients combine the outsourced PRRC with another service, such as a QMS build or custom regulatory watch.
It is confirmed after the free scoping session, based on the number of products, their class and your markets. Like all our services, it is a fixed monthly fee, never billed by the hour.
Need a PRRC without hiring one?
Tell us about your situation. We will quickly tell you whether Article 15(2) applies to you and how we can take over the role.