In recent months, we have noticed that one of the most frequently asked questions from our customers is:
“Who is the PRRC and what does he actually do?”
This is no coincidence.
With the introduction of the European MDR (EU 2017/745) and IVDR (EU 2017/746) Regulations, the role of the Person Responsible for Regulatory Compliance (PRRC) has become mandatory and this often creates confusion.
What is a PRRC?
It is the person, whether internal or external to the company, who ensures the regulatory compliance of the manufacturer or authorized representative.
In other words, he makes sure that the device placed on the market is compliant, safe, and traceable.
Commonly asked questions:
“Who is appointing the PRRC?”
- All manufacturers (including those outside the EU) and authorized representatives.
- Micro and small enterprises can outsource the role: “the PRRC can be an external partner, provided they are “permanently and continuously available”.
“What are his duties and responsibilities?”
- Verifying the device’s conformity before release.
- Guaranteeing that the technical documentation and the EU Declaration of Conformity are drawn up and updated.
- Ensuring that the post-market surveillance (PMS) system and vigilance are functioning properly.
- Overseeing any incident reports and corrective actions (FSCA).
Essentially, this is the person who is protecting the company from the risks of non-compliance, avoiding blockages, penalties, and warnings.
“What is the difference between this and a Regulatory Affairs Manager?”
The Regulatory Affairs Manager deals with operations (registrations, submissions, dossiers).
The PRRC, on the other hand, ensures that all this is done in accordance with the law; it is a role of legal responsibility and oversight.
Ok, how about in practice?
Many micro and small businesses do not have the internal resources to cover this role.
➜ In these cases, at Chemsafe, we can formally fill the role of external PRRC, ensuring continuous availability, competence, and traceability, as required by Art. 15 MDR/IVDR.
➜ Similarly, for non-EU manufacturers, we can assume the role of Authorized Representative (Agent), ensuring full compliance with European requirements.
To conclude, the PRRC is not only a regulatory requirement but also a strategic lever of reliability and safety for any manufacturer wishing to operate in a solid and transparent manner in the European market.
Does your company need:
- a qualified external PRRC, or
- An EU Authorized Representative for regulatory market access?
Contact us to evaluate the most suitable solution tailored for your case.
