What does a PRRC do?
First things first. The PRRC stands for Person Responsible for Regulatory Compliance and is a “new animal in the zoo” of the MDR and IVDR. This new position has been pointed out in article 15 of both the Medical Device Regulation (MDR) 2017/745 and the In-vitro Medical Device Regulation (IVDR) 2017/746 demanding a single person to take this role within a medical device company.
The role of the PRRC is to take care of
The PRRC, as the name demands, takes care of regulatory affairs and the compliance. Within the regulatory affairs, most probably starting during development, the PRRC is responsible for:
Within the regulatory affairs, most probably starting during development, the PRRC is responsible for:
On the compliance side, the PRRC is responsible for:
However, the PRRC is not asked to actually do all these tasks by him/herself, instead is responsible for and might delegate the one or other task. In fact, there is a guidance on the PRRC published by the EU.
The specification of a PRRC
The regulations are demanding a certain “specification” or competencies a PRRC must fulfill, which basically lies with the education and experience of such a person.
A PRRC must fulfill at a minimum and prove by evidence that either one is given:
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Is the PRRC the same as a Qualified Person or my Quality Manager?
There are a lot of synonyms around for the PRRC which makes a distinction harder than expected. The PRRC is sometimes referred to as Qualified Person, in analogy to the Qualified Person demanded for medicinal products. But has a PRRC to fulfil the same tasks as a Qualified Person known from pharmaceutical manufacturers?
In short: No!
What happens if I don’t employ a PRRC?
Article 15 is very clear that there is no carence time for employing a PRRC under MDR. In fact, you need one from the beginning! In addition, the PRRC must be registered in the EUDAMED (since EUDAMED is not operational yet, this is on hold) or another, local (on country level) register, e.g. in Germany the DIMDI.
On a member state level, i.e. country level, fines can be defined in the national legislation which not seldom reach Euro 30’000.00 per case.
So, is the PRRC solely liable?
Before coming to the liability question, both the MDR and the IVDR proclaim and demand that the PRRC must not be disadvantaged due to their duties.
Liability is usually limited to the company in cases of minor negligence and the PRRC is save behind the company doors. However, in cases of gross negligence, the company can take regress and make the PRRC liable.
Consequences for the PRRC might arise only in the event of gross negligence and intent. In such cases, the PRRC might be charged with criminal law consequences
Who needs a PRRC?
A PRRC is needed for every manufacturer of medical devices or in-vitro diagnostics and in some cases for EC Authorized Representatives and Distributors as well. The PRRC must be an employee of the company unless the company is a micro- or small company, as defined in the guidance by the EU.
Depending on the company and its products, the PRRC must be employed internally or can be externally staffed.
|Enterprise||Small Company||Micro Company||Custom-Made manufacturer||Distributor||EC REP|
Revenue [Mio €]
Manufacturers, distributors and EC Reps are advised to staff their company with a PRRC either as an internal employee or an external contributor.
Talk to us in case of questions regarding this content or if you are in need of an external PRRC.