PRRC: the new profession is getting organised
Despite the fact that the MDR represents a tall order for many medical device manufacturers, the changes that have been introduced (to its predecessor the MDD), are not radical transformations, as most of the new requirements are predominantly extensions to already existing ones. But the requirement introduced in article 15, is one of the few true novelties of the EU MDR (and IVDR). The objective of bringing more regulatory control have engendered, via article 15, a new profession: the “Person responsible for regulatory compliance” (PRRC) (1).
According to this article, manufacturers are required to include in their team (hire) at least one Person Responsible for Regulatory Compliance. Micro and small enterprises (2) as well as Authorised representatives do not have the obligation to hire a PRRC, however, they must have such a person at their disposal permanently and continuously. In some cases, described in the following article 16, the manufacturers obligations related to PRRC is also applicable to importers and distributors.
The EU has published in July 2019, a guidance document with the purpose of clarifying the new requirements in regard to the PRRC as well as providing complementary information.
The important responsibilities lying upon the Person Responsible for Regulatory Compliance, has led, to the creation of a unique European Association. The non-profit European Association called Team-PRRC, has officially launched its activities on April 2, 2020, with the goal of accompanying PRRCs in their newly established tasks and responsibilities. Team-PRRC presents its mission as follows (3):
"- Exchange experience on issues faced by PRRC in their daily activities; propose and exchange solutions;
- Establish, maintain and develop a high level of professionalism of PRRC;
- Exchange information with health authorities in charge of national, European and international regulation;
- Act as a moderator and support PRRC in conflicts or disputes raised during their day-to-day activities; - Aim for enhancement of Public Health; - Pursue for mutual assistance between TEAM-PRRC members.”
Baguette translations will follow with interest how this newly created position evolves along with real life practice.
Stay tuned!
(1) Article 15 of REGULATION (EU) 2017/745: “Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.”
(2) Within the meaning of Commission Recommendation 2003/361/EC, 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
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