PRRC
PRRC
The EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746 each require, in accordance with Article 15, that all medical device and IVD manufacturers, as well as authorised representatives, appoint one or more Person(s) Responsible for Regulatory Compliance (PRRC).
While the role of the PRRC shares similarities with the former Safety Officer under §30 of the old Medical Devices Act (MPG), it is not identical. The responsibilities and significance of the PRRC go far beyond those of the former role.
Both the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746) set out strict qualification requirements for the PRRC. These include either a university degree combined with one year of professional experience in regulatory affairs or quality management systems related to medical devices, or four years of professional experience in these areas. For some manufacturers, meeting these requirements can pose a significant challenge.
If your company qualifies as a micro or small enterprise — with annual turnover below 10 million euros and fewer than 50 employees — then you’ve come to the right place. MDSS Consulting GmbH is pleased to offer the services of one of our highly qualified and experienced professionals to act as your external PRRC.
You decide whether we should take over the full scope of responsibilities or support you with selected regulatory tasks only (modular engagement).
Together, we’ll find the right solution that fits your needs.
The tasks of a PRRC
Device Conformity Verification
The conformity of devices is verified in an appropriate manner in accordance with the requirements of the quality management system under which the devices are manufactured before they are released.
Preparation and updating of technical documentation and EU declaration of conformity
Technical documentation and the EU declaration of conformity are prepared and kept up to date.
Notification to authorities
Reporting obligations are fulfilled in accordance with Articles 87 to 91 (MDR) and Articles 82 to 86 (IVDR).
Declaration of clinical trials/performance studies
For investigational devices, the declaration is submitted in accordance with Annex XV, Chapter II, Section 4.1 (MDR). For devices for performance studies intended to be used in interventional clinical performance studies or other performance studies involving risks for the trial subjects, the declaration referred to in Annex XIV, Section 4.1 (IVDR) is submitted.
