Billev Pharma East experts can act as your outsourced PRRC, helping your Company comply with EU regulations for medical devices and IVDs. Our experts are there to be counted on and bring their expertise to your Company.
The medical device and in vitro diagnostic (IVD) industry has undergone significant regulatory changes with the introduction of the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746 in the European Union. A crucial element in this regulatory framework is the Person Responsible for Regulatory Compliance (PRRC).
The introduction of the PRRC role under Article 15 of the MDR and IVDR signifies a strategic move towards enhancing the oversight and enforcement of regulatory compliance within the medical device sector. Manufacturers and, where applicable, their EU authorised representatives are required to appoint at least one PRRC.
It is noteworthy that a PRRC cannot serve both a manufacturer outside the EU and the manufacturer’s EU authorised representative.
The eligibility criteria for a PRRC are outlined in Article 15(1) of both the MDR and IVDR. The PRRC must possess either a formal qualification in a relevant scientific or legal field, accompanied by experience in regulatory affairs or quality management systems related to medical devices, or four years of professional experience in these areas.
The responsibilities of a PRRC are comprehensive, covering various aspects of regulatory compliance from ensuring the conformity of devices to maintaining up-to-date technical documentation and fulfilling post-market surveillance obligations. For manufacturers, the PRRC plays a critical role in the quality management system, a position that is integral to the organization’s operational integrity and subject to audit scrutiny.
The MDR and IVDR allow for the distribution of responsibilities among multiple PRRCs, provided that qualifications are met and responsibilities are clearly documented.
Due to the operational challenges of small and micro enterprises, the EU MDR and IVDR offer provisions for outsourcing the PRRC function to external experts. This flexibility, however, comes with requirements to ensure that the outsourced PRRC is permanently and continuously available.
