EU MDR requires onsite Person Responsible for Regulatory Compliance
Daniele Lioi, Senior Consultant and Team Leader, Eurofins Medical Device Consulting, DanieleLioi@eurofins.com
The Medical Devices Regulation (MDR) (EU 2017/745) has recently established significant changes to European legislation in relation to medical devices. Article 15 of MDR now requires that manufacturers and Authorised Representatives (ARs) must have at least one Person Responsible for Regulatory Compliance (PRRC) nominated within their organisation.
Who is the PRRC? The PRRC is a qualified professional who is a university or other form of formal education graduate in law, medicine, pharmacy, engineering or another relevant scientific discipline, and has at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices. Alternatively, a person with at least four years professional experience in regulatory affairs or with medical device quality management systems is eligible to become a PRRC. The PRRC should be an employee of the manufacturer (or the AR), unless the company has fewer than 50 employees and an annual turnover less than EUR 10 million. In this case, the organisation can outsource the PRRC role to an expert.
What are the responsibilities of a PRRC? The PRRC has to supervise and control the manufacturing of medical devices and carry out post-market surveillance and vigilance activities. The PRRC has to make sure that the conformity of the devices is appropriately checked before a device is released; that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; that the post-market surveillance obligations are compiled; that the reporting obligations referred to Vigilance in Articles 87 to 91 are fulfilled; and that, in the case of investigational devices, the required statement (ref. Section 4.1 of Chapter II of Annex XV) is issued.
Eurofins support for manufacturers: Eurofins’ experts provide support to Medical Device Manufacturers to meet PRRC requirements, including role outsourcing. Visit: www.Eurofins.com/Medical-Device for all assistance needed.
