The MDCG (Medical Devices Coordination Group) plays a crucial role in the current transition phase from the Medical Devices and In Vitro Medical Devices Directives to the Medical Devices and In-Vitro Medical Devices Regulations 2017/745 and 2017/746 as it provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of the Regulations.
Its guidance documents are crucial and helpful to understand some novelties that have been brought about by MDR and IVDR.
On July 1st 2019, a MDCG guidance has been published to better clarify the role of PRRC (Person Responsible for Regulatory Compliance). The main clarifications focused on qualification of the PRRC, that should always be a Manufacturer’s employee (if the Manufacturer employs more than 50 persons and if its annual turnover/annual balance sheet total exceeds 10 million Euros, as specified in this Commission Recommendation). Any qualification acquired outside the EU should be recognized as equivalent to a EU qualification by a Member State. In case the same Organization has more than one legal manufacturer, each legal manufacturer will have to have its own PRRC. Furthermore, it is requested for the PRRC to have a close linkage with the manufacturing activities, of a permanent and continuous nature. Should the manufacturer be located outside the EU, the PRRC should be as well. On the contrary, should the manufacturer be located inside the EU, the PRRC should be as well.
Differently from normal-sized manufacturers, micro and small manufacturers may decide to subcontract the responsibility of the PRRC to an external entity, provided that that such entity is permanently and continuously at the manufacturer’s disposal and that the contract clearly indicated the PRRC’s qualifications.
Authorised representatives (AR) are obliged to have a PRRC as well. Some requirements are listed for AR’s PRRC as well both in terms of education and experience.
In particular,
- 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’’ are required.
In AR’s case as well, the PRRC’s role can be outsourced.
On the roles and responsibilities of the Manufacturer’s PRRC: the MDGC Guidance does not provide information on the tasks to be performed by the PRRC, but refers to art. 15(3) of the MDR.
On the roles and responsibilities on the AR’s PRRC: the guidance refers to art.11(3) of MDR to clarify that the PRRC must supervise over the AR’s tasks to make sure that the mandate is exactly executed.
The Guidance clarifies that the PRRC’s roles for the AR and for the Manufacturer cannot overlap for the sake of keeping an additional level of scrutiny entrusted to the AR as envisaged by the Regulations. The same ratio applies for medium sized and micro or small sized manufacturers.
If you wish to be updated about the MDR, know more how the MDR may impact your business and how to get ready for the new Regulation, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU legislation, will gladly answer any question you may have and assist you with your products’ compliance.
July 15, 2019
Francesca Zuccarello Cimino
Publications Department
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