On July 1st 2019, a MDCG guidance has been published to better clarify the role of PRRC.
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).
PRRC should possess professional experience in regulatory affairs or in quality management systems relating to medical devices. 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.
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.
SMS companies 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.
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, 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 of any size cannot overlap for the sake of keeping an additional level of scrutiny entrusted to the AR as envisaged by the Regulations.
We will keep you informed about any further update on our News section .
More information on the PRRC can be found on MDlaw Library of Documents.