EC Offers Two New Guidance Documents on MDR/IVDR
Posted 01 July 2019 | By
The European Commission (EC) on Monday released one new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro
Diagnostic Device Regulation (IVDR), and another guidance on the implant card required by MDR.
Under Article 15 of MDR and IVDR, companies are required to have at least one employee responsible for regulatory compliance with a degree in law, medicine, pharmacy, engineering or another relevant scientific discipline or four years of relevant professional experience in quality management systems relating to medical devices.
“As to the location of the PRRC [person responsible for regulatory compliance], it is important that a close linkage, of a permanent and continuous nature, is established between the PRRC and the manufacturing activities,” the EC says.
Companies with fewer than 50 employees and whose annual turnover/balance sheet total does not exceed €10 million, may subcontract the responsibilities of the PRRC to a third party as long as the qualification criteria are met and the PRRC is in the EU.
But the guidance also notes how the PRRC should not be the same person as the authorized representative.
“There is a clear desire within the Regulations for the authorised representative to be adding an additional level of scrutiny and ensure that the supervision and control of the manufacture of devices, and the relevant post-market surveillance and vigilance activities are adequately effected. If the two roles were conducted by the same person, the additional level of scrutiny would be undermined,” the guidance says. “For the same reason, the PRRC of a micro or small enterprise and the PRRC of the authorised representative of that same enterprise shall not belong to the same external organisation.”
The other guidance document deals with Article 18 of MDR, which explains what should be provided on the IC, including device name, serial and lot number, unique device identification (UDI), device type and manufacturer’s name, address and website.
“Whereas the intended purpose and most of the data elements of the IC are already defined in Article 18 of the MDR, this document contains the description of other data elements which must be completed by the healthcare institution or healthcare provider and which must be considered by the individual Member State when implementing Article 18 MDR as required,” the guidance notes.
The EC explains how, together with the IC, an instruction leaflet should be used on how to complete the IC and to explain the used symbols. But the EC also notes how there is not a symbol available for device type, so the information on the device type must be provided in the language accepted/required by the concerned member state.
The guidance also offers a list of symbols recommended for use on the IC and several examples of IC designs and leaflets.
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a "person responsible for regulatory compliance" (PRRC)
Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices