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Two guidance documents on MDR and IVDR by EC


01st July 2019

The European Commission (EC) released two new guidance on MDR/IVDR. One of them is for the persons responsible for regulatory compliance under the Medical Device Registration (MDR) and the in vitro Diagnostic Device Regulation (IVDR) and the another one is on implant card required by MDR.

The Article 15 of MDR and IVDR states that companies must have one employee responsible for regulatory compliance with competent qualification and 4 years of professional experience in quality systems for medical devices.

Companies that have employees fewer than 50 and annual turnover not more than €10 million, can hire a third party for the responsibilities of the PRRC (person responsible for regulatory compliance) if the qualification criteria are met. The PRRC must differ from the authorized representative person.

The Article 18 of MDR is dealt in the other guidance document, which states that details like device name, serial and lot number, unique device identification (UDI), device type and manufacturer’s name, address and website should be provided on the Implant Card.

The guidance offers a symbols list that can be used on the implant card. Need of an instruction leaflet is also mentioned.


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