Clinical Evaluation and market access under MDR

As all manufacturers will know, bringing a medical device to the EU market will shortly become a more onerous task as a result of the European Medical Device Regulation 2017/745 (MDR).The long-awaited date of application (DoA) is weeks way now (26^th May 2021) following the one year grace period granted in response to the Covid-19 pandemic.

MDR places considerably greater obligations on manufacturers (and distributors) than is the case under MDD. Specifically, they will need to demonstrate that they have fully compliant and fully integrated QMS and risk management systems in place and the requirement for clinical evaluation of new devices is extended (and more rigorous). All processes and procedures will need to be fully documented to the exacting standards set out in the legislation.

With MDR, there is a more tightly defined legal emphasis on health and safety over the full life cycle of a device, with a particular focus on post-market surveillance. The responsibility for vigilance falls squarely on the manufacturer and they will need to be able to provide evidence of indemnity where a device may cause harm.

95% of the 27,000 Med Tech companies in the EU are SMEs and the vast majority of these have less than 50 employees. Clearly, implementing MDR when bringing new devices to market represents a very significant hurdle. Meeting ever greater scrutiny and interacting with new layers of oversight will almost certainly require operating to new standards and new resources will need to be in place to support the journey to compliance. Importantly, all existing certificates issued under MDD will become void by 26 May 2024, so manufacturers will need to demonstrate to the satisfaction of the notified body before that date that their post-market surveillance plans are MDR-compliant. It may well be that a device falls into a new class under MDR and so vigilance requirements may ramp up considerably.