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MDR delayed, but was the industry ready?

The European Parliament and Council has voted to delay the enforcement of the new Medical Devices Regulation (MDR). Set to replace the current Medical Device Directive (MDD), the MDR will now come into effect in May 2021, a year later than planned.

Their decision was made in response to the COVID-19 crisis. In light of the pressure on national health authorities and manufacturers of medical devices, it was hoped that this delay will allow them to focus entirely on fighting COVID-19 and prevent shortages or delays in getting key medical devices on the market.

But would the industry have been ready to meet the MDR this May? Even before the pandemic hit, there was widespread unease about whether companies or the industry as a collective would be ready for the impending alterations.

Illustration of the first 3 steps of the medical device regulation process

It’s true that the medical device industry has had since 2017 to make changes to products and processes in anticipation of the MDR. However, the lack of clarity and guidance from the European Medicines Agency (EMA) has left many organisations struggling to meet the new standards in time. A survey by the Regulatory Affairs Professionals Society (RAPS) indicated that only a quarter of medical device companies would be in a position to be fully compliant with MDR standards by May 2020.

Another major issue during this transition period is the lack of Notified Bodies currently certified under the MDR. Notified Bodies are the independent companies able to CE mark any new product; an essential step in releasing any new device onto the market. It is therefore crucial for these organisations to secure certification under the new standards.

Illustration of steps 4 to 7 of the medical device regulation process

Though ever changing, there are currently only 14 certified under the MDR, compared to 53 Notified Bodies under the MDD. The delay in implementing the MDR will not only give Notified Bodies more time to gain the new certification, but it will also allow companies the opportunity to get their devices CE marked.

2020 has been a challenging year for many industries due to COVID-19. Medical device industry group MedTec Europe has welcomed the delay of the MDR, stating “The amendment will allow the medical device industry to maintain maximum focus on helping healthcare systems to combat COVID-19, and on addressing the pandemic’s impact on the whole healthcare ecosystem.”.

Illustration of steps 8 to 10 of the medical device regualtion process

The deferral of the MDR will not only help with the COVID-19 efforts, but it will also give the industry time to further adjust and prepare for the new regulations. The Mutual Recognition Agreement with Switzerland regarding the MDD and AIMDD will remain in place for one year longer.

Postponing the MDR until May 2021 should allow sufficient time for preparation, and the industry has breathed a sigh of relief.

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