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The European Union has proposed delaying the implementation date for the upcoming In Vitro Diagnostics medical device regulation due to the backlog caused by the COVID-19 pandemic. So far, only six entities have currently been certified.

The regulation was initially scheduled to come into effect from May 2022, but the EU now plans to proceed with a progressive rollout. The proposal for the delay is due to be put forward to the European Parliament and Council.

Commissioner for Health and Food Safety Stella Kyriakides said: “The COVID-19 pandemic has shown how essential it is to have accurate diagnostics and a robust regulatory framework for in vitro medical devices. Shortages at this point in time are unthinkable.”

“The pandemic has imposed unprecedented challenges also for our medical devices industry. With more time to prepare for the application of the EU new rules, we will ensure there is a continuous supply of essential in vitro diagnostic medical devices on the market, while not compromising on safety.”

“I call on all manufacturers to prepare for certification under the new Regulation as soon as possible and not wait until the end of the transition period.”

Despite years of industry pressure, regulators had refused to entertain the possibility of delaying the rules. However, this changed with the onset of the COVID-19 pandemic, with the initially scheduled implementation date of May 2021 being delayed by a year.

As far as the new rules are concerned, CE-marked devices that don’t require further coordination from notified bodies must still comply with the regulation by May 2022. For other device, transition periods would depend upon their riskiness, with the highest category having until 2025/26 and lower risk devices having until May 2027.

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