Last Friday, Stella Kyriakides, Health Commissioner for the European Union, recommended pushing backward the enforcement date for a new regulation governing medical devices from 2024 to 2028. This significant revision is required to avoid scarcities of life-saving supplies.

The statement comes in response to protests from trade organisations and doctor associations, who cautioned that a large quantity of essential equipment will inevitably vanish from the EU market if adjustments were not made to the Medical Devices Regulation statute, which went into force last year.

“EU Health Commissioner recommended pushing backward the enforcement date for a new regulation governing medical devices from 2024 to 2028“

Between 20,000 and 200,000 devices marketed in the trade bloc are subject to higher safety standards under the new regulation, which also mandates that all equipment must be recertified.

Kyriakides suggested increasing the amount of time manufacturers have to verify devices in the new system- now extending the cut off to 2027 for high risk and 2028 for medium and low risk. She also advised doing rid of the May 2025 "sell-off" deadline in order to prevent the waste of what is currently available on the market.

Kyriakides recognised that the EU medical devices industry's changeover to a different governing structure had taken longer than expected.

Along with the understandable implications of the Covid 19 pandemic, raw material scarcities brought on by the Russia- Ukraine conflict, and additional admin personnel shortages have all “put a strain on market readiness".

There is an enormous risk that a high number of medical devices that are now available in the EU may not have their documentation up to date by the existing cut off unless the certification process speeds up significantly.

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