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European Commission Publishes Draft Rules In Bid To Reclassify Non-Medical Active Products

 
• By Amanda Maxwell

The European Commission has launched an initiative to ensure products without a medical purpose that fall under the Medical Device Regulation are appropriately classified by risk, and subject to the same pre- and post-market requirements as comparable medical devices.

(MicroStockHub/Getty Images/iStockphoto)

The European Commission has published a draft implementing regulation on the reclassification of certain active products that fall under the scope of the Medical Device Regulation (MDR), but which do not have an intended medical purpose.

The intention is to adopt the new regulation during the third quarter of 2022.

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