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25% increase in Demand For Notified Bodies To Assess Annex XVI Non-Medical Products

 
• By Amanda Maxwell

The EU’s Medical Device Regulation regulates a small group of products with a mainly aesthetic purpose for the first time. How much notified body capacity will these potentially risky products demand?

Image of a breast implant
Breast Implants Are Among Products Regulated Under EU's Annex XVI

As of June 23, Notified Bodies had received a total of 80 requests from manufacturers to sign a written agreement for conformity assessment of products with no intended medical purpose that fall under Annex XVI of the MDR, a 25% increase on the total for the previous quarter.

These are products that are generally used for aesthetic purposes and are similar to medical devices in terms of functioning and risk profile.

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