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

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

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