First Dermal Filler CE-marked Under Annex XVI Of The EU's Medical Device Regulation
Austrian company Croma-Pharma is the trailblazer with its newly certified dermal filler.
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The EU is putting more flesh on the bones of the requirements for Annex XVI products as two guidances are issued in quick succession.
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?
Not enough resources and the lack of readiness of the clinical investigations module are being blamed for a possible further two-year delay in the launch of the EU’s critical medtech database.