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’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.
Following the timelines laid out in the European Commission’s new implementing regulation for Annex XVI non-clinical devices is not for the faint-hearted. It involves multiple cross-referencing between several commission regulations. Medtech Insight clarifies the situation.