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Commission Text Clarifying Timelines For Annex XVI Devices May Leave Companies Dazed

 
• By Amanda Maxwell

The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.

Cosmetics anti aging
• Source: Shutterstock

The European Commission has published a seven-page Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the Medical Device Regulation and which generally have an aesthetic or well-being function, such as dermal fillers and colored contact lenses.

The Q&A is intended to explain the content of Commission Implementing Regulation EU 2023/1194, adopted to align the transitional...

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