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

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.

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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 provisions and dates set out in the Common Specifications (technical requirements) for Annex XVI products with those set out earlier this year with the publication of the MDR amending regulation

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