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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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.
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.
There are 10 listings in the first group of EU reference laboratory to be named. They will not formally assess IVDs for about a year and even then only evaluate products that are in a later batch to comply with the IVD Regulation.