New Regulatory Update Briefing on MDR and IVDR
The EU is planning significant changes to MDR and IVDR. Our new Regulatory Update Briefing makes sense of the current proposals, from product delineation to integrated products.
Entourage Editorial
What it covers
The EU is preparing proposals to develop the MDR and IVDR further. The announced changes go beyond formalities and concern, among other things, the delineation between medical devices and in-vitro diagnostics and the treatment of integrated products.
Three focus areas in the briefing
- The new delineation mechanism between medical devices and IVDs
- Integrated products and the question of the "principal action"
- Accessories for Annex XVI products under the MDR
Access
Our regulatory experts track the proposals continuously and translate their practical consequences. The briefings are gathered in a dedicated hub and accessible after free registration.
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Regulations & standards considered
- EU 2017/745 (MDR)
- EU 2017/746 (IVDR)
Related projects
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Sources
- Entourage, company announcement on theentourage.de (29 Jan 2026)
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