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New Regulatory Update Briefing on MDR and IVDR

The European Commission has put forward significant changes to MDR and IVDR. Our new Regulatory Update Briefing makes sense of the current proposals, from product delineation to integrated products.

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Entourage Editorial Team

What it covers

On December 16, 2025, the European Commission presented its proposal to develop the MDR and IVDR further (COM(2025) 1023 final, procedure 2025/0404(COD)). The proposed 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 the Regulatory Update Hub and accessible after free registration. The Commission's reform proposal for the MDR and IVDR is analyzed in depth in MDR/IVDR under reconstruction.

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Regulations & standards considered

  • EU 2017/745 (MDR)
  • EU 2017/746 (IVDR)

Related expertise

MDR Conformity →

Support through classification, technical documentation and conformity assessment.

IVD Consulting & IVDR Readiness →

Interpreting and implementing IVDR requirements along the product classes.

Related projects

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Case Study

Design Transfer of Combination Products from Development to Production

A medical device company with combination products needed to make the design transfer from development to production more efficient while overcoming regulatory hurdles under the EU MDR and the FDA.

Case Study

Global Market Access After the IVDR Transition: 100 Percent On-Time TGA Submissions

Following the transition to the IVDR, a diagnostics manufacturer had to meet pressing compliance deadlines set by the Australian Therapeutic Goods Administration, with limited internal capacity and diverging requirements across multiple international markets.

Sources
  • Entourage, company announcement on theentourage.de (Jan 29, 2026)
  • European Commission, proposal COM(2025) 1023 final of 16 Dec 2025, procedure 2025/0404(COD)

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MDR/IVDR changes

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