EU MDR 2017/745 & IVDR 2017/746 Pilot Coordinated Assessment 2025 Update

The EU MDR 2017/745 and IVDR 2017/746 pilot coordinated assessment for clinical investigations and performance studies began on 10 November 2025, enabling a single application for multi-country submissions. This initiative supports more harmonised review across Member States and prepares authorities for the future EU coordinated assessment system. The pilot is a major step for sponsors planning EU medical device or IVD clinical studies.

What the 2025 Pilot Coordinated Assessment Covers

On 10 November 2025, the European Commission launched a voluntary pilot coordinated assessment under MDR Article 78 and IVDR Article 74. The project allows sponsors to submit one application for a clinical investigation or performance study involving multiple EU/EEA Member States.

Eligible studies include:

• MDR: Class III devices and invasive Class IIa/IIb devices

• IVDR: Performance studies under Article 58(1)(b), 58(1)(c) or 58(2), including companion diagnostics

• Multinational studies involving two or more participating Member States

This coordinated approach reduces duplication, brings greater transparency, and supports a unified EU evaluation process.

How the Pilot Improves EU CI/PS Submissions

The 2025 pilot offers several operational advantages for sponsors:

• A single EU-facing submission process: Sponsors communicate primarily with one coordinating Member State, reducing the complexity of parallel national procedures.

• Harmonised regulatory expectations: Member States collaborate on shared assessments, helping align interpretations of MDR/IVDR requirements.

• Faster, more predictable timelines: By eliminating repetitive requests across countries, sponsors may benefit from clearer timelines and fewer administrative hurdles.

• Support for future mandatory implementation: The pilot helps authorities build the systems needed once coordinated assessment becomes mandatory under MDR Article 78(14) and IVDR Article 74(14), as amended by Regulation (EU) 2024/1860.

Why Early Participation Matters for Sponsors

Participation in the pilot gives manufacturers and developers several strategic advantages:

• Familiarity with the upcoming mandatory EU-wide system

• Insights into coordinated procedures and document expectations

• Opportunities to refine internal processes for future submissions

• Possible acceleration of multinational clinical timelines

Sponsors interested in joining must submit an expression of interest to the Commission (SANTE-CA-CIPS@ec.europa.eu).

Key Actions for Sponsors Preparing for Coordinated Assessment

To make the most of the pilot and prepare for full implementation, sponsors should:

1. Review the MDR and IVDR requirements for their device category.

2. Align documentation with the MDCG templates and guidance used for EU-wide assessment.

3. Develop a harmonised multinational study plan, ensuring consistency across participating countries.

4. Prepare for remaining national elements such as ethics approvals, local language requirements, and site-level compliance.

Internal links

• Learn more about EU MDR Consulting

• Learn more about EU IVDR Consulting

External links

• European Commission — Pilot Coordinated Assessment for CI/PS

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