Call for expression of interest in coordinated assessment of clinical investigations/performance studies

Regulatory Affairs Medical Devices In Vitro Diagnostics

Wednesday, 05 March 2025

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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

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On February 6th, 2025, the EU Member States and the European Commission announced the launch of a pilot coordinated assessment of clinical investigations under Regulation (EU) 2017/745 (MDR) and performance studies under Regulation (EU) 2017/746 (IVDR) across multiple Member States.

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Call for expression of interest in coordinated assessment of clinical investigations/performance studies

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This pilot will allow sponsors to submit a single application for pilot coordinated assessments, assuring more harmonised interaction with the Member States approving the clinical investigation or performance studies. Additionally, participants will help the national competent authorities with building an EU system for coordinated assessment once its mandatory operation starts.

Sponsors of medical device clinical investigations who are interested in participating in the EU pilot coordinated assessment should express their interest via email using a template provided by the European Commission. The call for IVD performance studies will be announced at a later date.

Pilot coordinated assessment for clinical investigations / performance studies

What is the pilot project about?

MDR Article 78(14) and IVDR Article 74(14) require implementation of coordinated assessment procedures across Member States for clinical investigations and performance studies. Member State participation in these assessments is voluntary until 27 May 2027 (MDR) or 27 May 2029 (IVDR). The following Member States have now expressed interest in participating in a pilot project for coordinated assessments: Austria, Belgium, Czech Republic, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovenia, Spain, Sweden and Norway. The selected clinical investigations or performance studies must be multinational, involving at least two of the above Member States, and require authorisation under MDR Article 62(1) or IVDR Article 58(1-2). More information is provided in a FAQ document that discusses organisational, practical and financial aspects for sponsors considering stepping into the pilot. The expressions of interest will be reviewed based on eligibility criteria and potential impact on public health.

By participating in the pilot for coordinated assessment, sponsors can benefit, amongst others, from enhanced transparency and increased harmonisation, simplified requests for information, more efficient document management, and a faster overall process. Pilot program results will be shared with participating Member States, and non-participating Member States may access the findings if the sponsors grant permission.

At this moment, the call is open for sponsors of medical device clinical investigations; IVD performance studies will follow at a later stage. Sponsors who are interested can fill out the form provided by the European Commission and email it to SANTE-CA-CIPS@ec.europa.eu by June 30th, 2025.

What does it mean to you?

This call for expression of interest is important for all sponsors of upcoming multinational clinical investigations and performance studies that require study authorization. Whether these investigations/studies are stand-alone or linked to a clinical trial of a medicinal product, this pilot is an important step in reducing the administrative burden for sponsors and improving transparency and predictability of the authorization process.

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