Coordinated pilot evaluation for clinical investigations and performance studies

The European Commission , in collaboration with Member States , has launched a pilot project for coordinated assessment of clinical investigations and performance studies of medical devices. This pilot allows sponsors to submit a single application for coordinated assessments, promoting more harmonized interaction with Member States responsible for approving clinical investigations.

The aim is to implement a harmonised and predictable process across the European Union, reducing the administrative burden and ensuring greater transparency and consistency in coordinated assessment.

The main benefits include:

• Unified engagement with the countries involved, streamlining communication and reducing delays.

• Greater transparency and harmonization in evaluation processes.

• Consistency in assessments by reducing discrepancies in national interpretations.

• Efficiency in document management and substantial modifications during the evaluation process.

• Faster decisions at national level thanks to coordinated procedures.

This pilot is an important step in the preparation for the mandatory operation of the coordinated assessment system, as required by Article 78 of Regulation (EU) 2017/745 (MDR) and Article 74 of Regulation (EU) 2017/746 (IVDR) .

For more information, visit the official website of the European Commission .

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