The European Commission has launched a groundbreaking pilot program designed to expedite the approval process for medical device manufacturers seeking entry into the European market. This initiative introduces a coordinated assessment procedure that allows a single application to be reviewed by multiple EU member states, potentially reducing the time and effort required for market access.
Innovative Assessment Mechanism Unveiled
Integrated within the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), the coordinated assessment procedure streamlines the submission process. A designated coordinating member state will oversee the application, sharing a draft assessment report with other participating states. If no objections arise, the coordinating state’s conclusion will be accepted across all involved member states, simplifying the regulatory landscape for manufacturers.
Pilot Program Specifications and Eligibility
On February 6, 2025, the European Commission announced a pilot “call for applications” targeting coordinated assessments for Clinical Investigations and Performance Studies (CI/PS). The program aims to refine the assessment procedure ahead of the full implementation of the EUDAMED CI/PS module. Eligible applications must pertain to Class III or invasive Class IIa/IIb medical devices and involve sites in at least two participating EU member states, including Norway.
Key Inferences:
- The pilot aims to reduce administrative burdens for manufacturers by enabling multi-country submissions.
- Enhanced collaboration between member states is expected to harmonize regulatory assessments.
- Successful implementation could set a precedent for future regulatory processes within the EU.
Manufacturers and sponsors planning to conduct clinical investigations across multiple EU countries are encouraged to express their interest by June 30, 2025. Applications will be submitted through the CIRCA-BC system, with the European Commission selecting participants to participate in the pilot. A subsequent call for in vitro diagnostic submissions will be announced at a later date.
This pilot program represents a significant advancement in the European regulatory framework for medical devices. By enabling a unified application process, the European Commission seeks to foster innovation and ensure timely access to essential medical technologies. Manufacturers participating in the pilot will play a crucial role in shaping a more efficient and cohesive regulatory environment, ultimately benefiting both the industry and healthcare sectors across Europe.
Stakeholders are advised to stay informed about further developments related to the coordinated assessment procedure and the operational status of the EUDAMED CI/PS module. Engaging early with this pilot offers manufacturers a strategic advantage in navigating the complex EU regulatory landscape, ensuring compliance and accelerating the introduction of innovative medical devices to the market.
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