New EU Coordinated Assessment Pathway for Clinical Investigations: Key Insights for Device Manufacturers
Introduction
The European Commission has initiated the Pilot Coordinated Assessment for Clinical Investigations and Performance Studies (CI/PS), a major measure in the direction of making the process of getting approval for medical devices, as well as in vitro diagnostics, throughout the EU faster and smoother. This initiative aims to streamline multi-country submissions by enabling one coordinated assessment for clinical investigations under the Medical Devices Regulation (MDR) and performance studies under the In Vitro Diagnostic Regulation (IVDR).
What the Pilot Program Offers
In the current situation under MDR and IVDR regulations, the sponsors are conducting their studies in several Member States; not only have to deal with different timelines for reviews, but they also receive feedback that is not even the same. The reform in the pilot program is going to change that by granting:
A Centralized, Coordinated Review Process
Sponsors will now be able to submit a single application dossier for multi-national studies. A designated Reporting Member State (RMS) will lead the scientific and ethical assessment, reducing redundancy and significantly improving predictability.
Increased Transparency and Efficiency
The coordinated procedure is meant to set the stage for taking the approval process down to the shortest time possible, besides making access to the innovative technologies faster, not only for patients but also for manufacturers who come up with those new technologies, hence it will cut the approval times down.
Alignment With MDR and IVDR Requirements
The pilot consolidates the area of interfacing with MDR/IVDR requirements by including such things as clinical evidence planning, safety monitoring, and data integrity.
Who Should Participate?
The Pilot Coordinated Assessment welcomes participation from manufacturers and sponsors planning clinical investigations or performance studies across multiple EU Member States. Early engagement may be particularly beneficial to:
⦿ High-risk medical device developers
⦿ IVD manufacturers preparing for IVDR-driven evidence requirements
⦿ Companies preparing for CE Marking and EU Notified Body reviews
Elexes helps medical device and IVD manufacturers evaluate study requirements, prepare compliant CI/PS dossiers, and coordinate with EU authorities.
Our team guarantees compliance with MDR/IVDR criteria, in cooperation with the generation of clinical evidence, and also provides help in making documentation for multi-country submissions harmonized. The organizations contemplating conducting clinical investigations or performing studies in the EU will be able to make the most of a pilot project for obtaining approvals that are quicker and more predictable.
Contact Elexes to ensure your submission is compliant, complete, and strategically positioned for success.
