The European Commission has launched the CIPS pilot program to streamline and accelerate the clinical investigation assessment process for medical devices in the EU. The program aims to introduce a harmonized approach to clinical trial approvals across multiple countries simultaneously.
Until now, clinical trial assessments in EU countries were fragmented, often leading to delays in registering new medical technologies. The CIPS (Coordinated Assessment for Clinical Investigations and Performance Studies) program seeks to harmonize the clinical assessment process and establish a more unified regulatory system.
CIPS Program Objectives
- Standardizing Clinical Investigation Approval Procedures – Manufacturers conducting clinical trials in multiple EU countries currently face the challenge of submitting separate applications in each country, leading to inconsistent decisions and significant delays. CIPS introduces a unified assessment system enabling a single decision applicable across participating countries.
- Accelerating the Registration Process – The coordinated assessment process eliminates redundant application processing steps, reducing the approval time for clinical investigations by several months.
- Enhancing Efficiency in Clinical Data Assessment – Harmonization of methodologies and approval criteria allows regulatory bodies to better utilize resources and compare clinical investigation results across different countries.
- Improving Access to Innovative Therapies – Shortening the clinical trial approval timeline ensures that patients in Europe gain faster access to new, safe, and effective medical devices.
How the CIPS Program Works?
- Regulatory bodies from different EU countries analyze documentation within a single coordinated process.
- Clinical trials will be assessed using a single set of criteria instead of varying national standards.
- Eliminating redundant national procedures reduces approval timelines.
Conclusion
The CIPS pilot program has the potential to significantly improve the clinical investigation assessment system in the EU. It will allow manufacturers and researchers to conduct studies more efficiently, ultimately enabling patients to access innovative medical technologies more quickly.
