Module 5 Presentations

16/07/2024

New EU regulations: impacts on the clinical trials space

M-GB-00018492 Date of preparation: July 2024

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EU CLINICAL TRIALS SPACE

Benefits of the MDR and IVDR •

Improved regulatory oversight

• •

Strengthened post-market surveillance

Better traceability of devices Challenges for enabling clinical trials • High regulatory burden and complexity (no harmonized approach across Member States) • Lengthy process and variable timelines for trial authorization • Delayed access to novel healthcare products for EU patients What would help? Faster deployment of EUDAMED platform Establish a combined process for drug and device clinical trial approval (refer to next slide) Further reading on challenges and proposals: EFPIA survey

M-GB-00018492 Date of preparation: July 2024

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