Unblocking a Clinical Investigation Application Challenged by the French Competent Authority Without Impact on the Timeline

Context

An international startup was submitting a clinical investigation application in France for an innovative medical device. During the initial review, the competent authority issued a non-validation calling the product’s classification into question with a direct risk to the CE marking and the project timeline.

The challenge

Unblocking the situation quickly without jeopardising the overall project strategy. The team, unfamiliar with European requirements, needed clear and operational guidance in an urgent context.

The One Health Compliance solution

• Rapid analysis of the situation, definition of a response strategy compliant with European requirements, leveraging of existing internal data, and direct management of certain activities to meet the deadlines.

The result

• The clinical investigation application was validated by the competent authority.
• The project resumed without impact on the timeline.

✓ Application validated by the authority ✓ No impact on the timeline ✓ Overall strategy preserved

Does your situation share similarities with this case? Feel free to get in touch to discuss it.

Sandra Dejean, PharmD – Founder of One Health Compliance

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