Module 5 Presentations

16/07/2024

Health Authority(HA) requirements for device clinical trial authorization (initial): based on IVDR and MDR This is a

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M-GB-00018492 Date of preparation: July 2024

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Example timelines for a CTR-IVDR HA approval of a Roche study^

STAGE OF APPLICATION

CTR

IVDR (Country 1)

IVDR (Country 2)

Submission to EC* and HA

1 Aug 2023

1 Aug 2023

1 Aug 2023

Validation of submission

14 Aug 2023

11 Aug 2023

11 Aug 2023

Approval

Part I: 20 Nov 2023 Part II:26 Oct 2023 (country 1) : 23 Oct 2023 (country 2)

HA approval: 17 Nov 2023 EC approval: 26 Oct 2023

HA approval: 16 Nov 2023 EC approval: 24 Oct 2023

^Downside: it is not known if similar approach for a study with more EU countries would have had synchronized timelines

*Ethics committee (EC): EC approval is a basic ISO requirement for all studies involving patients/subjects even when a study does not require a HA notification/submission.

M-GB-00018492 Date of preparation: July 2024

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