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EU In Vitro Diagnostics Regulation

On May 26, 2022, the EU In Vitro Diagnostics Regulation (IVDR) has come into effect with specific rules for the submission, review and conduct of performance studies using in vitro diagnostics.

EU Clinical Trial Regulation (CTR)

On January 31, 2022, the EU Clinical Trial Regulation (CTR) 536/2014 has come into effect with new rules for research with medicinal products in the European Union. From January 31, 2023, all initial applications of research with medicinal products will be submitted via CTIS.

EU Medical Device Regulation (MDR)

On May 26, 2021, the EU Medical Device Regulation 2017/745 (MDR) has come into effect with specific rules for the submission, review and conduct of clinical investigations with medical devices.

News

CTA template will save time

27-02-2025 | 11:37

From 27 February 2025 , the new template Clinical Trial Agreement (CTA) is also available on the CCMO website in English. All ...

CCMO launches Research Portal

03-02-2025 | 12:04

On 3 February 2025 CCMO launched the Research Portal. This new portal, which replaces ToetsingOnline, is designed to make life ...

Temporary hold new requests scientific advice

21-01-2025 | 13:39

The pilot Scientific Advice CCMO is currently on hold since the maximum of ten requests for scientific advice has been reached. ...

Last opportunity for expedited administrative procedure for handling a transitional clinical trial

20-01-2025 | 18:02

From 31 January 2025, the Clinical Trial Regulation (CTR, EU no 536/2014) will apply to all clinical trials with a medicinal ...

Availability CCMO during festive season

28-11-2024 | 10:19

Between December 23, 2024, and January 6, 2025, the CCMO will not be available by telephone. Due to the festive season, CCMO will ...

Template research protocol amended

26-11-2024 | 16:50

The template research protocol has been changed, due to the upcoming replacement of ToetsingOnline by the new Research Portal on ...
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