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ToetsingOnline will become Research Portal on 3 February 2025

Click on this link for information on the transition to the new Research Portal

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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

CCMO postpones launch new Research Portal until 3 February

03-10-2024 | 11:24

The CCMO has decided to postpone the introduction of the new Research Portal. The system replacing ToetsingOnline was supposed to ...

Information on transition to new Research Portal available on CCMO website

03-09-2024 | 00:00

In early December 2024 CCMO will adopt a new portal for submitting medical scientific research. All information about the ...

Rates 2025: assessment of research under CTR, MDR and IVDR

02-07-2024 | 16:14

The Ministry of Health, Welfare and Sport has set the rates for 2025 for medical ethical review in the Netherlands of research ...

Template research protocol (WMO): explanation 'Safety' extended

09-04-2024 | 13:58

The template research protocol has been modified on two minor points. The changes only serve to clarify the submission process. ...

CCMO starts pilot scientific advice on 8 April 2024

19-03-2024 | 18:43

On 8 April 2024, the CCMO will start a pilot evaluating the feasibility of providing scientific advice as a new task of the CCMO. ...

News on public research data: LTR becomes OMON, ToetsingOnline data included and OMON WHO-approved data provider

05-03-2024 | 16:13

The development of the Dutch Trial Register (LTR) is an ongoing process. Below, you may find more information on the recent name ...
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