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CTR: EU regulation on clinical trials with medicinal products

From January 31, 2023, all initial clinical trial applications will be submitted via CTIS. Read more on the Clinical Trial Regulation (CTR).
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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

Template Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) available

15-09-2023 | 15:07

From September 15, 2023, the template Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) is available on the ...

New version available of the CCMO Directive on the assessment of site suitability

16-08-2023 | 15:05

The new version of the CCMO Directive on the assessment of the suitability of research centres ( Toetsing geschiktheid ...

Modification of study data in LTR possible from 15 May 2023

15-05-2023 | 16:39

From 15 May 2023, it will be possible to change data of studies previously registered in the National Trial Register (NTR). These ...

CCMO develops patient-friendly Subject Information Sheet (SIS)

21-03-2023 | 00:00

CCMO considers an accessible SIS for both participants and researchers to be of great importance. Therefore, CCMO has started the ...

Revision of the Site Suitability Declaration (VGO)

23-02-2023 | 10:22

The Dutch Clinical Research Foundation (DCRF) has revised the Site Suitability Declaration (VGO). The aim of this revision is to ...

Patient participation in the research file from 1 March 2023

05-01-2023 | 16:10

As part of its Patient Participation programme, CCMO has developed a set of questions on patient participation that will be ...
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