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Evaluation procedure VGO local feasibility started

Since December 1, 2020, sponsors can choose whether to use the Site Suitability Declaration (Verklaring Geschiktheid ...

News item | 30-03-2021 | 15:20

Clinical Trial Regulation expected to apply from January 31, 2022

The European Medicines Agency (EMA) has announced a new expected go-live date of the Clinical Trials Information System (CTIS): ...

News item | 18-03-2021 | 16:52

Risk inventory important for conduct of clinical research

Yesterday, the cabinet declared a lockdown to reduce the spread of the coronavirus. In response to this, CCMO would like to draw ...

News item | 15-12-2020 | 14:52

New version Investigational Medical Device Dossier (IMDD) template available

A new version of the Investigational Medical Device Dossier (IMDD) template is available. This version is an update of the ...

News item | 15-12-2020 | 14:09

From 1 December 2020 modified procedure for submitting local feasibility declaration

From 1 December 2020, the procedure for submitting a declaration of local feasibility for medical research will be modified. In ...

News item | 05-11-2020 | 15:55

Guidance for MRECs on medical device investigations

As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. A new guidance sets out the implications for the ...

News item | 22-10-2020 | 15:13

New Subject Information Sheet for adults now available

A new template for the Subject Information Sheet (SIS) for subjects aged 16 and over (adults) is now available on the CCMO ...

News item | 16-10-2020 | 14:27

Register medical devices investigations with CCMO? Online tool offers a solution

From 1 October 2020, CCMO will be the competent authority for clinical investigations involving medical devices. From that date, ...

News item | 01-10-2020 | 15:20

Notifications of clinical investigations with medical devices to CCMO as of 1 October

Starting 1 October 2020, CCMO will be the competent authority for clinical investigations with medical devices. This means that ...

News item | 11-09-2020 | 15:16

From October 2020, CCMO will meet twice a month

As of October 2020, CCMO will hold two meetings a month instead of one.

News item | 11-09-2020 | 10:00