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Clinical Trial Regulation to apply from January 31, 2022
The European Medicines Agency (EMA) has confirmed that the development of the Clinical Trials Information System (CTIS) is on ...
Evaluation procedure VGO local feasibility started
Since December 1, 2020, sponsors can choose whether to use the Site Suitability Declaration (Verklaring Geschiktheid ...
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): ...
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 ...
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 ...
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 ...
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 ...
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 ...
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, ...
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 ...