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75 news items
Information EU Medical Device Regulation available on CCMO website
On May 26, 2021, the EU Medical Device Regulation (EU no 2017/745, MDR) has come into effect. The MDR contains specific rules for ...
CCMO reviews research on cell therapy, gene therapy, other products that specifically influence the functioning of the genetic material and medicinal products with GMO
CCMO’s website clarifies when CCMO is the designated review committee for certain types of research.
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 ...