Here you will find our information following the coronavirus outbreak (COVID-19).
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Here you will find our news items following the coronavirus outbreak.
The EU regulations for medical devices and in vitro diagnostics will apply in 2021 and 2022 respectively.
The EU Clinical Trial Regulation (CTR) makes the review of clinical trials a joint responsibility of all EU Member States.
30-03-2021 | 15:20
Since December 1, 2020, sponsors can choose whether to use the Site Suitability Declaration (Verklaring Geschiktheid ...
18-03-2021 | 16:52
The European Medicines Agency (EMA) has announced a new expected go-live date of the Clinical Trials Information System (CTIS): ...
15-12-2020 | 14:52
Yesterday, the cabinet declared a lockdown to reduce the spread of the coronavirus. In response to this, CCMO would like to draw ...
15-12-2020 | 14:09
A new version of the Investigational Medical Device Dossier (IMDD) template is available. This version is an update of the ...
05-11-2020 | 15:55
From 1 December 2020, the procedure for submitting a declaration of local feasibility for medical research will be modified. In ...
22-10-2020 | 15:13
As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. A new guidance sets out the implications for the ...