Information CCMO due to coronavirus outbreak
Here you will find our news items following the coronavirus outbreak.
EU Medical Device Regulation (MDR) and IVD Regulation (IVDR)
The EU regulations for medical devices and in vitro diagnostics will apply in 2021 and 2022 respectively.
New directive makes use of Site Suitability Declaration (VGO) obligatory for research with a medicinal product as of 1 November 2021
18-10-2021 | 09:00
CCMO’s directive on the assessment of the suitability of research centres (TGO) has been adopted and will apply to studies with ...
Rates established for assessment of research under CTR and MDR
17-09-2021 | 11:13
The Ministry of Health, Welfare and Sport has set the rates for medical ethical review in the Netherlands of research under the ...
Clinical Trial Regulation (CTR) applicable from 31 January 2022, VHP concludes on 15 October 2021
04-08-2021 | 10:38
On 31 July, the European Commission has announced in the Official Journal of the European Union that the Clinical Trial ...
Site Suitability Declaration (VGO) as of 1 November 2021 obligatory for research with a medicinal product
09-07-2021 | 14:55
As of 1 November 2021, use of the Site Suitability Declaration [Verklaring Geschiktheid Onderzoeksinstelling, VGO] will become ...
Changes in CCMO's assessment task for specific types of research
29-06-2021 | 16:36
CCMO’s assessment task has been adapted for specific types of research. These adaptations have been laid down in the Dutch ...
Information EU Medical Device Regulation available on CCMO website
24-06-2021 | 17:06
On May 26, 2021, the EU Medical Device Regulation (EU no 2017/745, MDR) has come into effect. The MDR contains specific rules for ...