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.
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 ...
CCMO reviews research on cell therapy, gene therapy, other products that specifically influence the functioning of the genetic material and medicinal products with GMO
18-05-2021 | 11:21
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
22-04-2021 | 16:28
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
30-03-2021 | 15:20
Since December 1, 2020, sponsors can choose whether to use the Site Suitability Declaration (Verklaring Geschiktheid ...