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.
Information EU Medical Device Regulation available on CCMO website
20-05-2021 | 10:59
On May 26, 2021, the EU Medical Device Regulation (EU no 2017/745, MDR), will come into effect. The MDR contains specific rules ...
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 ...
Clinical Trial Regulation expected to apply from January 31, 2022
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): ...
Risk inventory important for conduct of clinical research
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 ...