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.
Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
26-05-2020 | 13:24
Conditions for (re)starting studies in clinical research units
19-05-2020 | 15:08
CCMO has published a document on the conditions for the (re)start of studies in clinical research units.
Flowcharts deferred consent for medical research in emergency situations
12-05-2020 | 16:27
CCMO has drawn up flowcharts to clarify when and if medical research involving subjects is allowed to take place in emergency ...
MDR postponed by one year to 26 May 2021
24-04-2020 | 13:31
The moment of ratification of the European Medical Device Regulation (EU no 2017/745 (MDR)) has been postponed by one year due to ...
European Commission agrees to postpone MDR by one year
03-04-2020 | 17:35
Due to the corona crisis, the European Commission has accepted the proposal to postpone the commencing date of the European ...
Emergency regulation for authorisation of research into COVID-19-targeted gene therapy or medicinal product containing GMO
03-04-2020 | 15:44
Due to the exceptional circumstances, the Ministry of Infrastructure and Water Management (IenW) has decided to accelerate the ...