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.
Brexit and clinical research
09-07-2020 | 12:16
The United Kingdom (UK) has left the European Union (EU) on 31 January 2020. A transitional period is now in place until 31 ...
Conditions for (re)starting clinical research
25-06-2020 | 17:19
The Health and Youth Care Inspectorate (IGJ) has published a document with the conditions for the (re)start of clinical research ...
Clinical Trial Regulation expected to apply from December 2021
17-06-2020 | 09:34
The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to ...
Conditions for (re)starting studies in clinical research units
10-06-2020 | 15:08
CCMO has published a document on the conditions for the (re)start of studies in clinical research units.
Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
26-05-2020 | 13:24
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 ...