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 ...
15-12-2020 | 14:09
A new version of the Investigational Medical Device Dossier (IMDD) template is available. This version is an update of the ...
05-11-2020 | 15:55
From 1 December 2020, the procedure for submitting a declaration of local feasibility for medical research will be modified. In ...
22-10-2020 | 15:13
As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. A new guidance sets out the implications for the ...
16-10-2020 | 14:27
A new template for the Subject Information Sheet (SIS) for subjects aged 16 and over (adults) is now available on the CCMO ...
01-10-2020 | 15:20
From 1 October 2020, CCMO will be the competent authority for clinical investigations involving medical devices. From that date, ...
11-09-2020 | 15:16
Starting 1 October 2020, CCMO will be the competent authority for clinical investigations with medical devices. This means that ...
11-09-2020 | 10:00
As of October 2020, CCMO will hold two meetings a month instead of one.
03-09-2020 | 15:46
CCMO has decreed that the submission of a human subject insurance statement to the review committee in the case of a research ...
25-08-2020 | 15:36
As of 25 August 2020, the conditions for (re)starting clinical research in clinical research units (CRUs) are the same as those ...
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 ...
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 ...
17-06-2020 | 09:34
The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to ...
26-05-2020 | 13:24
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 ...
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 ...
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 ...
03-04-2020 | 15:44
Due to the exceptional circumstances, the Ministry of Infrastructure and Water Management (IenW) has decided to accelerate the ...
