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 ...
New version Investigational Medical Device Dossier (IMDD) template available
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 ...
From 1 December 2020 modified procedure for submitting local feasibility declaration
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 ...
Guidance for MRECs on medical device investigations
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 ...
New Subject Information Sheet for adults now available
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 ...
Register medical devices investigations with CCMO? Online tool offers a solution
01-10-2020 | 15:20
From 1 October 2020, CCMO will be the competent authority for clinical investigations involving medical devices. From that date, ...
Notifications of clinical investigations with medical devices to CCMO as of 1 October
11-09-2020 | 15:16
Starting 1 October 2020, CCMO will be the competent authority for clinical investigations with medical devices. This means that ...
From October 2020, CCMO will meet twice a month
11-09-2020 | 10:00
As of October 2020, CCMO will hold two meetings a month instead of one.
Immediate annulment of the human subject insurance statement
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 ...
Conditions for (re)starting clinical research in healthcare institutions and CRUs aligned
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 ...
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 ...
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 ...
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 ...