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 ...
18-05-2021 | 11:21
CCMO’s website clarifies when CCMO is the designated review committee for certain types of research.
22-04-2021 | 16:28
The European Medicines Agency (EMA) has confirmed that the development of the Clinical Trials Information System (CTIS) is on ...
30-03-2021 | 15:20
Since December 1, 2020, sponsors can choose whether to use the Site Suitability Declaration (Verklaring Geschiktheid ...
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): ...
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 ...
