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.
CCMO office closed on 24 September 2020
22-09-2020 | 08:43
Due to the annual staff outing, the CCMO office is closed on Thursday 24 September 2020.
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 ...