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.
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 ...