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.
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, ...