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Risk inventory important for conduct of clinical research

Yesterday, the cabinet declared a lockdown to reduce the spread of the coronavirus. In response to this, CCMO would like to draw ...

News item | 15-12-2020 | 14:52

New version Investigational Medical Device Dossier (IMDD) template available

A new version of the Investigational Medical Device Dossier (IMDD) template is available. This version is an update of the ...

News item | 15-12-2020 | 14:09

From 1 December 2020 modified procedure for submitting local feasibility declaration

From 1 December 2020, the procedure for submitting a declaration of local feasibility for medical research will be modified. In ...

News item | 05-11-2020 | 15:55

Guidance for MRECs on medical device investigations

As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. A new guidance sets out the implications for the ...

News item | 22-10-2020 | 15:13

New Subject Information Sheet for adults now available

A new template for the Subject Information Sheet (SIS) for subjects aged 16 and over (adults) is now available on the CCMO ...

News item | 16-10-2020 | 14:27

Register medical devices investigations with CCMO? Online tool offers a solution

From 1 October 2020, CCMO will be the competent authority for clinical investigations involving medical devices. From that date, ...

News item | 01-10-2020 | 15:20

Notifications of clinical investigations with medical devices to CCMO as of 1 October

Starting 1 October 2020, CCMO will be the competent authority for clinical investigations with medical devices. This means that ...

News item | 11-09-2020 | 15:16

From October 2020, CCMO will meet twice a month

As of October 2020, CCMO will hold two meetings a month instead of one.

News item | 11-09-2020 | 10:00

Immediate annulment of the human subject insurance statement

CCMO has decreed that the submission of a human subject insurance statement to the review committee in the case of a research ...

News item | 03-09-2020 | 15:46

Conditions for (re)starting clinical research in healthcare institutions and CRUs aligned

As of 25 August 2020, the conditions for (re)starting clinical research in clinical research units (CRUs) are the same as those ...

News item | 25-08-2020 | 15:36