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Availability CCMO during holiday season

Due to the holiday season CCMO’s availability is reduced from Monday 21 December 2020 up to and including Friday 1 January 2021. ...

News item | 01-12-2020 | 10:48

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

Brexit and clinical research

The United Kingdom (UK) has left the European Union (EU) on 31 January 2020. A transitional period is now in place until 31 ...

News item | 09-07-2020 | 12:16