News - Latest

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Conditions for (re)starting clinical research

   The Health and Youth Care Inspectorate (IGJ) has published a document with the conditions for the (re)start of clinical research ...

   News item | 25-06-2020 | 17:19

10. Clinical Trial Regulation expected to apply from December 2021

    The European Medicines Agency (EMA) has announced that the EU portal ‘Clinical Trials Information System’ (CTIS) is expected to ...

    News item | 17-06-2020 | 09:34