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