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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, ...
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From October 2020, CCMO will meet twice a month
As of October 2020, CCMO will hold two meetings a month instead of one.
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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 ...
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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 ...
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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 ...
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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 ...
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Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
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Flowcharts deferred consent for medical research in emergency situations
CCMO has drawn up flowcharts to clarify when and if medical research involving subjects is allowed to take place in emergency ...
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MDR postponed by one year to 26 May 2021
The moment of ratification of the European Medical Device Regulation (EU no 2017/745 (MDR)) has been postponed by one year due to ...
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European Commission agrees to postpone MDR by one year
Due to the corona crisis, the European Commission has accepted the proposal to postpone the commencing date of the European ...