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The EU Clinical Trial Regulation (CTR) makes the review of clinical trials a joint responsibility of all EU Member States.

The EU regulations for medical devices and in vitro diagnostics will apply in 2020 and 2022 respectively.

20-12-2019 | 11:29

As of May 26th 2020, the European Medical Device Regulation (EU) 2017/745 (MDR) comes into effect. The MDR brings new rules for ...

20-09-2019 | 16:35

For investigator-initiated research, a special template is now available for the clinical trial agreement.

20-09-2019 | 10:25

An update of the Investigational Medical Device Dossier (IMDD) is available.

29-07-2019 | 15:32

Sponsors are required to publish results of research subject to the WMO (Medical Research involving Human Subjects Act) in ...

22-07-2019 | 09:55

The CCMO as competent authority currently has a delay in reviewing substantial amendments.

21-05-2019 | 13:29

From today, the signed version of the clinical trial agreement (CTA) may be submitted to the review committee (accredited MREC or ...