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E1/E2. Template Subject Information Sheet (English)
Flowchart Adverse events research with a medical device
E1/E2. Template Subject Information Sheet (Dutch)
Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
Decree 2014 containing rules for compulsory insurance in medical research involving human subjects and explanatory memorandum
Review of a clinical investigation with a medical device – guidance document for MRECs
As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. This guidance sets out the implications for the ...