In this video, the following question is briefly answered:
“How do clinical investigations under article 82 comply with safety reporting in The Netherlands?”
Last week, we began looking at safety reporting. Today, we’re going to briefly focus on the following follow-up question:
How do clinical investigations under article 82 comply with safety reporting in The Netherlands?
According to the CCMO, all clinical investigations that are subject to the MDR article 82 must continue to follow the rules outlined in Article 10 of the WMO, the Dutch Act on Medical Research. This means, all reportable serious adverse events need to be reported. If the investigations have had a positive decision prior to 26 May 2021 and they are subject to Article 82 of the MDR, then this procedure applies to those studies as well.
It is important to note that some definitions between the WMO and MDR are slightly different.
Further definitions and explanations of these differences and how reporting needs to be done can be read in next month’s article on safety reporting.