Important Updates to SAE Reporting in Europe
June 10 2010
Directive 2007/47/EC came into force on 21st March 2010, amending the Medical Device Directive 93/42/EEC and the Vitro Diagnostic Directive 98/79/EC. One of the changes concerns serious adverse event (SAE) reporting, whereby all SAE's now need to be reported to all Competent Authorities where a clinical investigation is taking place.
Further changes are also afoot, as a new guidance document is expected to be published in June, which has been developed by Eucomed and the Commision's clinical investigation and evaluation working group. The reporting requirements will not only be relevant to devices used in clinical investigations which are not CE marked, but they may also apply to comparator products. It's anticipated that the responsibility for reporting will reside with the sponsor (and not the manufacturer of the comparator product). There is also a possibility that the requirements may be enforced for investigations which are already on going at the time of implementation.