October 2024 WMA issued a new version of the Declaration of Helsinki. Most striking changes include:
Lees meerUnder MDR Ethics Committees nowadays typically ask for a clinical evaluation plan when submitting for review of a clinical investigation. During the last ACS CRA meeting we discussed that this does not concern a new document but rather an exisiting document which is part of the Product Technical File. Below you find the concerning presentation. […]
Lees meerhttps://www.iso.org/standard/83968.html A new version of ISO14155 is currently under development, and on 20-JUN-2024 ISO/DIS 14155, replacing ISO14155:2020 when ready, entered the voting phase that terminates on 12-SEP-2024. A couple of interesting elements are in (potentially) impacting riskmanagement and safety for medical device clinical investigations (note the scope seems to have widened no longer excluding IVDs), […]
Lees meerEU commission issues an updated planning for gradual roll out of the EUDAMED modules, however, the timeline for delivery of the clinical investigations / performance studies module has been set yet. In other words we are still stuck with local approaches when it comes to adverse event reporting to the regulatory bodies involved in clinical […]
Lees meerThe MDCG issued guidance regarding the content and the synopsis of the Clinical Investigation Plan (CIP) for Medical Device studies. A quick review learns there are no big surprise here: to name a few.
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