Oct 31, 2022 · Hi Experts, Can someone please share a gap analysis or a consolidated EU MDR GSPR and TGA Essential Principles checklist? Thank you. medwise

Mar 22, 2019 · Good Morning, I was wondering how everyone else is interpreting the beginning paragraph of GSPR 23.1 (See below). We had in external trainer tell us this had to be the IFU, …

Sep 22, 2020 · Hi, I saw someone asked for this before, but I am looking for a table/template for the MDR GSPR that is free. Thanks!

Jun 7, 2021 · This is from a publication by BSI on GSPR: "SPRs 10.4.3 and 10.4.4 state that the European Commission shall provide the scientific committee provided for in the Regulation …

Mar 4, 2021 · Agreed. For sure 1 and 8 since they are specifically mentioned in MDR Article 61.1. And via the mention of "relevant" GSPRs that leaves the door open for other GSPRs as well. …

Jun 3, 2024 · Hello, we just received the comments from our notified body for the MDR submission of our Medical device software and we have a NC concerning the GSPR 6 …

Jan 9, 2025 · GSPR 6 is specifically about degradation of performance over the life of the device. This would be quite difficult to show through clinical data unless you have a study that …

Oct 20, 2020 · Hi all I'm wrestling with the interpretation of the MDR GSPR 23.4 (u) where a requirement in the IFU is that "in the case of implantable devices, the overall qualitative and …

Jun 4, 2020 · Hello everyone, I am struggling at the moment with one General Safety and Performance Requirement while updating the Technical Documentation for a product. In …

Aug 2, 2024 · Hi all, could someone share Annex ZZ from EN 60601-1:2006+A1+A12+A2+A13:2024 here? :) Annex ZZ (informative) Relationship between this …