Share your views: Draft guidance on how to interpret ‘significant change’ of a medical device From Health Canada 🇨🇦 Health Canada has updated the Guidance on how to interpret ‘significant change’ of a medical device. This guidance: • helps manufacturers determine when a change made to a device is significant • explains the concepts that manufacturers must apply when making this determination • provides many… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 7, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Draft guidance on how to interpret ‘significant change’ of a medical device: Overview From Health Canada 🇨🇦 This guidance document has been updated to expand on the definition of “significant change” in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 7, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD From European Commission 🇪🇺 Document provides guidance on significant changes related to transitional provision under Article 120 of the MDR for devices covered by MDD or AIMDD certificates, focusing on Notified Bodies. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Substantial modification of performance study under Regulation (EU) 2017/746 From European Commission 🇪🇺 This document discusses the significant changes made to performance studies for In Vitro Diagnostic medical devices (IVD) under Regulation (EU) 2017/746. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR From European Commission 🇪🇺 Guidance on significant changes to transitional provision under Article 110(3) of IVDR for In Vitro Diagnostic medical devices (IVD). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Substantial modification of clinical investigation under Medical Device Regulation From European Commission 🇪🇺 Learn about the significant changes in clinical investigation under the Medical Device Regulation. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance for the Interpretation of Significant Change of a Medical Device From Health Canada 🇨🇦 2003 (revised 2011) Health Canada guidance document Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 24, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites