MDCG 2022-18 – MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate. As I am sure you are already aware, the new Article 97 basically allows…
SwissMedic has raised a new FAQ document regarding the registration of Medical Devices on the Swiss Market. Some of the answers may surprise you! Download a copy here:- file:///C:/Users/Martin/AppData/Local/Temp/MicrosoftEdgeDownloads/e5949b5e-8c43-42a3-a550-46d2320cfd21/BW630_30_009e_MB_FAQ_Notifications.pdf
Did you know ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, is a companion document to the globally recognized risk management standard ISO 14971, Medical devices – Application of risk management to medical devices. The ISO standard, which was updated in…
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