Europe - February 2018

  • EU: Codes and corresponding device types, application forms, and application documentation for Notified Body designation

  • EU: Conditions for the exemption of reused spare parts recovered from EEE

  • EU: Publication of new list of harmonised European standards, including EN ISO 13485:2016, EN ISO 15223-1:2016 and EN ISO 14155:2011/AC:2011

  • EU: Manual on borderline and classification issues updated

  • EU: FAQ documents address transitional provisions of the MDR and IVDR

  • EU: IMDRF adverse event reporting terminology to be utilised in Europe

  • Finland: First phase of legislative changes to implement new European Regulations on medical devices and IVDs

  • Switzerland: Process of aligning Swiss medical device legislation with the new European Regulations begin

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