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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