Europe - Mar 2019
EU: More advisory documents issued to support implementation of MDR and IVDR
EU: Manual on borderline and classification issues updated
EU: New form for medical device incident reporting by manufacturers
Serbia: Registration requirements, wholesale dealing and manufacturer obligations covered by new legislation
Serbia: New ‘Law on Medical Devices’ fully implemented; electronic submissions now accepted
Spain: Clinical investigations involving CE marked devices may now be notified to AEMPS electronically
Spain: Launch of national registry of pacemakers and ICDs
UK: MHRA issues guidance and drafts contingency legislation for a no deal scenario
UK: Guidance updated on leadless cardiac pacemaker therapy
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