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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