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

Click here for the full article on Global Regulatory Press.

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Europe - May 2020

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EU: MDR delayed to 26 May 2021

Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in getting essential medical devices needed to combat Covid-19. The

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