Manufacturer Incident Report + MDR consolidated version

Please be aware that there were new/updated forms published on the Commission website with regard to incident reporting:

  • Manufacturer incident report 2020 (Form)
  • Manufacturer incident report for importing XML file with Adobe Professional 2020 (Form)
  • Changelog file 2020


For easier reviewing of the recently modified MDR provisions, we suggest you to consult the text of the MDR consolidated version published in EUR-LEX. And to better navigate through complex deadlines and to reach compliance by 2021, we invite you to purchase the below MDlaw guidance documents, which were recently updated to reflect the new MDR date of application:

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