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Medical Device News – April 2021 Update [EU MDR & IVDR]



Let’s update you on the Medical Device situation. In this episode we will talk about:

  • Countdown until date of application of EU MDR
  • Swixit with a negociation ongoing
  • MDCG guidance planning
  • Easy Medical Device services
  • Notified Body overview
  • UK Approved Body overview
  • EU commission guidance on SaMD
  • MDCG 2021-2 on Covid-19 Rapid test
  • MDCG 2021-3 on Custom-made devices
  • Easy Medical Device Podcast
  • Easy Medical Device Live sessions

See below the links for each of the topics.

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…


  • MDCG planning (Q2 2021): https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_ongoing_guidancedocs_en.pdf
  • TEAM-NB Swixit MRA amendment: https://www.team-nb.org/wp-content/uploads/2021/03/Message-EU-Switzerland-MRA-Information-from-the-Commission.pdf
  • Notified Body Overview: https://ec.europa.eu/health/sites/health/files/md_newregulations/docs/notifiedbodies_overview_en.pdf
  • Is your Software a Medical Device? : https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2021_mdsw_en.pdf
  • MDCG 2021-2: Guidance on State-of-the-Art of Covd19 rapid antibody test: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-2_en.pdf
  •  MDCG 2021-3: Questions and Answers on Custom-Made devices: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-3_en.pdf
  • Episode 118 – How to import your Medical Devices with an independent importer? Edgar Kasteel Medenvoy https://podcast.easymedicaldevice.com/118/
  • Episode 119 – How System and Procedure Pack are regulated under EU MDR – Erik Vollebregt https://podcast.easymedicaldevice.com/119/
  • Episode 120 – How to create a Label under MDR? https://podcast.easymedicaldevice.com/120/
  • Episode 121 – Is it difficult time for an IVD manufacturer? https://podcast.easymedicaldevice.com/121/
  • EUDAMED legacy devices: https://youtu.be/ZXg-Maz3aUM
  • Create your Basic UDI-DI and UDI-DI with GS1: https://youtu.be/_kF5GUs_hgo
Medical Device News April 2021 Update

The post Medical Device News – April 2021 Update [EU MDR & IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Helping you placing compliant medical device on the market.

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