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Medical Device News – November 2021 latest update

In this episode of the Podcast we will review:
– IVDR proposal to delay transition periods
– Cobalt on medical devices as CMR
– Artificial Intelligence
– MDCG guidance
– Notified Body overview

► Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create 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, podcasts, Online courses…

► Links from the Video

• Implementing Rolling Plan
• IVDR proposal for new transition period:
• PDF Q&A:
• Draft Regulation:
• ANSM: From October 1st 2021 Cobalt as CMR following 2020/2017:
• Listed on CLP 1272/2008 Annex VI:
• Guideline to justify CMR is called SCHEER which provides elements to justify with benefit/risk analysis.
• TEAM NB – Proposal for Notified Body Opinion Template for Article 117:
• TEAM NB – European Artificial Intelligence:
• UK MHRA – US, Canada and UK identified 10 guiding principles for AI softwares
• UK MHRA – Consultation on Futur Regulation
• UK MHRA – Infusion Pump T34 from BD
• MHRA Board meeting held in public – eventbrite:
• Turkey
○ EU MDR 2017/745 – May 2021
○ EU IVDR 2017/746 – Sept 2021
• Philippine – FDA Circular for retailers of Medical Devices – License to sell medical devices is needed
• Thailand FDA – HAS Singapore – Regulatory reliance program:
• Japan – PMDA update
○ Online platform to learn the regulation in Japan:
○ Other course:

• ACRAS – Nov 24th and 25th

• Overview of Notified Body Situation

• MDCG 2021-24 – Classification
• MDCG 2021-25 Legacy devices
• MDCG 2021-26 Article 16 Importer Distr Q&A

• Episode 149 – EUDAMED Update with Richard Houlihan
• Episode 150 – CMR substances with Ana Luiza Cassin Duz
• Episode 151 – IVDR is not postponed with Erik Vollebregt

#EasyMedicaldevice #medicaldevices #compliance


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