Here is your Medical Device Regulatory update. This will be focused on the IVDR 2017/746 that went live. So let's update you on some key changes.

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► 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 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, podcasts, online courses...

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► Links from the Video
NEWS
- Swiss: MRA situation for IVDR; [ Ссылка ]
- Swiss: new IvDV (Ordinance on in-vitro diagnostics): [ Ссылка ]
○ Swiss Odiv: [ Ссылка ]
- Swiss: Performance studies of IVD: [ Ссылка ]
○ [ Ссылка ]
- EU: Team NB Survey: [ Ссылка ]
- EU: Harmonized standard for IVDR: [ Ссылка ]
- EU: Harmonized standard for MDR: [ Ссылка ]
- Italy: Establishment of the National Surveillance Network: [ Ссылка ]
- Preparing for UKCA marking of Medical Device with Ronald Boumans: [ Ссылка ]
- Green Belt Certification June 2022: [ Ссылка ]

NOTIFIED BODY
- 3EC International - IVDR 2017/746 - [ Ссылка ]
- TÜV Nord - EU MDR 2017/745: [ Ссылка ]
- Berlin Cert - EU MDR [ Ссылка ]
- Overview NB each stage: [ Ссылка ]

GUIDANCE
- MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR: [ Ссылка ]
- MDCG 2022-7 Q&A UDI System: [ Ссылка ]
- MDCG 2022-8 IVD Legacy devices: [ Ссылка ]
- MDCG 2022-9 Summary of safety and performance template: [ Ссылка ]
- MDCG 2022-10 Q&A interface 536/2014 on clinical trials for medicinal products for human use and IVDR: [ Ссылка ]

PODCAST
- Episode 179 - How to certify your Software as a Medical Device? With Vivek Thakkar: [ Ссылка ]
- Episode 180 - What happens after the IVDR Date of Application with Colm O'Rourke: [ Ссылка ]
- Episode 181 - What to learn about the EU Medical Device Situation? [ Ссылка ]
Episode 182- Let's introduce our eQMS Smarteye with Anindya Mookerjea: [ Ссылка ]

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► Social Media to follow

■ Monir El Azzouzi Linkedin: [ Ссылка ]
■ Twitter: [ Ссылка ]
■ Pinterest: [ Ссылка ]
■ Instagram: [ Ссылка ]

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