►Medboard: [ Ссылка ]

EU
■Urgent update needed - EU MDR and IVDR: [ Ссылка ]
o HMA communication: [ Ссылка ]

■EU Commission Newsletter - What are the hot news: [ Ссылка ]

■MDCG 2021-25 ;legacy devices & devices placed on the market prior to 26 May 2021: [ Ссылка ]
o Blog post article: [ Ссылка ]

■Notified Bodies Overview - How many still remaining: [ Ссылка ] cument/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf
o New MDR NEOEMKI in Bulgaria: [ Ссылка ]

■HPRA Notification for In-house Manufacturers - Frequently Asked Questions: [ Ссылка ]

■ Harmonized Standards Summary List - For MDR and IVDR:
o MDR: [ Ссылка ]
o IVDR: [ Ссылка ]

■MDCG 2024-11 - Qualification of IVDR: [ Ссылка ]

■PMS is not implemented correctly - IGJ report is shocking: [ Ссылка ]
o Blog post: [ Ссылка ]

■EUDAMED in Turkey - Message: You should use it: [ Ссылка ]

■Turkey registration limited - 10 per individual: [ Ссылка ]

■UK Post-Market Surveillance - New amendment: [ Ссылка ]

Training:
■Team-NB training on Technical Documentation- November 6th: [ Ссылка ]

Events:
■MedtechConf events - Check the MAP
o Afrisummit 2024 in Cairo November 3 to 6: [ Ссылка ]
o MEDxD 2024 In Berlin November 7th: [ Ссылка ]
o Medica 2024 in Dusseldorf November 11th: [ Ссылка ]

ROW
Australia:
■What is a Personalized Medical Device? - In Australia: [ Ссылка ]

■How to submit a notification on custom-made device in Australia: [ Ссылка ]

Mexico
■GMP for Mexico - Draft document: [ Ссылка ]

South Africa
■South Africa and Australia MoU - Harmonization is on the way: [ Ссылка ]

PODCAST
Podcast Nostalgia - Let's review
■ Episode 306 - What are the TOP 3 issues on CAPA with Georg Digel: [ Ссылка ]
■ Episode 307 - What does a strategy for Regulatory Compliance Look like? [ Ссылка ]

► Social Media to follow

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

#easymedicaldevice #medicaldevice #regulatorycompliance

00:00 Introduction
01:01 Urgent update needed
03:41 EU Commission Newsletter
04:30 MDCG 2021-25
05:24 Notified Bodies Overview
07:10 HPRA Notification for In-house Manufacturers
08:18 Harmonized Standards Summary List
09:04 MDCG 2024-11
09:53 PMS is not implemented correctly
11:53 EUDAMED in Turkey
12:41 Turkey registration limited
14:17 UK Post-Market Surveillance
16:03 Team-NB training on Technical Documentation
16:38 MedtechConf events
17:55 What is a Personalized Medical Device?
19:40 South Africa and Australia MoU
20:41 Podcast Nostalgia
21:52 Conclusion

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