Medical Device News November 2024 Regulatory Update

Medboard

https://www.medboard.com/

 

EU

• Urgent update needed – EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf

• HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf

• EU Commission Newsletter – What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56793

• MDCG 2021-25 ;legacy devices & devices placed on the market prior to 26 May 2021: https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf

• Blog post article: https://easymedicaldevice.com/legacy-devices-clarification-with-mdcg-2021-25/

• Notified Bodies Overview – How many still remaining: https://health.ec.europa.eu/do cument/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf

• New MDR NEOEMKI  in Bulgaria: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=0e4e49a1afef458542254b3556a5e83d85321b23&group=NOTIFICATION&download=true

• HPRA Notification for In-house Manufacturers – Frequently Asked Questions: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/sur-g0053-faq-on-notification-for-in-house-manufacturers-of-medical-devices-and-in-vitro-diagnostic-medical-devices-v1.pdf?sfvrsn=8

• Harmonized Standards Summary List – For MDR and IVDR:

• MDR: https://ec.europa.eu/docsroom/documents/62156/attachments/1/translations/en/renditions/native

• IVDR: https://ec.europa.eu/docsroom/documents/62158/attachments/1/translations/en/renditions/native

• MDCG 2024-11 – Qualification of IVDR: https://health.ec.europa.eu/document/download/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf

• PMS is not implemented correctly – IGJ report is shocking: https://english.igj.nl/binaries/igj-en/documenten/publication/2024/10/08/call-to-medical-device-manufacturers-implement-an-effective-pms-system/20241003_Call+to+medical+device+manufacturers+implement+effective+PMS+system.pdf

• Blog post: https://easymedicaldevice.com/how-can-i-do-my-post-market-surveillance/

• EUDAMED in Turkey – Message: You should use it: https://titck.gov.tr/duyuru/tcokka-tibbi-cihazlara-iliskin-avrupa-veri-tabani-hakkinda-teblig-taslagina-iliskin-duyuru-11102024094328

• Turkey registration limited – 10 per individual: https://titck.gov.tr/duyuru/tibbi-cihaz-belge-ve-urun-kaydi-yapan-firma-ve-kullanicilarina-iliskin-duyuru-07102024151251

• UK Post-Market Surveillance – New amendment: https://www.legislation.gov.uk/ukdsi/2024/9780348264593/data.pdf

 

Training

• Team-NB training on Technical Documentation-  November 6th: https://www.team-nb.org/wp-content/uploads/2024/07/Leaflet-MDR-TD-Manufacturers-Training-20241106.pdf

 

Events

MedtechConf events – Check the MAP

• Afrisummit 2024 in Cairo November 3 to 6: https://medtechconf.com/event/afrisummit/
• MEDxD 2024 In Berlin November 7th: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/
• Medica 2024 in Dusseldorf November 11th: https://medtechconf.com/event/medica-2024/

 

ROW

Australia

•  What is a Personalized Medical Device? – In Australia: https://www.tga.gov.au/sites/default/files/2024-10/understanding-personalised-medical-devices%20rules-including-3d-printed%20devices.pdf
• How to submit a notification on custom-made device in Australia: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf

Mexico

GMP for Mexico – Draft document: https://www.dof.gob.mx/nota_detalle.php?codigo=5734591&fecha=26/07/2024#gsc.tab=0

 

South Africa

• South Africa and Australia MoU – Harmonization is on the way: https://www.sahpra.org.za/news-and-updates/south-african-and-australian-health-product-regulators-to-share-regulatory-information-and-expertise/

 

PODCAST

Podcast Nostalgia  – Let’s review

• Episode 306 – What are the TOP 3 issues on CAPA with Georg Digel: https://podcast.easymedicaldevice.com/306-2/
• Episode 307 – What does a strategy for Regulatory Compliance Look like? https://podcast.easymedicaldevice.com/307-2/

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

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