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Medical Device News: December 2023 Regulatory Update
MP3•Źródło odcinka
Manage episode 387831285 series 2591977
Treść dostarczona przez Monir El Azzouzi. Cała zawartość podcastów, w tym odcinki, grafika i opisy podcastów, jest przesyłana i udostępniana bezpośrednio przez Monir El Azzouzi lub jego partnera na platformie podcastów. Jeśli uważasz, że ktoś wykorzystuje Twoje dzieło chronione prawem autorskim bez Twojej zgody, możesz postępować zgodnie z procedurą opisaną tutaj https://pl.player.fm/legal.
Medboard
- Medboard platform Sponsor of the podcast https://www.medboard.com/
EU
- EPSCO Meeting November 30th. 2023 – MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf
- Survey on Medical Devices – Study supporting the monitoring of the availability of Medical Devices on the EU Market.
- Falsification of Medical Devices – Survey result: https://act.edqm.eu/s/XcPw5MDtYe49gmj/download/CMED-Survey-Report-Final%20%281%29.pdf
- MDCG 2022-11 Rev 1 Position Paper – Call to NB to streamline the certification process https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf
- EU IVDR Technical Documentation training – TEAM-NB Survey result
- Training IVDR technical documentation February 1st, 2024: https://www.team-nb.org/wp-content/uploads/2023/11/Leaflet-IVD-TD-Manufacturers-Training-20240201.pdf
- Result on Survey of MDR training: https://www.team-nb.org/mdr-technical-documentation-training-for-manufacturers/
- DEHP Substance forbidden in Medical Devices – Extension to July 1st, 2030 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482
- Notified Bodies Situation – 2 new comers:
- UDEM Turkey 41st NB under MDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7
- Scarlett NB B.VC. 42nd NB under MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=2feeb6d10d338167081ad0cf7af6683fe760cded&group=NOTIFICATION&download=true
Switzerland
- Vigilance Reporting submission information – Update your QMS procedures: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/uebersicht-medizinprodukte/archiv/hinweis-einreichung-vigilance-meldungen-mep.html
Training EU MDR
- Training EU MDR 2017/745 – December 11th – Green Belt Certification Program for EU MDR : https://school.easymedicaldevice.com/course/gb27
Medtech Conf
- Your Medtech Conferences – Register all your Events, Training, Conferences: https://medtechconf.com/
USA
- FDA withdrawal – not anymore member of the GHWP: https://www.fda.gov/media/174142/download
- Discontinuation in the USA – Notifying FDA of a permanent discontinuation: https://www.fda.gov/media/155245/download
- Webinar on Companion Diagnostics – Oncology Drug Products used with IVD tests: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program-12122023
Canada
- Medical Device Establishment Licenses annual review – You should receive your Christmas Package: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2024.html
Saudi Arabia
- Webinar: Clinical Trials of Medical Device Requirements – Click on the link in December 12th, 2023: https://www.sfda.gov.sa/en/workshop/93098
South Africa
- Guideline on Q&A for Licensing of Medical Device Establishment – Learn how to start this activity: https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf
Brazil
- Argentina & Brazil signed a Mutual Recognition Agreement – For certificates for Medical Devices: https://www.argentina.gob.ar/noticias/anmat-y-anvisa-firmaron-el-primer-acuerdo-de-reconocimiento-mutuo-en-certificados-para
SmartEye
- eQMS for Medical Device companies – Get your Demo now: https://smart-eye.io
Podcast Nostalgia
- How to CE certify a calculator, risk score software as Medical Device? Cesare Magri: https://podcast.easymedicaldevice.com/258-2/
- How to find a predicate Device for your 510k submission? Beat Keller: https://podcast.easymedicaldevice.com/259-2/
- What is the situation regarding Digitalization in the Medtech industry? MedXD https://podcast.easymedicaldevice.com/260-2/
Easy Medical Device support – info@easymedicaldevice.com
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
The post Medical Device News: December 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
316 odcinków
MP3•Źródło odcinka
Manage episode 387831285 series 2591977
Treść dostarczona przez Monir El Azzouzi. Cała zawartość podcastów, w tym odcinki, grafika i opisy podcastów, jest przesyłana i udostępniana bezpośrednio przez Monir El Azzouzi lub jego partnera na platformie podcastów. Jeśli uważasz, że ktoś wykorzystuje Twoje dzieło chronione prawem autorskim bez Twojej zgody, możesz postępować zgodnie z procedurą opisaną tutaj https://pl.player.fm/legal.
Medboard
- Medboard platform Sponsor of the podcast https://www.medboard.com/
EU
- EPSCO Meeting November 30th. 2023 – MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf
- Survey on Medical Devices – Study supporting the monitoring of the availability of Medical Devices on the EU Market.
- Falsification of Medical Devices – Survey result: https://act.edqm.eu/s/XcPw5MDtYe49gmj/download/CMED-Survey-Report-Final%20%281%29.pdf
- MDCG 2022-11 Rev 1 Position Paper – Call to NB to streamline the certification process https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf
- EU IVDR Technical Documentation training – TEAM-NB Survey result
- Training IVDR technical documentation February 1st, 2024: https://www.team-nb.org/wp-content/uploads/2023/11/Leaflet-IVD-TD-Manufacturers-Training-20240201.pdf
- Result on Survey of MDR training: https://www.team-nb.org/mdr-technical-documentation-training-for-manufacturers/
- DEHP Substance forbidden in Medical Devices – Extension to July 1st, 2030 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482
- Notified Bodies Situation – 2 new comers:
- UDEM Turkey 41st NB under MDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7
- Scarlett NB B.VC. 42nd NB under MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=2feeb6d10d338167081ad0cf7af6683fe760cded&group=NOTIFICATION&download=true
Switzerland
- Vigilance Reporting submission information – Update your QMS procedures: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/uebersicht-medizinprodukte/archiv/hinweis-einreichung-vigilance-meldungen-mep.html
Training EU MDR
- Training EU MDR 2017/745 – December 11th – Green Belt Certification Program for EU MDR : https://school.easymedicaldevice.com/course/gb27
Medtech Conf
- Your Medtech Conferences – Register all your Events, Training, Conferences: https://medtechconf.com/
USA
- FDA withdrawal – not anymore member of the GHWP: https://www.fda.gov/media/174142/download
- Discontinuation in the USA – Notifying FDA of a permanent discontinuation: https://www.fda.gov/media/155245/download
- Webinar on Companion Diagnostics – Oncology Drug Products used with IVD tests: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program-12122023
Canada
- Medical Device Establishment Licenses annual review – You should receive your Christmas Package: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2024.html
Saudi Arabia
- Webinar: Clinical Trials of Medical Device Requirements – Click on the link in December 12th, 2023: https://www.sfda.gov.sa/en/workshop/93098
South Africa
- Guideline on Q&A for Licensing of Medical Device Establishment – Learn how to start this activity: https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf
Brazil
- Argentina & Brazil signed a Mutual Recognition Agreement – For certificates for Medical Devices: https://www.argentina.gob.ar/noticias/anmat-y-anvisa-firmaron-el-primer-acuerdo-de-reconocimiento-mutuo-en-certificados-para
SmartEye
- eQMS for Medical Device companies – Get your Demo now: https://smart-eye.io
Podcast Nostalgia
- How to CE certify a calculator, risk score software as Medical Device? Cesare Magri: https://podcast.easymedicaldevice.com/258-2/
- How to find a predicate Device for your 510k submission? Beat Keller: https://podcast.easymedicaldevice.com/259-2/
- What is the situation regarding Digitalization in the Medtech industry? MedXD https://podcast.easymedicaldevice.com/260-2/
Easy Medical Device support – info@easymedicaldevice.com
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
The post Medical Device News: December 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
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