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Medical Device News – january 2024 Regulatory Update

 
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Manage episode 394372815 series 2591977
Contenu fourni par Monir El Azzouzi. Tout le contenu du podcast, y compris les épisodes, les graphiques et les descriptions de podcast, est téléchargé et fourni directement par Monir El Azzouzi ou son partenaire de plateforme de podcast. Si vous pensez que quelqu'un utilise votre œuvre protégée sans votre autorisation, vous pouvez suivre le processus décrit ici https://fr.player.fm/legal.
episode 266 Medical Device News – january 2024 Regulatory Update easy medical device monir el azzouzi

Medboard

Who is Medboard

EU

EU Reference laboratories EURL

Letter to EU Parliament

Letter sent to the European Parliament – Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INIT

MDCG 2023-7 on Clinical Investigation

MDCG 2019-07 rev 1 on PRRC

MDCG 2021-27 on Importer and Distributor

MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf

MDCG 2023-5 on Annex XVI class

MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf

MDCG 2023-6 on Annex XVI Equivalency

MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf

Companion Diagnostics CDx

EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf

Switzerland

Guidance on Devices with no medical purpose

Emergency use of non-conform device

Notified Bodies:

New Notified Body under EU MDR

43rd NB MDR – CESKY METROLOGICKY INSTITUT – Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true

Notified Body Situation

Training:

EU MDR training

Medical Device e-Training

ROW

Guide for obtaining the Health Registry of Medical Deviceshttps://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/

Australia Boundary and Combination products

guide on boundary and combination products https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf

Podcast Nostalgia

Podcast Nostalgia

podcast episode 266 Medical Device News – january 2024 Regulatory Update easy medical device monir el azzouzi

The post Medical Device News – january 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

  continue reading

317 episodes

Artwork
iconPartager
 
Manage episode 394372815 series 2591977
Contenu fourni par Monir El Azzouzi. Tout le contenu du podcast, y compris les épisodes, les graphiques et les descriptions de podcast, est téléchargé et fourni directement par Monir El Azzouzi ou son partenaire de plateforme de podcast. Si vous pensez que quelqu'un utilise votre œuvre protégée sans votre autorisation, vous pouvez suivre le processus décrit ici https://fr.player.fm/legal.
episode 266 Medical Device News – january 2024 Regulatory Update easy medical device monir el azzouzi

Medboard

Who is Medboard

EU

EU Reference laboratories EURL

Letter to EU Parliament

Letter sent to the European Parliament – Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INIT

MDCG 2023-7 on Clinical Investigation

MDCG 2019-07 rev 1 on PRRC

MDCG 2021-27 on Importer and Distributor

MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf

MDCG 2023-5 on Annex XVI class

MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf

MDCG 2023-6 on Annex XVI Equivalency

MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf

Companion Diagnostics CDx

EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf

Switzerland

Guidance on Devices with no medical purpose

Emergency use of non-conform device

Notified Bodies:

New Notified Body under EU MDR

43rd NB MDR – CESKY METROLOGICKY INSTITUT – Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true

Notified Body Situation

Training:

EU MDR training

Medical Device e-Training

ROW

Guide for obtaining the Health Registry of Medical Deviceshttps://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/

Australia Boundary and Combination products

guide on boundary and combination products https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf

Podcast Nostalgia

Podcast Nostalgia

podcast episode 266 Medical Device News – january 2024 Regulatory Update easy medical device monir el azzouzi

The post Medical Device News – january 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

  continue reading

317 episodes

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