Medical Device News – january 2024 Regulatory Update

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

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