Medical Device News - january 2024 Regulatory Update

• Medboard: www.medboard.com/
EU
EU Reference laboratories EURL
• EU Reference laboratories for IVD products: eur-lex.europa.eu/legal-conte...
o Article : health.ec.europa.eu/latest-up...
Letter to EU Parliament
Letter sent to the European Parliament - Cybersecurity: eur-lex.europa.eu/legal-conte...
MDCG 2023-7 on Clinical Investigation
• MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: health.ec.europa.eu/document/...
MDCG 2019-07 rev 1 on PRRC
• MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: health.ec.europa.eu/system/fi...
MDCG 2021-27 on Importer and Distributor
MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: health.ec.europa.eu/system/fi...
MDCG 2023-5 on Annex XVI class
MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: health.ec.europa.eu/system/fi...
MDCG 2023-6 on Annex XVI Equivalency
MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: health.ec.europa.eu/system/fi...
Companion Diagnostics CDx
EMA Q&A on Companion Diagnostics CDx: bit.ly/48Iz9PN
Switzerland
Guidance on Devices with no medical purpose
• Medical Device without Medical Intended Purpose: www.swissmedic.ch/dam/swissme...
Emergency use of non-conform device
• Exemption to Medical Device non-conforming: bit.ly/48OwCU3
Notified Bodies:
New Notified Body under EU MDR
43rd NB MDR - CESKY METROLOGICKY INSTITUT - Czech Republic: bit.ly/48hXYSR
Notified Body Situation
Training:
EU MDR training
• Green Belt training
o 28th edition January 22nd until 28th school.easymedicaldevice.com/...
o 29th edition February 19th until 23rd school.easymedicaldevice.com/...
o 30th edition March 25th until 29th school.easymedicaldevice.com/...
Medical Device e-Training
• eTraining
o Vigilance Reporting: school.easymedicaldevice.com/...
o Audit Readiness: school.easymedicaldevice.com/...
ROW
• Mexico:
• Mexico registration rules
Guide for obtaining the Health Registry of Medical Devices - app.medboard.com/your-medboar...
• Brazil:
• Brazil is calling Innovative Medical Devices
o Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: bit.ly/4aSCY6L
• Hong-Kong:
• Hong-Kong Guidances
o Artificial Intelligence Medical Devices: www.mdd.gov.hk/filemanager/co...
o Software Medical Devices and Cybersecurity: www.mdd.gov.hk/filemanager/co...
o Guidance note for Listing Class II/III/IV General Medical Devices: www.mdd.gov.hk/filemanager/co...
o Guidance note for Listing Class B, C, D In-Vitro Diagnostic Medical Devices: www.mdd.gov.hk/filemanager/co...
o Classification of In-Vitro Diagnostic Medical Devices: www.mdd.gov.hk/filemanager/co...
• USA:
• USA Export documents transition to digital
o Transition to Electronic Export Documents - Letter to Industry: bit.ly/3vvJksM
• India:
• India New platform to register
o National Single Window System (NSWS) Portal: bit.ly/3vA6QVi
• Australia:
Australia Boundary and Combination products
guide on boundary and combination products bit.ly/3RPUCQ2
• Australia on Custom-Made and Patient Match
o How to submit a custom-made medical device / patient-matched medical device notification: bit.ly/4aQaeeX
•Malaysia
• Malaysia is telling rules on Borderline products
o Harmonised borderline products in ASEAN: bit.ly/3vpEjSh
• Malaysia is telling rules for classification of products
o List of harmonized classification of Medical Devices in ASEAN:
Podcast Nostalgia
Episode 262 - What is usability: podcast.easymedicaldevice.com...
• Episode 263 - Why you should invest in your Regulatory Team: podcast.easymedicaldevice.com...
• Episode 264 - Life of a QA RA Podcaster podcast.easymedicaldevice.com...
• Episode 265 - Heatmap: podcast.easymedicaldevice.com...