Medical Device News – january 2024 Regulatory Update
Medical Device made Easy Podcast
English - January 10, 2024 00:00 - 45.8 MB - ★★★★★ - 17 ratingsCareers Business Education Courses medical device regulation medtech industry regulatory affairs iso mdr 2017/745 Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
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 […]
The post Medical Device News – january 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
Medboard
Who is Medboard
Medboard: https://www.medboard.com/
EU
EU Reference laboratories EURL
EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713
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 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf
MDCG 2019-07 rev 1 on PRRC
MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf
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
Medical Device without Medical Intended Purpose: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf
Emergency use of non-conform device
Exemption to Medical Device non-conforming: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw617_00_003d_mb-ausnahmebewilligung-mep.pdf.download.pdf/BW617_00_003e_MB%20Derogation%20MEP.pdf
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
Notified Body Situation; https://health.ec.europa.eu/system/files/2023-12/notifiedbodies_overview_en.pdf
Training:
EU MDR training
Green Belt training
28th edition January 22nd until 28th https://school.easymedicaldevice.com/course/gb28/
29th edition February 19th until 23rd https://school.easymedicaldevice.com/course/gb29/
30th edition March 25th until 29th https://school.easymedicaldevice.com/course/gb30/
Medical Device e-Training
eTraining
Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
ROW
Mexico:
Guide for obtaining the Health Registry of Medical Devices – https://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/
Brazil:
Brazil is calling Innovative Medical Devices
Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/dispositivos-medicos-inovadores-anvisa-prorroga-prazo-de-participacao-em-projeto-piloto
Hong-Kong:
Hong-Kong Guidances
Artificial Intelligence Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR008.pdf
Software Medical Devices and Cybersecurity: https://www.mdd.gov.hk/filemanager/common/mdacs/TR007.pdf
Guidance note for Listing Class II/III/IV General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
Guidance note for Listing Class B, C, D In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf
Classification of In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf
USA:
USA Export documents transition to digital
Transition to Electronic Export Documents – Letter to Industry: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry
India:
India New platform to register
National Single Window System (NSWS) Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTA=
Australia:
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
Australia on Custom-Made and Patient Match
How to submit a custom-made medical device / patient-matched medical device notification: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
Malaysia
Malaysia is telling rules on Borderline products
Harmonised borderline products in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-borderline-products-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWJvcmRlcmxpbmUtcHJvZHVjdHMtaW4tYXNlYW4tc2Vjb25kLWVkaXRpb24tMi1wZGYiLCJpYXQiOjE3MDIzNDcxOTksImV4cCI6MTcwMjQzMzU5OX0.4cNrbv3GpbG2KjL6uQxcxm3KeBGLsxZy77JqQKiIXUc
Malaysia is telling rules for classification of products
List of harmonized classification of Medical Devices in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-classification-of-medical-device-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWNsYXNzaWZpY2F0aW9uLW9mLW1lZGljYWwtZGV2aWNlLWluLWFzZWFuLXNlY29uZC1lZGl0aW9uLTItcGRmIiwiaWF0IjoxNzAyMzQ3MTk5LCJleHAiOjE3MDI0MzM1OTl9.WbMya1V8vykQ88aQyqpraMR4G7rZ_QA36hN_DOEeqso
Podcast Nostalgia
Podcast Nostalgia
Episode 262 – What is usability: https://podcast.easymedicaldevice.com/262-2/
Episode 263 – Why you should invest in your Regulatory Team: https://podcast.easymedicaldevice.com/263-2/
Episode 264 – Life of a QA RA Podcaster https://podcast.easymedicaldevice.com/264-2/
Episode 265 – Heatmap: https://podcast.easymedicaldevice.com/265-2/
The post Medical Device News – january 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir