Medical Device News – january 2024 Regulatory Update

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
  • Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-12-06_en

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:
• Mexico registration rules

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/

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