Medical Device News – November 2023 Regulatory Update

EU:

• UDI for contact lenses  Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197
• EUDAMED Roadmap It is a DRAFT: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf

• MDCG 2023-4 guidance – Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf
• Fees and charges payable to EMA: Expert Panel will cost you money : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_14057_2023_INIT
• Notified Bodies : Finland and Turkey
  • Sertio Oy (Finland) IVDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1001622
  • Notice Belgelendirme (1st Turkish Notified Body) MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=82870fd17389fc19149f103e8121acdc82fea1af&group=NOTIFICATION
  • Team-NB call for action to Manufacturers to apply: https://www.team-nb.org/wp-content/uploads/2023/10/Team-NB-PressRelease-Capacity-NotifiedBodies-during-transition-IVDR-MDR-October2023.pdf

Training for you

Increase your knowledge in QA RA :

• Vigilance Reporting in EU: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
• Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
• Green Belt training: December 11th until December 15th: LINK

Spain:

• Implementation of the HTA : EU Health Technology Assessment Regulations: https://www.aemps.gob.es/la-aemps/de-la-teoria-a-la-practica-implementacion-del-reglamento-de-evaluacion-de-tecnologias-sanitarias-de-la-ue/
• Regulation 2021/2282 on health technology assessment: https://health.ec.europa.eu/publications/regulation-eu-20212282-health-technology-assessment_en

Switzerland:

• Products without an intended medical purpose : Same as EU MDR: 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
• Obligation Economic Operators –: Update due to extension  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016e_MB_Obligations_Economic_Operators_CH.pdf
• General procedure for foreign governmental inspections – Inform Swissmedic before governments audit a manufacturer  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/i-308/i-308_aa_02-A01e_general_procedure_for_foreign_governmental_inspections_switzerland.pdf.download.pdf/I-308.AA.02-A01e_Merkblatt_General_procedure_foreign_govern_insp_CH_related_therapeutic_prod.pdf

MedTech Conf

Map of conferences available

• Conferences Map: https://medtechconf.com/
• Medica Dusseldorf November 13 -15 : https://medtechconf.com/event/medica-2023/
• TEAM-PRRC Strasbourg November 16 – 17: https://medtechconf.com/event/team-prrc-annual-summit-2023/

Turkey:

• Product not considered as a Medical Device – List of products available: https://titck.gov.tr/duyuru/tibbi-cihaz-yonetmelikleri-kapsaminda-degerlendirilmeyen-urunler-30102023120556

eQMS SmartEye:

• SmartEye is your eQMS – Ask for your DEMO : https://smart-eye.io/

USA:

• eStar is your new 510k : Since October 1st, 2023: https://www.fda.gov/media/152429/download

Australia:

• Webinar on UDI for Australia – November 21st, 2023 11.30 AEDT: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-udi-webinar-19-australian-udi-project-update-and-discussing-considerations-and-real-world-benefits-adopting-udi-healthcare

Podcast Nostalgia : You remember

• What are some pitfalls to avoid during Software Design? Weronika Michaluk: https://podcast.easymedicaldevice.com/253-2/
• Affrisummit 2023 Part 1 Morad Ajan, Rana Chalhoub, Dr. Mona Al Moussali: https://podcast.easymedicaldevice.com/254-2/
• Afrisummit 2023 Part 2 Nora El-Hariri and Mohamed Mahdy Ghonim: https://podcast.easymedicaldevice.com/255-2/
• Validate your iPhone, Samsung Galaxy, Huawei for your Software Erik Vollebregt: https://podcast.easymedicaldevice.com/256-2/