Medical Device News OCTOBER 2025 Regulatory Update

Medboard

Europe

• Too much Incomplete Tech File – Let’s explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf
• 2025/1920 on Master UDI-DI – Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920
• Borderline manual Update –  New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf
  • red blood cell additive solutions containing adenine
  • dual action cream with menthol and capsaicin
  • Lactose tablets for vaginal use
  • microabrasion dental stain removers
  • medical examination table covers
  • Mobile sterile air system
• EU asks your feedback on EU MDR and IVDR – Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en

Switzerland

• Swissdamed Technical Documentation – XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html
  • Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf

UK

• UK PMS guidance for Report – Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system
  • PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report

Magazine

• Issue 1: Sept/Oct 2025 – Next one will come November 2025: https://easymedicaldevice.com/emd-mag/

Events

• Medtech Conf events – Be listed on the MAP: https://medtechconf.com/events-map-2/

EasyIFU

• Free trial for eIFU with EASYIFU – Compliant EU 2025/1234: https://easyifu.com

ROW

• US FDA Computer System Assurance – SOP offered on the show notes: https://www.fda.gov/regultory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0
• https://mailchi.mp/easymedicaldevice/sop-computer-software-assurance
• Malaysia affiliate member of MDSAP – What does it change?:  https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member
• Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist
• Egypt guidance to import your devices – Medical Devices, Accessories, IVD:
  • All type of devices: https://edaegypt.gov.eg/media/lafopofx/1-regulatory-guideline-of-issuance-of-import-approvals-of-all-types-of-medical-devices_gd.pdf
  • Medical Equipment and Accessories: https://edaegypt.gov.eg/media/fltnd1qc/4-regulatory-guideline-of-issuing-import-approvals-for-medical-equipment-and-their-accessories_gd.pdf
  • IVD: https://edaegypt.gov.eg/media/e2rf4qg5/2-regulatory-guideline-of-the-procedures-and-rules-of-obtaining-import-approvals-for-iaboratory-and-diagnostic-equipment-gd.pdf

Podcast

• Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/
• Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/
• Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/

Easy Medical Device Service

• Support for Consulting (QA RA projects)
• Support for Authorized Representative and Market Access
• Integration to an eQMS

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device News OCTOBER 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir