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
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
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
