Medical Device News November 2025 Regulatory Update

MedBoard

EU

• Joint clinical assessment procedure –  EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086
• Team-NB position paper on Companion diagnostics – Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf
• MDR and IVDR put at risk transplantation – Donor Screening and SoHo preparation: https://www.edqm.eu/documents/52006/162284/PA-PH-TO%20%2824%29%2018%20%E2%80%93%20Risks%20to%20safety%20and%20quality%20in%20donor%20screening%20and%20SoHO%20preparations%20due%20to%20poor%20implementation%20of%20the%20MDR%20and%20IVDR%20%E2%80%93%20CD-P-TO%20Position%20paper%20%E2%80%93%20October%202025.pdf/51d5efb2-4611-13ad-76a0-b5710b371248
  • Dedicated proportionate regulatory pathway for Niche fields
  • Article 5(5.g) requirements to the highest risk categories (Health institutions to create documentation for the products)
  • Update of MDCG guidance on In-house devices to better reflect the operational reality.
  • Off-label use and RUO are not falling on Article 5.5 so grey zone.

• Team-NB proposal for MDR & IVDR – 5 topics on the agenda:  https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/
  • Early dialogue: Use of this to talk to Notified Bodies
  • Article 61.10 & WET: Update for more clarity. Narrow the scope.
  • Digitalisation: Machine readable documents, AI to support simulations to reduce Animal testing.
  • Coding for MD and IVD
  • Designation and recertification: For Notified Bodies
  • Breakthrough: Coordinated pathway with challenge to generate Clinical Data.
• Notified Bodies Count – S New comers for MDR and IVDR:
  • SGS Fimko oy (IVDR 19): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1016921
  • ICIM S.P.A. (MDR 51) : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43747&filter=notificationStatusId:1
  • Notice (MDR): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1020121
• Standards
  • New Harmonized Standards – Clothing and sterilisers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502078
  • Biocompatibility
  • ISO TS 23485: https://www.linkedin.com/posts/melazzouzi_iso13485-iso-medicaldevice-activity-7393773266689228801-d7LM?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI
• UK Reliance with US FDA – Harmonization is ongoing: https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai

Service

• eIFU with free access -Test it and let us know : https://Easyifu.com
• eQMS for a structured Quality Management System – Get your demo: https://eqms-smarteye.com/

Magazine

• eMagazine . EMD Mag Free- Are Notified Bodies still the right model: https://easymedicaldevice.com/emd-mag/

ROW

• US FDA: Pre-RFD -:Combination product: https://www.fda.gov/media/189466/download
• US FDA: QMSR guidelines -: How to create a QMS: https://www.fda.gov/media/189345/download

PODCAST

• Podcast review –  What happened in October 2025
  • Episode 357 – Highlights from La Rentrée du DM 2025: https://podcast.easymedicaldevice.com/357-2/
  • Episode 358 – Clinical Evidence under EU MDR – Why so many dossier fail (And how to fix it): https://podcast.easymedicaldevice.com/358-2/
  • Episode 359 – Real World Evidence – How to use it right for FDA and EU: https://podcast.easymedicaldevice.com/359-2/
  • Episode 360: US Government Shutdown – What FDA can still be doing? Rob Packard: https://podcast.easymedicaldevice.com/360-2/
  • Episode 361 – Automatisation of your QA RA Job with AI – Hatem Rabeh:  https://podcast.easymedicaldevice.com/361-2/

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

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