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/