Medical Device News February 2026 Regulatory Update

SPONSOR

• Medboard: https://www.medboard.com/

EUROPE

 New Harmonization Standards –  Implementing Decision 2026/193: 

• https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193
  • Neurosurgical implants
  • EN ISO 14155:2020 on clinical investigations
  • EN ISO 18562 series on Biocompatibility for Breathing gas pathways

• Germany: Transition from DMIDS to EUDAMED – March 19, 2026:
  • https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770
    • EUDAMED mandatory by May 28th, 2026

• High-Level Conference on Medical Devices – March 16th, 2026 – Brussels:
  • https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_en

The conference will feature three breakout sessions focusing on:

• Enhanced predictability for conformity assessments: combining certainty with flexibility
• Clinical evidence at EU level to support the regulatory framework: the key role of Expert Panels
• Breakthrough technologies for better care: turning guidance into reality

• Team-NB: Letter on Cybersecurity – MDR and IVDR proposal draft version:
  • https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdf

Switzerland

• Swissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:
  • https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf
• Swissdamed Webinar – May 28th, 2026:
  • https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.html

UK

• UK to exempt Health Institution – Not a priority for now
  • https://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devices

Training

• Team-NB: Training on MDR technical Documentation – For manufacturers on April 19th, 2026:
  • https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/

EasyIFU

• Create eIFU and Labels easily – Compliance to EU MDR/IVDR:
  • Https://easyifu.com

RoW

North America

• FDA: General Wellness devices – Guidance by the FDA:
  • https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices
• FDA: Cybersecurity in Medical Devices – QMS and Pre-market submission:
  • https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket

APAC

• Malaysia: Electronic Certificates issued by MDA – For FSC, Manufacturing Certificates and Export Certificates
  • https://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysia
• India: Import of IVD – Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3D

Africa:

• Egypt: Database for Product Registration -Online Electronic Service: 

https://eservicesdata.edaegypt.gov.eg/MedicalDevices

Middle East

• Saudi Arabia: SFDA inspection of QMS requirements – Process that would be followed:
  • https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdf

Podcast

• Episode 372 – How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/
• Episode 373 – QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/
• Episode 374 – Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/

Services

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• Authorized Representative: [email protected]

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