Medical Device News February 2026 Regulatory Update

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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…

The skinny

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