Netherlands?locations_select=6596&page=1 Latest Articles
Life Sciences and Healthcare
Revised EU medtech regulations proposal sharpens software and cybersecurity rules for digital health
Down‑classification, established software concepts and cyber-incident reporting could reshape digital medtech compliance
New
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15/01/2026
Read time
7m
Life Sciences and Healthcare
Proposed EU medtech laws seek more predictable and efficient notified body oversight
Structured dialogue, streamlined sampling, extended audits and SME‑friendly fees to reshape device conformity assessment
13/01/2026
Read time
8m
Digital Regulation
Simplification for AI Medical Devices?
How the European Commission’s proposal on amending the MDR and IVDR adds to the simplification efforts by the Digital Omnibus packages for AI-enabled medical devices and IV diagnostic devicesThis article was authored by Julia Kaufmann, Dr. Florian Eisenmenger and Marina Fröhlich.
New
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12/01/2026
Read time
1m
Life Sciences and Healthcare
EU revised device rules rebalance compliance towards simplification and proportionality
Commission proposal would streamline MDR and IVDR duties with flexible evidence, timeless certificates and tailored risk rules
09/01/2026
Read time
9m
