Swissmedic requires individual notifications for in-house IVD and in-house MD in Switzerland as of 1 January 2027; switch to individual reporting.

Swissmedic: Individual Notifications for In-House IVD and In-House MD as of 1 January 2027

Swissmedic: Individual Notifications for In-House IVD and In-House MD as of 1 January 2027

From 1 January 2027, products used and manufactured in health institutions (in-house IVD and in-house MD) may no longer be reported via collective notifications. From this date onwards, notifications under art. 10 Ordinance on In Vitro Diagnostic Medical Devices (IvDO) and art. 18 Medical Devices Ordinance (MedDO) must be submitted exclusively on an individual basis.

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Source: https://www.walderwyss.com/de/news/2026-04-17_swissmedic-individual-notifications-for-in-house-ivd-and-in-house-md-as-of-1-january-2027
sdDatePublished: 2026-04-30T12:08:00Z
Topics: healthcare policy, regulatory authority, legal service
Locations: Switzerland