Swissmedic Publishes Updated Online Help for the Medical Device Publication Service
Swissmedic has released version 1.2 of its guidance document “Online help for the MD publication service”, valid from 09 February 2026. This document supports manufacturers and stakeholders in navigating the Swissmedic online platform that publishes Field Safety Corrective Actions (FSCAs) and associated Field Safety Notices (FSNs).
What is the MD Publication Service?
Swissmedic maintains an online list of FSCAs concerning medical devices placed on the market in Switzerland and Liechtenstein. Every reported corrective action is published together with the corresponding FSN, ensuring transparency for professional users, distributors, and manufacturers.
Each FSCA is managed as an individual case and assigned a unique Swissmedic reference number in the format:
Vk_YYYYMMDD_xx
Key Information Displayed for Each Publication
The guidance explains the main data fields shown on the platform, including:
Publication date
Manufacturer name
Trade name and device identifiers (model, lot, serial number, software version)
Device type classification (MD or IVD)
Linked FSNs available in multiple languages
Swissmedic reference number
For manufacturers, this highlights the importance of ensuring that FSNs are complete, accurate, and clearly traceable through identifiers.
Publication Status: Updates and Additional Languages
Swissmedic distinguishes between:
First publication of a case
Publication with additional language versions
Updates to previously published cases
Updates including new translations
Importantly, the first publication date never changes, even when updates are issued.
Updates may include content-related corrections, expanded recall scope, or new follow-up information.
Search and Export Functions: Practical Tools for Manufacturers
The publication service includes advanced search options, allowing users to filter FSCAs by:
Free text
Last 7 days, last month, or last year
User-defined date ranges
Showing only updates
Swissmedic - Guidance document …
Swissmedic also provides search operators (*, +, |, -, “ ”) to refine results.
For manufacturers monitoring market safety trends, the platform also allows exporting search results into a CSV/Excel format for internal tracking and analysis.
Language Availability and Transparency
Swissmedic clarifies that device descriptions are published only in English because they rely on internationally used nomenclatures (e.g., GMDN, EMDN).
FSNs may not always appear in all Swiss national languages if the device is not marketed in all regions, or if translations are submitted later.
Additionally, older versions of FSNs remain accessible online to preserve transparency and ensure that historical safety information remains available.
Why This Matters for Medical Device Manufacturers
For manufacturers placing devices on the Swiss or Liechtenstein markets, this updated guidance reinforces:
The importance of timely FSCA reporting
Maintaining clear FSN documentation and traceability
Understanding how corrective actions are published and updated
Using Swissmedic’s platform for proactive vigilance and compliance monitoring
Swissmedic typically publishes cases within two weeks of receiving at least one FSN.
Read the full document below.
