Swissmedic Publishes Updated Information Sheet on Medical Device Software (Version 3.0)
Swissmedic has released version 3.0 of its Information Sheet on Medical Device Software (MDSW), with validity from 21 April 2026.
The document provides an overview of the regulatory framework, qualification, classification, and requirements applicable to medical device software under Swiss legislation aligned with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Scope and regulatory framework
The information sheet applies to manufacturers, developers, and economic operators involved in the distribution of medical device software.
It references:
EU MDR (Regulation (EU) 2017/745)
EU IVDR (Regulation (EU) 2017/746)
Swiss Medical Devices Ordinance (MedDO)
Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO)
Relevant MDCG guidance documents and technical standards
Definition of medical device software
Software is included in the definition of a medical device under both MedDO and IvDO.
Medical device software may:
Be part of a physical medical device, or
Constitute a standalone medical device
A medical device is defined as a product intended by the manufacturer for medical purposes such as diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.
Qualification as medical device software
Software qualifies as a medical device if:
It is intended for a medical purpose for the benefit of an individual; and
Its functionality goes beyond storage, archiving, communication, simple search, or lossless compression of data
The intended purpose, as defined by the manufacturer, is the determining factor for qualification.
The qualification is independent of:
The deployment environment (e.g. cloud, mobile device, computer)
Whether the software is standalone or part of a system
The intended user (professional or layperson)
The document also provides examples of software that are not considered medical devices, including:
Hospital resource planning software
Statistical analysis tools
Electronic patient records replacing paper-based systems
General, non-personalised medical information tools
Classification of medical device software
Medical device software is classified according to MDR/IVDR classification rules, taking into account intended purpose and associated risks.
Key principles include:
Software that drives or influences a medical device is classified in the same class as that device
Standalone software is classified independently
If multiple classification rules apply, the strictest rule determines the classification
The document notes that software may be classified in a higher class than the hardware with which it is used, depending on its functionality.
Regulatory requirements
Medical device software must comply with applicable regulatory requirements, including:
General safety and performance requirements (Annex I MDR/IVDR)
Technical documentation (Annex II and III MDR/IVDR)
Clinical evaluation or performance evaluation
Product identification, including UDI requirements
Labelling and instructions for use
The document specifies that software must be developed in accordance with the state of the art, including requirements related to:
Software lifecycle processes
Risk management
Verification and validation
IT security and cybersecurity considerations
Additional considerations
The information sheet also addresses:
Software developed and used within healthcare institutions
Software systems composed of multiple modules
Distance sales via information society services
Obligations of economic operators
Post-market surveillance and vigilance requirements
Update information
According to the change history, version 3.0 includes revisions related to regulatory requirements and obligations of economic operators, as well as a new layout.
Read the full document below.
