Switzerland: Swissmedic and in-house medical devices

When is AI software a medical device in Switzerland?

Switzerland adopts the terms of the EU Medical Device Regulation (EU MDR). According to Swissmedic’s information sheet on medical device software (version 3.0, April 2026), software is a medical device if it is used for a medical purpose for the benefit of an individual and does more than store, archive, communicate, compress without loss or run a simple search. What counts is the intended purpose set by the manufacturer, regardless of whether the software runs in the cloud, on a server or on a phone.

For AI in hospitals, this means: an app that drafts letters or searches guidelines is generally not a medical device. An app that suggests diagnoses or treatments from a patient’s findings is one. In detail: Own AI apps and the medical device trap.

What does Art. 9 MedDO allow?

Health institutions may manufacture, modify and use devices themselves on a non-industrial scale if no equivalent device is commercially available. These in-house devices must meet the general safety and performance requirements of Annex I EU MDR, but not the further requirements of the Medical Devices Ordinance (MedDO, in German MepV), provided the conditions of Art. 5(5) EU MDR are met. In-house devices are deemed to be put into service, not placed on the market. They need no conformity assessment, no certificate from a designated body and no UDI, and they may not bear a conformity marking.

Under Art. 4(1)(k) MedDO, a health institution is an organisation whose primary purpose is the care or treatment of patients or the promotion of public health. These are mainly hospitals, but also laboratories.

Which conditions apply in detail?

Condition	What Swissmedic understands by it
Quality management	Controlled processes for manufacture, use and traceability; MDCG 2023-1 serves as orientation
No equivalent device	“Market” means the Swiss market; comparison for example by operating principle, group of operators, target patient group
Public declaration	The devices meet Annex I EU MDR; deviations with justification (template in MDCG 2023-1, Annex A)
Documentation	Manufacture, design, performance data and intended purpose
Clinical experience	Evaluate it and make corrections
Risk management	Across the whole life cycle, from development to decommissioning

For software, Swissmedic also requires minimum requirements for hardware, IT networks and IT security, including protection against unauthorised access (Art. 74 MedDO, Annex I EU MDR).

How does notification to Swissmedic work?

The EU MDR leaves notification duties to the member states; Switzerland requires them: health institutions notify their in-house devices before putting them into service (Art. 18 MedDO). Swissmedic’s notification form asks for, among other things, the name, intended purpose and risk class. In addition:

• a signed declaration under Art. 5(5)(e) EU MDR,
• a confirmation of a suitable quality management system,
• if available, a copy of the instructions for use.

Where does the exemption end?

In its guidance on in-house medical devices (May 2025), Swissmedic names, among others, these cases that are not in-house devices:

• Supply to another legally independent institution, even within a hospital group, if the hospitals are legally, economically and organisationally independent. The device then needs a conformity marking, and the hospital passing it on becomes the manufacturer.
• Patients of another institution on whom the device is used.
• Industrial scale, meaning more than the calculated own requirement.
• Purely economic reasons without a clinical need.
• Software adjustments within the intended use, such as parameterisation that the manufacturer expressly provides for: they do not make a device an in-house device. If, on the other hand, a hospital programs scripts that the manufacturer does not provide for, a new device is created.

Components, including purchased software, do not have to be created in the hospital. The institution does, however, take on full responsibility for design and use.

What applies to an AI platform on which the hospital builds apps?

The platform is a component. Whether a medical device is created depends on the intended purpose of each app, not on the platform. A clear separation helps in daily work: apps for letters, summaries and research on one side; apps related to diagnosis or treatment only after review by quality management, with notification to Swissmedic and a declaration under Art. 5(5)(e) EU MDR.

How does this work with basebox?

basebox is not a medical device but a platform for general tasks such as drafting letters or searching guidelines. If your hospital uses it to build an application with a medical intended purpose, your hospital is its manufacturer. For your documentation, basebox provides the information of a supplier: model register with version and licence, software bill of materials and ISO 27001 certificate. Every answer shows its sources with the quoted passage; the audit log records who used which app. Basics: Is an AI platform a medical device?

Not legal advice: The MedDO and the current guidance and information sheets from Swissmedic are authoritative. Swiss AI regulation is in preparation. Clarify individual cases with Swissmedic or a medical device law specialist. Research as of: 11 October 2026.