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What is a Medical Device?

Overview​

In Switzerland, whether a product is a medical device is determined by its intended purpose — not its materials or appearance. The definition sits in MedDO Art. 3 para. 1 (SR 812.213), mirroring EU MDR 2017/745 Art. 2(1). If a product meets this definition, it generally must be registered with Swissmedic before being placed on the Swiss market.

Under MedDO Art. 3 para. 1, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by its manufacturer to be used, alone or in combination, for humans for one or more of these purposes:

  • Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation of or compensation for injury or disability
  • Investigation, replacement, or modification of anatomy or a physiological process
  • Providing information by in vitro examination of specimens from the human body
  • Control or support of conception
  • Disinfection or sterilisation of another medical device

A medical device achieves its purpose principally by physical, mechanical, or chemical means — not by pharmacological, immunological, or metabolic action (those are medicinal products).

Why Intended Purpose Matters​

The intended purpose determines both whether something is a medical device and which class it falls into. Swissmedic assesses intended purpose from what the manufacturer states or implies through labelling, IFUs, promotional materials, and technical documentation. The same product may or may not be a medical device depending solely on the claims made about it.

Software as a Medical Device​

Software is explicitly included in the MedDO definition. Standalone software intended for a medical purpose is regulated as a medical device in its own right. Qualification guidance MDCG 2019-11 applies in Switzerland — see Software as a Medical Device.

IVD Devices​

IVDs — products used for the in vitro examination of human specimens — are regulated under the separate IVDO (SR 812.219). See MedDO vs IVDO.

Official Sources​

Disclaimer

Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.