The current revision of medical device legislation came into force six months ago, but numerous aspects of the reform are still unclear and are causing uncertainty in the industry. A central question in the regulation of medical devices is, which products are covered by the regulations. This article therefore provides an overview of the scope of the revised medical device law - with a focus on the adapted definition of the term "medical device". It thus follows on from our previous articles on the subject.
I. What qualifies as a medical device?
A medical device may be an instrument, an appliance, software, an apparatus, implants, reagents, materials, or other objects which have a medical purpose, or which are advertised as having a medical purpose. Medical devices are used in connection with the treatment or prevention of diseases; classical medical devices are also devices for the detection and monitoring of diseases. Thus, adhesive plasters, clinical thermometers, crutches, and wheelchairs, but also pacemakers or the COVID app are considered medical devices.
This is to be distinguished from medicinal products, which are also regulated in the Therapeutic Products Act (TPA), but which are regulated in more detail and are subject to more restrictive specifications. "Therapeutic product" is the generic term; it includes both medicinal products and medical devices. Whereas "medicinal products" have a pharmacological, immunological, or metabolic effect (medical effect), "medical devices" are used in a mechanical, physical or physico-chemical way (medical use).
II. Medical purpose no longer a mandatory requirement
The above-mentioned products with a medical purpose were already classified as medical devices under the old law. However, individual product groups that do not have a medical purpose have now been added. This extension of the scope was made in accordance with the new legal situation in the EU.
The Swiss legislator has listed the product groups now covered in Annex 1 of the revised Medical Devices Ordinance (MedDO). This list covers, for example, contact lenses without correction or lasers for removing tattoos. The products listed have similar or the same risks as the classical medical devices. Therefore, in order to improve the quality of the products and the safety of patients, they are now also regulated by medical device law.
III. Software as a medical device
Among other things, the revision is intended to make it possible to determine the qualification of software as a medical device more clearly. The revision also introduced stricter requirements for medical device software ("MDSW").
Whether software qualifies as a medical device can be difficult to assess under certain circumstances. However, due to the efforts to align Swiss law with EU law, the principles of EU law can be used as an aid to interpretation. One recommended aid is the document "Guidance on Qualification and Classification of Software" (MDCG 2019-11), which lists various notes and examples on the qualification of software as a medical device.
A MDSW must be intended for medical use on humans and independently fulfil at least one medical purpose. A distinction must be made between MDSWs and apps that offer mere guidance for fitness training or diets. A MDSW must also have a medical purpose for a single individual. This criterion excludes software with a pure function of collecting or structuring medical data from the scope of the MedDO. However, products for the prevention or promotion of conception are explicitly mentioned in the Medical Devices Ordinance. "Fertility apps" and "contraceptive apps" are therefore considered medical devices regardless of their medical purpose.