When are disinfectants regulated as medical devices?

In December 2023, Swissmedic published an informative document on regulations of disinfectants in Switzerland. The legal requirements to sell disinfectants on the Swiss market differ based on the classification of the product. To classify a product, manufacturers must foremost define its intended use. Overall, we can distinguish three main categories given by their intended use:

• Medicinal products: products used for wound and skin disinfections to prevent/heal diseases or prepare patients to surgical intervention
• Medical devices: products intended for the disinfection of medical devices
• Biocidal product: products intended for hand and surface disinfection

In the case of medical devices, the legal frames are the Federal Act on Medicinal Products and Medical Devices and MedDO, the Medical Devices Ordinance.

MedDO requirements of disinfectants: conformity assessment paths

Generally, disinfectants used to disinfect medical devices are classified as class IIa under the MedDO. However, disinfectants of invasive devices and disinfectants of contact lenses are assigned to class IIb.

Like all upper-class devices, disinfectants must undergo a conformity assessment by a notified body and bear the CE or MD mark. Non-Swiss manufacturers must also appoint a Swiss authorised representative if they want to access the Swiss market, even if they are based in the EU.

The conformity assessment route varies based on the class of the device. For class IIa devices, the applicable conformity assessment route is the following:

• Technical Documentation for device category and QMS, or Product Quality Assurance or Product Verification, and Technical Documentation for device category
• Declaration of Conformity

Class IIb devices, instead, can be subject to the following conformity assessment route:

• Technical Documentation for every device and QMS,
  or Type Examination and Production Quality Assurance implementation or production verification
• Clinical evaluation consultation procedure
• Declaration of Conformity

The market surveillance authority in charge is Swissmedic, the Swiss Agency for Therapeutic Products.

Dual use products

Interestingly, according to the Swiss therapeutic products legislation, a product can be either a medicinal product or a medical device, depending on its main intended action. The dual use of a disinfectant as both a medicinal product and a medical device is not allowed. On the contrary, a product can be classified as both a biocide and a medical device as long as the product is subject to the applicable conformity assessment procedure for medical devices and the marketing authorisation as biocidal product by the FOPH. Such products can have labels and Instructions for Use that include the requirements of both ordinances.

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