Devices without an intended medical purpose include, among others, products that change a person's appearance, such as contact lenses without vision correction, products for fat reduction and dermal fillers, and laser devices to improve one's completion. The product groups are listed in Annex 1 of the Medical Devices Ordinance (“MedDO”).
In terms of function and risk profile, devices without an intended medical purpose are comparable to medical devices. Therefore, devices without an intended medical purpose must now be treated as medical devices as regards market access (conformity assessment with a designated body (DB)) and post-market surveillance.
In order for manufacturers of such devices without an intended medical purpose to demonstrate the intended performance, their products must meet the requirements of the MedDO and the common specifications. The latter stipulate new requirements for risk management and the clinical assessment and how the devices must be inspected in order to demonstrate their safety and performance.
This is meant to ensure greater protection for consumers and users in future.
Last modification 26.10.2023