On September 29, 2023, the Swiss Federal Council amended the Medical Devices Ordinance to improve the safety of products not intended for medical use, aligning it with the requirements of the European Union. The opportunity was also taken to align the Ordinances on Medical Devices (ODmed) and In Vitro Diagnostic Medical Devices (ODIV) with Regulation (EU) 2023/607. The revisions to the ODmed and ODIV, approved last September, will enter into force on November 1, 2023.
Concerning products without a medical purpose, which are mainly used in cosmetics, cosmetic surgery, body shaping and optics, it is stipulated that, as with MDR (EU) 2017/745, they will be regulated by the ODmed as their functions and risk profiles are similar to those of Medical Devices.
There are several parts of the measure that now regulate these devices. Article 15 and Annex 5 regulate the classification of products not intended for medical use, while Annex 1 lists products not intended for medical use whose application of the common specifications set out in Implementing Regulation (EU) 2022/2346 and Implementing Regulation (EU) 2022/2347 of the European Commission will also be mandatory for Switzerland.
As regards the extension of the transitional deadlines for Medical Devices and IVDs adopted in the EU on March 20, the Swiss Federal Council transposed the Implementing Regulation (EU) 2023/1194 by granting the extension until December 31, 2027 or 2028 depending on the risk class of the device also to products without a medical purpose.
>> If you want to market Medical Devices and IVDs or products without a medical purpose in Switzerland, Thema can assist you with Strategic-Regulatory Consulting for classification definition and check the conformity of product and system documentation (including labelling), acting as Swiss Authorised Representative (CH REP) and providing support in the registration of products with Swissmedic.
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