The Federal Council has decided to amend the Medical Devices Ordinance (MedDO) to improve the safety of products without an intended medical purpose (media release dated 29 September 2023). Switzerland has adapted its MedDO for these products in line with the EU requirements (Implementing Regulation 2023/1194) taking into account the new transitional periods. The required amendments to the MedDO have been approved and will enter into force on 1 November 2023.
New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices
Amendments of the EU-MDR 2017/745 regarding transitional periods for certificates, and of the EU-MDR and EU-IVDR 2017/746 regarding the elimination of deadlines for putting into service and placing on the market, were published in the EU on 20 March 2023. Swissmedic published a communication on enforcement in March 2023. The provisions have now been transposed into the ordinances in Switzerland and approved by the Federal Council.
The Implementing Regulations (2022/2346/47) tighten the requirements for product groups without an intended medical purpose that are comparable with medical devices in terms of their function and risk profile. These products fall under the scope of the MedDO (Art. 1 para. 1 let. a). They are mainly used in cosmetics, cosmetic surgery, bodyforming and in isolated instances also in interventional psychiatry and by opticians.
Annex 1 MedDO lists the product groups without an intended medical purpose that will in future have to meet the common specifications set out in Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022. This concerns in particular the application of risk management according to the general safety and performance requirements set out in Annex I EU-MDR and the clinical assessment.
Reclassification of certain active products
The reclassification of active products without an intended medical purpose in Implementing Regulation (EU) 2022/2347 is taken into account in Art. 15 and Annex 5a MedDO.
Extension of transitional periods
In line with the extended transitional periods for medical devices approved on 20 March 2023, the Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 also granted additional time for the transition from current legislation to medical devices legislation for product groups without an intended medical purpose listed in Annex XVI to the EU-MDR. This has also been taken into account in the revision of the MedDO.
At the time the changes enter into force on 1 November 2023, Swissmedic will update its website in this regard and publish implementation guides. At the same time, the common specification will be defined in the Federal Gazette, whereby the requirements of MedDO will also apply to product groups without an intended medical purpose.
Implementing Regulation (EU) 2022/2346 including Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Commission Implementing Regulation (EU) 2022/2346 regarding the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to the EU-MDR: EUR-Lex - 32022R2346 - EN and EUR-Lex - 32023R1194 - EN
Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose EUR-Lex - 32022R2347 - EN