On September 29, 2023, Swissmedica released 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.
The required amendments to the MedDO have been approved and will enter into force on November 1, 2023.
On March 20, 2023, the EU introduced amendments to EU-MDR 2017/745 regarding transitional certificate periods, and to EU-MDR and EU-IVDR 2017/746 regarding the removal of deadlines for putting into service and market placement. Swissmedic also issued an enforcement communication in March 2023 to ensure equivalence with EU Medical Devices Regulation. These provisions have been incorporated into Swiss ordinances and approved by the Federal Council.
Additionally, Implementing Regulations 2022/2346/47 now imposes stricter requirements on product groups without a medical purpose but similar in function and risk profile to medical devices. These products, used mainly in cosmetics, cosmetic surgery, bodyforming, and occasionally in interventional psychiatry and by opticians, now fall under MedDO jurisdiction (Art. 1 para. 1 let. a). Annex 1 of MedDO lists these product groups, which must adhere to common specifications outlined in Commission Implementing Regulation (EU) 2022/2346 from December 1, 2022. This specifically involves implementing risk management and clinical assessment in accordance with the general safety and performance requirements in Annex I of EU-MDR.
Find the FULL resource and more information on reclassification, extension, and implementation here.
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