Product conformity under the Medical Devices Ordinance

Classification is subject to Annex VIII EU-MDR, taking account of the implementing acts listed in Annex 5a MedDO, which define specific rules of classification for the (active) product groups 4 to 6 in Annex 1 MedDO.

Furthermore, the “Borderline Manual” must be observed, which places facial and other dermal and mucous membrane fillers under the highest risk class of III.

The classification also determines the conformity assessment procedure to be conducted so that a compliant device can be made available under Art. 23 MedDO.

• Determine whether your device falls under one of the six product groups listed in Annex 1 MedDO^[1] and whether you are thus affected by the new requirements.
• Familiarise yourself with the legal requirements under the MedDO, the EU-MDR and the common specifications for product groups without an intended medical purpose. See also the Explanatory report[not available in English] of the FOPH for background information on the MedDO.
• Make a note of 1 May 2024. The devices must have been marketed in Switzerland by this date in order to benefit from the transitional rules .
• Based on the intended purpose, determine the risk class (Art. 15 MedDO) for your devices under Annex VIII EU-MDR, taking account of the exceptions for the active product groups under Annex 5a MedDO.
• Prepare technical documentation in accordance with Annexes II/III EU-MDR to provide evidence of conformity with the general safety and performance requirements in Annex I and the common specifications of Commission Implementing Regulation 2022/2346.
• Perform a clinical assessment and, if needed, a clinical study or “post-market clinical follow-up study” to secure sufficient evidence of the safety and performance of your devices in accordance with Annex XIV EU-MDR.
• Submit an application for a conformity assessment procedure in accordance with Annex VII section 4.3 EU-MDR with a notified body and perform the assessment. A list of the notified bodies can be found in “NANDO”: EUROPA - European Commission - Growth - Regulatory policy - NANDO.
• After successful completion of the conformity assessment procedure, you can affix the conformity marking and the identification number according to Art. 13 MedDO to your devices and issue the declaration of conformity according to Art. 29 MedDO.
• You must register with Swissmedic as an economic operator – see Registering economic operators (CHRN) (swissmedic.ch).
• You must establish a post-market surveillance system and report any events or serious incidents relating to your devices. Reporting incidents & FSCAs (vigilance) (swissmedic.ch).

^[1] _{Art. 1 para. 2 MedDO}

* _{The information and legal provisions presented are reproduced in a simplified form for better understanding. Ultimately, the provisions of the laws and regulations apply.}