TBT BSN | Notification

Notification Detail :: G/TBT/N/CHE/237/Add.1

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

(1) Projet de révision totale de l'Ordonnance sur les dispositifs médicaux (ODim, RS 812.213) (Complete draft revision of the Medical Device Ordinance (ODim, RS 812.213)), 50 pages, available in French, German and Italian; (2) Projet de nouvelle Ordonnance sur les essais cliniques de dispositifs médicaux (Oclin-Dim) (Draft new Ordinance on clinical trials for medical devices (Oclin-Dim)), 29 pages, available in French, German and Italian.

Objective

Protection of human health or safety (TBT); Harmonization (TBT)

Product Covered

Medical devices, except in vitro diagnostic medical devices

Document Notification

Link to ePing

HSCODE

ICSCODE

11.040 - Medical equipment; 11.040 - Medical equipment

Keywords

Human health

Specific Regions

Description

The new regulations concerning medical devices (Medical Devices Regulation, MDR) and in vitro diagnostic medical devices (In vitro Diagnostic Medical Devices Regulation, IVDR) entered into force on 26 May 2017. In order to improve the safety and quality of medical devices, Switzerland adapted its legislation on medical devices in line with developments in European law. The new legislations in Switzerland are applicable since 26 May 2021 for medical devices (MedDO) and 26 May 2022 in vitro diagnostic medical devices (IvDO) like in the EU.On December 1, 2022, the European Commission adopted two implementing regulations 2022/2346 and 2022/2347 establishing new requirements for product groups without an intended medical purpose (Annex XVI MDR). These same product groups are already listed in Annex 1 of the MedDO and were notified to the WTO (G/TBT/N/CHE/237). Once Swissmedic has designated the common specifications, the MedDO will also apply to product groups without an intended medical purpose listed in Annex 1. Additionally, on March 15, 2023, the EU adopted the Regulation (EU) 2023/607 extending the transition period from the old to the new regulations under certain conditions. Switzerland will align with the EU by extending its transition periods. The changes in the European regulations concerning medical devices will be transposed into the Swiss legislation in order to maintain the equivalence with the European regulations.

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/CHE/237/Add.1

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