G/TBT/N/CHE/237/Add.1  
 
7 July 2023  
(23-4614) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  6 July 2023, is being circulated at the request of the delegation 
of Switzerland . 
 
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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 (Ocl in-Dim) (Draft new Ordinance on clinical trials for medical devices (Oclin -
Dim)), 29 pages, available in French, German and Italian.  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[ ] Notified measure enters into force - date:  
[ ] Text of final measure available from1:  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:  
[ ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[ ] Interpretive guidance issued and text available from1:  
[X] Other:  
1. Transposition into Swiss legislation of the Regulation (EU) 2023/607 of the European 
Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 
and (EU) 2017/746 regarding the transitional provisions for certain medical devices and 
in vitro diagnostic medical devices  
2. Transposition into Swiss legislation of the Commission Implementing Regulation (EU) 
2022/2346 of 1 December 2022 laying down common s pecifications rules for the 
application of Regulation (EU) 2017/745, including the Commission implementing 
Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 
2022/2346  
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/CHE/237/Add.1  
 
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  3. Transposition into Swiss legislation of the Commission I mplementing Regulation (EU) 
2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 
2017/745 December 2022  
 
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 produ ct 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.  
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