   
  
G/TBT/N/CHE/258/Add.1  
 
18 February 2022  
(22-1584) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  18 February 2022 , is being circulated at the request of the 
delegation of Switzerland . 
 
_______________  
 
 
Title: Draft ordinance on in -vitro diagnostics  
 
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[  ] Notified measure withdrawn or revoked - date:  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:   
[X] Content or scope of notified measure changed  and text available from1: The final version 
of the new Swiss In vitro Diagnostic Medical Devices Ordinance (IvDO) will be available 
on the following website: 
https://www.fedlex.admin.ch/en/home?news_period=last_day&news_pageNb=1&news
_order=desc&news_itemsPerPage=10   
New deadline for comments (if applicable):  30 days from notification  
[  ] Interpretive guidance issued and text available from1:  
[  ] Other:  
 
Description:  Content of changed notified measures are summarized as follows:  
Adjustments due to the lack of update of Chapter 4 of the Switzerland -EU MRA  
The Mutual Recognition Agreement on conformity assessment between Switzerland and the 
European Union (Switzerland -EU MRA) guarantees the market access in the sector of medical devices 
(Annex 1, Chapter 4 of the MRA) between Switzerland and the EU. The MRA is based on the 
equivalence of the legislation between Switzerland and the EU. The draft of the new Swiss In vitr o 
Diagnostic Medical Devices Ordinance (IvDO) is therefore equivalent to the new EU In vitro 
Diagnostic Medical Devices Regulation (IVDR). The IvDO draft was notified to the Committee on 
Technical Barriers to Trade (TBT Committee) of the WTO on the 21st of June 2021 parallel to the 
public consultation procedure. The IvDO is foreseen to enter into force on the 26th of May 2022.  
 
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/C HE/258/Add.1  
 
- 2 - 
 
  In order for the mutual recognition elements between Switzerland and the EU under the MRA to 
apply to the new in vitro legislation, Chapter 4 on medical devices of the Agreement should be 
updated to reflect the upcoming entry into force of the new Swiss IvDO and of the EU IVDR on 
26 May 2022. This said, due to political reasons, Chapter 4 of the MRA could not be updated on 26 
May 2021,  when the new Swiss Medical Ordinance (MedDO) entered into force simultaneously with 
the EU MDR. As a result, the access to the central European database EUDAMED is denied to the 
Swiss authorities and there is a lack of cooperation with the EU in market su rveillance. Without an 
update of the MRA on 26 May 2022, transitional measures similar to those implemented and 
communicated for the Swiss MedDO to mitigate these and other negative effects resulting from this 
situation are foreseen in the new Swiss IvDO. These include deadlines for the appointment of an 
authorized representative in Switzerland.  
The main adjustments notified under the Addendum are the following:  
• Recognition by Switzerland of certificates issued by a notified body designated under EU 
law and established in an EU or EEA state;  
• Transitional periods for the appointment of an authorized representative in Switzerland for 
manufacturers based in the EU or EEA and for manufacturers with an authorized 
representative in the EU, depending on the prod uct classification;  
• Additional flexibilities for labeling requirements for the Swiss authorized representative and 
the importer within the scope of tolerance in enforcement of the MedDO will apply equally 
for the IvDO;  
• Due to the denial of access to EUDAME D, the following main adjustments are foreseen:  
o References to EUDAMED are deleted and replaced where necessary by notifications 
to Swissmedic;  
o Swiss economic operators must register the required information according to 
Annex VI EU -IVDR with Swissmedic wi thin a defined period of time;  
o Manufacturers report serious incidents and safety corrective measures in the field 
to Swissmedic.  
Progressive roll -out of the IvDO  
There is a serious shortage of notified body capacity, making it impossible for manufacturers to 
conduct the legally required conformity assessment procedures in time. Without legislative actions, 
there would be a risk of significant disruption in the supply of various essential in vitro diagnostic 
medical devices on the market. This would affect the diagnosis of patients and their access to 
relevant health care. Therefore, Switzerland has decided to introduce a progressive roll -out of the 
Swiss IvDO similar to that of the EU.  
__________  
 
 