G/TBT/N/CHE/237  
28 May  2019 
(19-3704) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  French  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : SWITZERLAND  
If applicable, name of local government involved (Articles 3.2 and 7.2):   
2. Agency responsible : Office fédéral de la santé publique , OFSP (Federal Office of Public 
Health)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Secrétariat d'Etat à l'économie , SECO (State Secretariat for Economic Affairs)  
Holzikofenweg 36, 3003 Berne  
tbt@seco.admin.ch  
http://www.seco.admin.ch/  
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:   
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : Medical 
devices, except in vitro  diagnostic medical devices  
5. Title, number of pages and language(s) of the notified document:  
(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.  
6. Description of content : Following various events involving medical de vices, Europe has 
strengthened its regulations in this regard . Two regulations concerning conventional 
medical devices (Medical Devices Regulation, MDR[1]) and in vitro  diagnostic medical 
devices ( In vitro  diagnostic medical devices regulation, IVDR[2]), respectively, entered 
into force on 2 6 May 2 017. These texts will become fully applicable after various transition 
periods (up to three years for the MDR and up to five years for the IVDR) . The MDR will 
become fully applicable on 2 6 May 2 020. In order to im prove the safety and quality of 
medical devices, Switzerland has adapted its legislation on medical devices in line with 
developments in European law . In light of the partial revision of the Law on Therapeutic 
Products (LPTh) and the Law on Research involv ing Human Beings (LRH), adopted by the 
Swiss Parliament on 2 2 March 2 019, the present draft text provides for a full -scale reform 
of the right of enforcement, that is, a complete revision of the ODim and the establishment 
of a new Ordinance on clinical trials for medical devices (OClin -Dim). These Ordinances 
must enter into force at the same time as the legal amendments and at the moment when 
the EU law becomes applicable in the Member states (MDR : 26 May 2 020).  G/TBT/N/CHE/237  
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  The EU requirements on in vitro  diagnostics will be incorporated into Swiss law at a later 
date, by means of a separate ordinance (entry into force in May 2 022).  
The main amendments are as follows:  
• Manufacturers must prove, through clinical studies, the benefits and 
appropriateness of high -risk products, and assess their safety.  
• The approval and monitoring criteria for clinical trials and performance tests have 
been strengthened.  
• Each device must have a unique device identification (IUD) number to allow for 
their unequivocal identification and guarantee full traceability.  
• Various data must be recorded in the European Database on Medical Devices 
(EUDAMED) . Some of  these data must be made available to the public in an 
understandable form.  
• The requirements to be met by the competent authorities and conformity 
assessment bodies, and their responsibilities, are regulated in a clearer and 
stricter manner . Furthermore, t he new provisions address existing gaps.  
[1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 
2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 
and Regulation (EC) No 1223/2009 and repealin g Council Directives 90/385/EEC and 
93/42/EEC, Official Journal L 117 of 5 May 2 017, p. 1.  
[2] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 
2017 on in vitro  diagnostic medical devices and repealing Directive 98/79/EC an d 
Commission Decision 2010/227/EU, Official Journal L 117 of 5 May 2 017, p. 176.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Harmonization with European legislation (MDR), protection of patient and 
user health and  safety  
8. Relevant documents:  
• Projet d'Ordonnance sur les dispositifs médicaux (ODim)  
French , German , Italian  
• Projet d'Ordonnance sur les essais cliniques de dispositifs médicaux (OClin -Dim) 
French , German , Italian  
• Current Ordinance on medical devices:  French , German , Italian 
9. Proposed date of adoption : April 2 020 
Proposed date of entry into force : 26 May 2 020 
10. Final date for comments : 60 days from the date of notification.  G/TBT/N/CHE/237  
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
• Projet d'Ordonnance sur les dispositifs médicaux (ODim)  
French:  
https://www.admin.ch/ch/f/gg/pc/documents/3051/2019 -05-15_ODim_fr.pdf  
German:  
https://www.admin.ch/ch/d/gg/pc/documents/3051/2019 -05-15_MepV_de.pdf  
Italian:  
https: //www.admin.ch/ch/i/gg/pc/documents/3051/2019 -05-15_ODmed_it.pdf  
• Projet d'Ordonnance sur les essais cliniques de dispositifs médicaux (OClin -Dim) 
French:  
https://www .admin.ch/ch/f/gg/pc/documents/3051/2019 -05-15_OClin -Dim_fr.pdf  
German:  
https://www.admin.ch/ch/d/gg/pc/documents/3051/2019 -05-15_KlinV -Mep_de.pdf  
Italian:  
https://www.admin.ch/ch/i/gg/pc/documents/3051/2019 -05-15_OSRUm -Dmed_it.pdf