Progressive Rollout dates
Remarkably, not only the Ordinance has become applicable as of May 26, 2022, the same date of application as Regulation (EU) IVDR 2017/746, but has also implemented the same EU IVDR progressive rollout dates in Switzerland. According to Art. 82 IvDO, in fact:
Provided that from May 26, 2022, the following products continue to comply with the previous law and that there are no significant changes in the design and intended purpose of the product in question, they can continue to be placed on the market or put into operation up to the following dates:
- Products with a valid certificate under Article 81 ( devices with IVDD CE Certificates issued by a Notified Body): until May 26, 2025 or until Certificates expires, whichever comes sooner [can be made available or put into service until May 26, 2026]
Products for which the participation of a notified body was not required under the previous law as part of the conformity assessment procedure, but for which such is required under this Ordinance, and which have a declaration of conformity issued before May 26, 2022, under the previous law:
- Class D products: until May 26, 2025 [can be made available or put into service until May 26, 2026]
- Class C products: until May 26, 2026 [can be made available or put into service until May 26, 2027]
- Class B products: until May 26, 2027 [can be made available or put into service until May 26, 2028]
- Class A devices placed on the market in a sterile condition: until May 26, 2027 [can be made available or put into service until May 26, 2028]
In a nutshell:
|Classification under the new legislation:||Can comply with old legislation util:||Can Be Made Available Until:|
|IVDD NB CE Certificates||26 May 2025||26 May 2025|
|Class A, non-sterile||26 May 2022||26 May 2025|
|Class A, sterile||26 May 2027||26 May 2028|
|Class B||26 May 2027||26 May 2028|
|Class C||26 May 2026||26 May 2027|
|Class D||26 May 2025||26 May 2026|
Although the IvDO is mostly aligned with the EU IVD Regulation, among the notable differences of the new Swiss Ordinance, there is the requirement to appoint a Swiss Authorized Representative for non-Swiss IVD manufacturers, including European manufacturers, who will no longer enjoy single market access to Switzerland.
The deadlines to appoint a Switzerland Authorized Representative (CH-REP) under the IvDO for manufacturers already on the market are:
- Class D → December 31, 2022
- Class C & B →March 31, 2023
- Class A → July 31, 2023
Manufacturers entering the Swiss market after May 26, 2022, must appoint a Swiss Authorized Representative immediately.
Timeline for Registration of the economic operators
Lastly, an additional target date that is certainly worth mentioning is the last day to obtain a unique Swiss registration number (CHRN) for Swiss Manufacturers, Swiss Authorized Representatives and Swiss Importers:
- IVDR devices placed on the market for the first time after May 26, 2022, → within three months after being placed on the market
- IVDR devices that have been placed on the market prior to May 26, 2022, → by November 26, 2022
- IVDD devices placed on the market for the first time after May 26, 2022, → within three months after being placed on the market
- IVDD devices that have been placed on the market prior to May, 26 2022, → no obligation to register
Non-Swiss manufacturers and CH-distributor are not required to obtain a CHRN.
If you are looking for more background on the status of the Mutual Recognition Agreement between the EU and Switzerland, please read here.
Do you want to know all the implications of the new Swiss Ordinance? Are you a non-Swiss based manufacturer? Contact us today to direct you towards Obelis CH, your future Authorised Representative for the Swiss market!
Obelis CH Regulatory Affairs Department
Interested in selling your medical devices in Switzerland? Obelis can act as your Swiss Authorized Representative and turn your Swiss journey into a success story! Contact us today.
- Swissmedic. (2022). IVDR News. Retrieved on 30/05/2022 from https://www.swiss-medtech.ch/en/news/ivdr-portal
- Swissmedic. (2022). Latest news: Nuova regolamentazione dei dispositivi medico-diagnostici in vitro dal 26 maggio 2022. Retrieved on 30/05/2022 from https://www.swissmedic.ch/swissmedic/it/home/news/mitteilungen/neue-regulierung-in-vitro-diagnostika.html
- Fedlex. (2022). Ordinanza relativa ai dispositivi medico-diagnostici in vitro (ODIV) del 4 maggio 2022 (Stato 26 maggio 2022) – RU 2022 291. Retrieved on 30/05/2022 from https://fedlex.data.admin.ch/eli/cc/2022/291
- Swissmedic. (2022). Information sheet on obligations for authorised representatives, importers and distributors. Retrieved on 30/05/2022 from https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016e_MB_Obligations_Economic_Operators_CH.pdf