According to the latest Swiss MedTech survey, Switzerland is expecting a shortage of up to 26% of imported medical devices in the second half of 2022. The imminent supply issues will translate into a loss of about 1.5 billion CHF, inevitably affecting the Swiss medical sector.
On 16 November 2021, the association expressed its concerns during a meeting with the Directorate of the Federal Office of Public Health (FOPH) and the Directorate of the supervisory authority Swissmedic. However, rather than responding to Swiss MedTech’s demand to remove import barriers, the Competent Authorities took the following position:
- No legal uncertainty for the medical sector can be identified;
- The Mutual Recognition Agreement (MRA) between Switzerland and the European Union is no longer applicable;
- Medical devices approved under MDD need to be relabeled;
- Existing import barriers should not be removed;
- To place medical devices on the Swiss market, manufacturers are required to appoint a Swiss authorized representative (CH-REP) and add both CH-REP and the importer on the label.
According to the opinion of Swiss MedTech’s Legal Experts, the MRA is still applicable as no official termination or suspension was ever notified. Their view seems to meet the Federal Council’s position. Additionally, the Obligations for Economic Operators CH (Pflichten Wirtschaftsakteure CH) information sheet, which also explains labelling obligations, does not constitute a valid legal basis. Nevertheless, Swiss MedTech advises manufacturers to independently decide if and how to incorporate the Federal Council’s official position and the other legal opinions when planning their business strategy (Swiss MedTech, 2021).
If Swiss MedTech won’t reach an understanding with the Competent Authorities in the next few weeks, the Board promises to advocate for new measures at the beginning of January 2022.vvv
We strongly advise manufacturers to follow the opinion of the Competent Authorities explained in the bullet points above.
Giorgia de Stefano
Regulatory Affairs Department
28.12.2021
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References:
- Swiss MedTech. (2021). Information for the Industry from Swiss Medtech. Retrieved on 28/12/2021 from https://www.swiss-medtech.ch/en/news/information-industry-swiss-medtech-10
- Swiss MedTech. (2021). Information for the Industry from Swiss Medtech – Update on the import of old-law medical devices: Missing legal basis for the labelling of MDD products. Retrieved on 28/12/2021 from https://www.swiss-medtech.ch/en/news/information-industry-swiss-medtech-11