If foreign manufacturers want to enter the Swiss market, there are certain measures they must take to be successful. In this blog article, we will highlight the most important steps that manufacturers should follow in order to offer their products in Switzerland.
If foreign manufacturers want to enter the Swiss market, there are certain measures they must take to be successful. In this blog article, we will highlight the key steps manufacturers should follow to offer their products in Switzerland.
Switzerland has revised the Medical Devices Ordinance (MedV) of 26.05.2021 and introduced additional requirements to reflect the lack of an update to the EU MDR. According to Article 51 of the revised MedV, manufacturers of medical devices located in EEA countries (except Liechtenstein) or represented by an EU authorized representative located in an EEA country must now appoint a Swiss authorized representative to sell their CE-marked products in Switzerland. The same applies to manufacturers of medical devices outside the EU market.
1. appointment of a Swiss proxy:
The appointment of a Swiss authorized representative is an important first step for foreign manufacturers. Manufacturers must carefully check whether the authorized representative has the necessary know-how and experience. Contractual clauses have to be negotiated and the mandate of the authorized representative in Switzerland has to be checked. This process requires time and patience.
A Swiss authorized representative is a person or company based in Switzerland that is appointed by a foreign manufacturer to perform certain tasks related to the manufacturer’s legal obligations under the Swiss Medical Devices Ordinance (MepV) and the In Vitro Diagnostics Ordinance (IvDV). The authorized representative assumes the role of representative of the foreign manufacturer before the Swiss authority Swissmedic.
By accepting the written order, the Swiss authorized representative becomes responsible for fulfilling certain tasks and obligations of the manufacturer. This includes, among other things, the formal and safety aspects of placing products on the Swiss market. The authorized representative is jointly and equally liable with the manufacturer for possible defects of the products.
It is important to note that, in accordance with the customs agreement with Liechtenstein, persons or companies based in Liechtenstein can also be considered Swiss authorized representatives, provided that the products are placed on the market in accordance with the MepV/IvDV.
The Swiss authorized representative thus plays a crucial role for foreign manufacturers wishing to enter the Swiss market. It supports them in meeting regulatory requirements and helps ensure product safety.
However, it should also be noted that Swissmedic defines “Swiss importers” in its leaflet Duties of economic operators CH “by action” and not “by designation”.
2. establish internal procedures in the quality management system:
To successfully serve the Swiss market, foreign manufacturers must adapt their internal procedures in the quality management system. This includes the establishment of communication processes, as well as the provision of the Technical Documentation in English or an official Swiss language within 7 days upon request by Swissmedic. A solid quality management system is essential to meet the requirements of the Swiss market.
3. arrange efficient logistics:
Smooth communication and efficient exchange of information and documents are crucial for success in the Swiss market. Manufacturers should ensure that they have appropriate logistics processes in place to ensure effective collaboration with their Swiss authorized representative. Well-designed logistics contribute to the fast and accurate processing of inquiries and orders.
4. careful verification of conformity:
The Swiss authorized representative will perform an initial verification of the conformity of the products. This review may result in the rejection of the mandate of the authorized representative, which obliges the manufacturer to seek a new Swiss authorized representative and go through the process again. Thorough preparation and adherence to the required standards are therefore essential to avoid such rejections.
5. adjust product labeling:
Product labeling must comply with Swiss requirements. Manufacturers should ensure that the Swiss authorized representative’s details appear correctly on the product label. This step may be necessary to comply with legal requirements in Switzerland. Accurate and precise product labeling is of great importance in gaining the trust of Swiss consumers.
Entering the Swiss market requires careful planning and implementation by foreign manufacturers. Appointing an experienced Swiss authorized representative, adapting internal procedures in the quality management system, setting up efficient logistics, carefully checking conformity and adapting product labeling are crucial steps on the road to success.
The introduction of the Swiss Authorized Representative as a new requirement contributes to the harmonization of regulations between the EU and Switzerland and ensures a high level of protection for patient safety and the quality of medical devices and in vitro diagnostics on the Swiss market.
By following all of the above steps, foreign manufacturers can successfully capture the Swiss market and maximize their growth potential.
Should you require further information or assistance in entering the Swiss market, please do not hesitate to contact us.
(Note: The information in this blog article is for informational purposes only and does not constitute legal advice…)