When is a medical device considered «placed on the market» in Switzerland?
Swiss Medtech has commissioned a legal opinion on the interpretation of the term «placing on the market». It concludes that there is some room for interpretation, but agrees with that of Medtech Europe: «The view of Medtech Europe, which is based on an interpretation in conformity with European law, is thus to be endorsed, according to which a medical device that is marketable on the Union market or the Swiss market is deemed to have been «placed on the market» if it has been imported into Switzerland by a Swiss distributor (who thereby becomes an importer).»Link to legal opinion (in German)
Swiss Medtech demands that the scope for interpretation allowed by the definition of «placing on the market» be interpreted by the authorities in favour of patient care in Switzerland. We would like to point out to our members that Swissmedic – according to the authority's response – «will examine and take the necessary measures in the specific individual case as usual, while maintaining proportionality».
Differing interpretations create confusion
- In its information sheet «Obligations Economic Operators CH» Swissmedic describes «placing on the market in Switzerland» as first making available of a device on the Swiss market (e.g. via a transfer or supply between economic operators or from a Swiss economic operator to a healthcare facility / the consumer). It remains unclear whether «transfer between economic operators» includes the transaction between the foreign manufacturer and the Swiss importer.
- Blue Guide: The European Blue Guide states: «When a manufacturer or an importer supplies a product to a distributor or an end-user for the first time, the operation is always labelled in legal terms as "placing on the market». It remains unclear whether the first transfer of a medical device by a manufacturer to the EU importer is always considered as «placing on the market» or not.
- Medtech Europe describes «placing on the market in the EU» as the act when the product is released from the manufacturing phase and enters the distribution phase in the EU. This makes it clear that the first transfer of a medical device by a manufacturer to the EU importer is already considered as «placing on the market» if the importer imports the devices with the intention to distribute them in the EU.
The interpretation has far-reaching consequences
Which interpretation is applied has far-reaching consequences for the supply of medical products in Switzerland. Swiss distributors manage their stocks in such a way that they are always able to deliver. However, it will not be clear until the end of the transitional periods in accordance with art. 104a MedDO whether the foreign manufacturer has designated a CH-REP for all its products or not. If he has not, depending on the interpretation of the term «placing on the market», the product in stock is
a) compliant, since it has already been placed on the market, or
b) non-conforming and therefore worthless.
Swiss Medtech represents around 700 members in its role as industry association for Swiss medical technology. With 63,000 employees and a contribution of 16.4% to the positive trade balance, medical technology is an economically significant sector in Switzerland. Swiss Medtech advocates for conditions that enable the medtech industry to perform at peak capacity and provide first-class medical care.