When is a medical device "placed on the market" in Switzerland?

Dr. Stefan Menzl, PhD "What inspires me everyday is how applied medical technology makes a positive change to patients lives. Qserve offers the unique combination of a global reach, high level of expertise and staff with field experience and former positions at manufacturers, Notified Bodies, US FDA or China CFDA."
The term “placing on the market” is interpreted in different ways (see below), which leads to great uncertainty. Depending on which interpretation is used, negative consequences for patient care in Switzerland are possible.

Swiss Medtech has had a legal opinion drawn up on the interpretation of the term "placing on the market". This concludes that there is a certain amount of room for interpretation, but agrees with that of Medtech Europe: "The view of Medtech Europe, which is based on an interpretation that conforms with European law, must therefore be agreed, according to which a medical device is deemed to have been "placed on the market" if it was imported into Switzerland by a Swiss distributor (who thereby becomes an importer).»

Swiss Medtech demands that the scope for interpretation allowed by the definition of “placing on the market” be interpreted by the
authorities in favor of patient care in Switzerland. Swiss Medtech points out to their members that the Swiss Autority, Swissmedic  "will examine and take the necessary measures as usual in specific individual cases while maintaining proportionality".

Different interpretations create confusion

Swissmedic describes in its information sheet "Duties for economic operators in Switzerland", that  "placing on the market in Switzerland" as making a product available on the Swiss market for the first time (e.g. through transfer or leasing between economic operators or from a Swiss economic operator to a healthcare facility/to the consumer). It remains unclear whether the "transfer between economic operators" includes the transaction between foreign manufacturers and Swiss importers.

Blue Guide: The European Blue Guide states: "If a manufacturer or importer makes a product available to a dealer or end-user for the first time, this is always legally referred to as "placing on the market". It remains unclear whether the initial transfer of a medical device by a manufacturer to the EU importer always counts as “placing on the market” or not.

Medtech Europe describes "placing on the EU market" as the process by which the product leaves the manufacturing phase and enters the distribution phase in the EU. It is therefore clear that the first transfer of a medical device by a manufacturer to the EU importer already counts as “placing on the market” if the latter introduces the products with the intention of selling them in the EU.

The interpretation has far-reaching consequences

Which interpretation is used has far-reaching consequences for the supply of medical devices in Switzerland. Swiss retailers manage their warehouses in such a way that they are always able to deliver. However, it will not be clear until the end of the transition periods in accordance with Art. 104a MepV whether the foreign manufacturer has named a CH-REP for all its products or not. If he does not have this, the goods are in stock depending on the interpretation of the term "placing on the market".
  1. compliant because already placed on the market or
  2.  non-compliant and thus become worthless.

Source: Swiss Medtech


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