Swiss hospitals are complaining about a lack of materials, such as catheters or implants. The reason for this is the stricter conditions for the approval of such products in the EU. The requirements were changed after the scandal surrounding defective breast implants.
The European Medical Devices Regulation has therefore been in force since 2017. All companies that want to sell medical devices in the EU must first approve these products in accordance with the provisions of this regulation.
However, the approval process is taking longer than planned. For over a year, a motion has been calling for products from the USA, for example, to be used as an alternative to products approved in the EU.
BAG knows of no major bottlenecks
However, implementation is stalling and this is affecting everyday life in Swiss hospitals, reports SRF in the program «10vor10».
The Federal Office of Public Health (FOPH) wants to examine how it could approve medical devices from non-EU countries without endangering patient safety. However, it is unclear when this will happen. The FOPH has not identified any major supply bottlenecks.
Extended for in vitro diagnostics
However, the FOPH is also aware that the slow pace of EU approval could become a problem for Swiss hospitals. It has now informed the Federal Council that it is extending the transition periods, at least for so-called in-vitro diagnostics.
This means that blood, secretion or tissue tests can be sold under certain conditions even if they do not yet meet the new requirements. The aim is to minimize the risk of supply shortages, the BAG writes in a statement. The transition period will now apply until the end of the year – as in the EU.
New Swissdamed database from 2026
From 2026, manufacturers of medical devices and in vitro diagnostics will have to register all products in a central database. Medinside reported here about the new Swissdamed database.
