Last month, the National Council adopted the motion “Authorisation of medical devices in compliance with non-European regulatory systems”. After the entry into force of the MDR in the EU, this is a first important step for the security of supply for patients in Switzerland as well as the innovative capability of the Swiss medical technology industry. The motion now goes to the Council of States.

Only medical devices that meet the requirements of the EU’s medical devices regulation are authorised in Switzerland today. In other words: Products that bear a CE mark. Due to the breakdown of the negotiations on the Framework Agreement, the EU declared the Mutual Recognition Agreements (MRA) for medical devices to be invalid. This means that a medical device approved in Switzerland is no longer automatically approved in the EU.

Reducing dependency

Switzerland is therefore dependent on the EU’s certification bodies. Certification in accordance with the European Medical Device Regulation (MDR), which is often described as “over-regulated”, is a complex process and the certification bodies are overloaded. The motion by National Councillor Albert Rösti therefore calls for Switzerland to acknowledge

certification bodies outside of Europe, such as the US Food and Drug Administration (FDA), which also makes high demands.

Strengthening innovative power

The recognition of further approval systems enables Swiss medical technology companies to choose the approval system best suited to their product. Especially in the area of digital medical devices, the American approval system is more advanced than the European one. Many innovative Swiss medical device manufacturers already have their products approved by the FDA. This results in pioneering inventions being available in the USA but not in their country of origin, Switzerland.

Ensuring supply

According to the MDR, not just new products but also existing products must be recertified. This leads to a high administrative effort both for the manufacturers and for the test centres. Therefore, as well as considerable delays, a reduced supply of medical devices is also to be expected, because many companies cannot afford the costly (re)certification. As a consequence, the security of supply for patients can no longer be guaranteed. The recognition of non-European approval systems means that it would still be possible to guarantee the supply of medical technology products in Switzerland.

The Federal Council asks for patience so that a way can be found for constructive cooperation with Europe. However, as a manufacturer of precision parts used in innovative medical technology companies in Switzerland, we hope that the Council of States will follow the example of the National Council and adopt the motion. The motion encourages progress and secures the supply of medical technology in Switzerland.