When it comes to medical devices, Switzerland cannot rely without exception on the unsafe and long-lasting European introduction of MDR. The domestic demand for the next few years requires the additional acceptance of products from other similarly safely regulated regions.

With the motion by Damian Müller, member of the Swiss Council of States, the Federal Council will also have to advocate the appropriate supply of medical devices in Switzerland. The approach of the Swiss administrations presented so far in the consultation of 15 May 2019 is obvious and correct, but it is by no means sufficient for the national medical device supply for the next years.

Since 1996, Switzerland has relied on regulation of medical devices in line with that of the EU. This has worked very well so far and with free trade between the EU and Switzerland there have hardly been any product shortages since then.

This is now changing fundamentally with the current European regulatory revision MDR (Medical Devices Regulation). The MDR, which came into force in 2017, has so far only been known for hardly practicable specifications. Even after three years, testing bodies, expert committees, additional legal acts, and guidelines are still not available or at most only in rudimentary form. Their establishment is by no means guaranteed under the given conditions. It is therefore not very controversial that the currently blatantly visible weaknesses can only be remedied by further adjustments to EU law. As a result, final introduction will continue to drag on for years. From today’s point of view, a fully functional MDR can hardly be expected before 2030, which means that a secure supply of products will suffer greatly.

As a non-EU member state, Switzerland must, on the one hand, maintain and expand its valuable trade relations with the EU. To this end, it must undoubtedly continue to recognise CE-marked products. In addition, however, it must also be able to orient itself towards products that originate from other regions that are regulated with comparable certainty. These may include products that have been authorised for marketing in the USA, Canada, Japan, and Australia. Especially with the experience we have gained from the current pandemic, it would be incomprehensible if the obvious need for diversification of marketable products were to remain impossible. In addition to the patients affected, this would also benefit Swiss trade.

Submitted text

The Federal Council is instructed to adapt the legislation in such a way that medical devices from non-European regulatory systems can also be authorised for marketing in Switzerland.

Justification

Due to its size and resources, Switzerland is not able to supply itself with all the medical devices it needs, nor to test / assess all the medical devices it requires itself and authorise them for placing on the market in Switzerland. It is also dependent on foreign countries for both the testing / assessment and procurement of medical devices for national supply.

To date, Switzerland only accepts medical devices in accordance with the European Union (EU) approval system, namely CE or MD marked products, for national supply. This is against the background that the EU is Switzerland’s most important trading partner.

On 26 May 2017, the EU brought into force Regulation (EU) 2017/745 on medical devices (Regulation on Medical Devices, MDR). In view of the COVID-19 pandemic, the EU has postponed the original date of application (DoA) of the MDR by one year to 26 May 2021. The problems with the implementation of the MDR were already manifold and known before the outbreak of the corona virus pandemic. Experts consider the new regulation to be too ambitious and assume that it will only be operational throughout Europe after several years and various adjustments. Consequently, there is no guarantee that the Swiss population can be supplied with sufficient quality-tested medical devices in the coming years.

In view of this uncertainty, it is irresponsible to rely exclusively on CE-marked medical devices for national supply. It is appropriate and far-sighted to extend the scope of action for the procurement of medical products to include medical devices of non-European regulatory systems. The legal prerequisites for this must now be created so that investment safety can also be established for the industrial and trading partners concerned.

Author: Peter Studer (Senior Advisor)