Currently, only CE-marked medical devices complying with European medical device regulations (MDR/IVDR) can be placed on Swiss market. As other countries Switzerland relies on import of medical devices to treat Swiss population.
In fact, with endorsement of stricter MDR/IVDR regulations, aiming more quality and safety for patients, the trading of the medical devices was apparently affected. According to a report on the availability of Medical Devices published on 14 July 2022 by MedTech Europe, the implementation of MDR challenged the EU medical device market. A negative effect for EU member states and Switzerland is shortage of available medical devices. This turns out to be even more problematic for manufactures of medical devices resulting in reducing their portfolio up to 15%. Besides financial and resources issues to properly implement the MDR/IVDR, the manufacturer pointed out limited availability of Notified bodies. These difficulties led to endorsement of new Regulation (EU) 2023/607 on 15 March 2023. This regulation aims to mitigate the risk of shortages of safe medical devices and extend the transition period for manufacturers and notified bodies in compliance with the applicable legislation under certain conditions.
For this apparent issue of ensuring enough medical devices for Swiss patients, the Swiss Federal Council put forward a motion to guarantee a sustainable and sufficient supply of safe medical products. On 28 November 2022 Parliament passed Motion «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population», submitted by Damian Müller, member of the Council of States. This proposal aims a unilateral recognition of certificates from regulatory systems outside the EU, such as carried out in the USA by the U.S. Food & Drug Administration (FDA).
Thereby, the Federal Council commissioned the FOPH (Federal Office of Public Health FOPH - BAG) to perform the clarification with Swissmedic for possible adaptation of the national law. In particular, Switzerland will define comparably strict requirements for approval medical devices without the CE mark.
Sources:
Comments