Information for the Industry from Swiss Medtech

Talks with authorities concerning imports

On 16 November, Swiss Medtech representatives met in person with the Directorate of the Federal Office of Public Health (FOPH) and the Directorate of the supervisory authority Swissmedic to further explain requests it had submitted (22 September, in writing) in connection with the Medical Devices Ordinance (MepV), as well as its grave concern about the imminent shortfalls in supply. 

We deeply regret not having more positive news to report. The authorities have communicated their position: as they see it, (a) there is no legal uncertainty for the medtech sector, (b) the EU has declared Article IV of the Medical Devices Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) to be no longer applicable" (Editorial: amended 29.12.2021), (c) legal basis does exist to require relabelling of medical devices approved under the old law (MDD products), and (d) there is no reason to remove existing import barriers as a precautionary measure to ensure availability of medical devices.

The FOPH and Swissmedic support the position that the appointment of a Swiss authorised representative (CH-REP), as well as the labelling with the CH-REP and importer, should remain prerequisite for placing imported medical devices on the market.

Problems with supply

Swiss Medtech’s latest survey indicates that supply issues are looming for the second half of 2022: responders estimated shortages of currently imported medical products of up to 26% – a corresponding value of 1.5 billion CHF. Swiss Medtech is very concerned that Swiss health authorities are not taking the necessary measures to prevent these looming supply problems. The association clearly expressed its incomprehension on 16 November – and subsequently also in writing. Ensuring medical device supply to the Swiss population is of overriding interest. From a public health perspective, it is essential that Swiss authorities work together with the industry and other health stakeholders in order to find proactive preventative solutions. The association will continue its awareness-raising campaign – with the authorities as well as the most important health stakeholders, politicians, and media.

From the Executive Board

The Board of Swiss Medtech is currently examining further measures to advocate for the interests of the sector, and to combat the impending issues with supply.