The ball is in the politicians’ court: maintaining direct access to the EU single market
Due to the coronavirus pandemic, the European Parliament decided mid-April to postpone the MDR date of application by one year. The delay also means that Swiss medical devices are able to be placed on the market within the EU single market up until 26 May 2021 as before – i.e. without the need to fulfil non-member country requirements. A survey conducted by Swiss Medtech shows how crucial this extra year is for getting the industry ready for non-member country requirements. In May 2020, the original MDR date of application, 28 percent of Swiss manufacturers would not have been ready. Together they would have suffered a sales loss of an estimated 0.8 billion Swiss francs in the first year. According to the survey, this share will drop to nine percent or 0.4 billion Swiss francs by May 2021. The survey also shows that the administrative effort for fulfilling the non-member country requirements will cost the industry an initial 114 million Swiss francs and an annually recurring cost of 75 million Swiss francs.
The association recommends that these companies use this extra time to prepare themselves for the eventuality that the Mutual Recognition Agreement (MRA) will still not be updated in a year’s time. «However, if the industry wants to ensure that goods are exported into the EU smoothly and independent of the EU-Swiss political situation, it must be prepared for this eventuality,» says Peter Biedermann, Managing Director of Swiss Medtech.
Swiss Medtech is strongly adhering to the political demand that the MRA will be rapidly updated – irrespective of the progress made with the Institutional Framework Agreement. «The medical technology industry is a healthy and innovative industry with great economic importance. Switzerland is one of the world’s most attractive locations for medical technology. The ongoing legal uncertainty majorly jeopardises investment attractiveness. We expect the Federal Council with all its options to be committed to maintaining direct access to the EU single market,» states Biedermann.
Swiss Medtech represents more than 600 members in its role as industry association for Swiss medical technology. With 63,000 employees and a contribution of 16.4% to the positive trade balance, medical technology is an economically significant sector in Switzerland. Swiss Medtech advocates for conditions that enable the medtech industry to perform at peak capacity and provide first-class medical care.