Swiss Medtech survey: Medical technology industry does its homework
The ball is in the politicians' court: maintaining direct access to the EU single market
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Bern (ots)
The European Parliament's decision to postpone the Medical Devices Regulation (MDR) date of application by one year benefits the Swiss medical technology industry. A Swiss Medtech survey shows that the majority of the industry can achieve the transition to nonmember country requirements by May 2021. Swiss Medtech is strongly adhering to the political demand of maintain-ing 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 com-mitted to maintaining direct access to the EU single market," states Biedermann.
Further information
Presentation of Swiss Medtech survey results on the non-member country requirements (German only)
Contact:
Anita Holler
Head of Communication
+41 31 330 97 72
+41 76 527 35 54
anita.holler@swiss-medtech.ch