Swiss Medtech National Regulatory Conference

Over 400 people once again attended Swiss Medtech’s national industry event in Bern. The former MDR & IVDR Conference took place under the new title of National Regulatory Conference. The renaming reflects an expansion of scope; the focus is no longer exclusively on the regulation of medical devices. Newly incorporated key regulatory issues included several currently affecting the medtech sector – such as health data and sustainability.

Federal Council must shift into high gear
The European Medical Device Regulation (MDR) and its Swiss counterpart, the Medical Devices Ordinance (MepV), continue to be a source of debate. The latest amendments to the MDR and its transposition into national law do not resolve weaknesses in the system. «This regulation could not be more complex. It completely overwhelms small and medium-sized companies,» says Dr Daniel Delfosse, Head of Regulation and Innovation at Swiss Medtech. Medical devices are disappearing from the European market and innovations are increasingly being submitted for approval in the U.S. first. A recent ARD program on the MDR reported that Switzerland is not sitting idle and simply observing the supply problems and migration of innovation, and that parliament has acted. «Yes, we have,» confirms Council of States member Damian Müller. Already end of November 2022 the Federal Council received Parliament’s mandate to adapt national law so – in addition to medical devices with a European certificate – Switzerland would recognise medical devices approved by the U.S. Food and Drug Administration (FDA). «Time is running out. Problems are becoming apparent in the hospitals. Many medical devices are already in short supply. And this is just the beginning. The Federal Council must now shift into high gear and implement the mandate,» demands Council of States member Damian Müller.

Sustainability is becoming key for market access
The Federal Council’s Net Zero Target 2050, the counterproposal to the Corporate Responsibility Initiative with reporting obligations (the European «Green Deal») also affects the medtech industry. Sustainability is permeating the entire supply chain – from the extraction of raw materials through production and distribution, to recycling. The real driving force is the market: investors and customers increasingly expect transparency in matters concerning the climate. Large companies in particular are adopting net-zero targets across the entire value chain. The sooner small and medium-sized companies address the issue – even before regulations require them to do so – the greater their chance of remaining part of the supply chain. «Sustainability is becoming a highly relevant market access criterion,» says Dr Beat Vonlanthen, President of Swiss Medtech. «Many Swiss medtech companies have already integrated sustainability into their business model,» the president is pleased to report. They shared their valuable experiences at the National Regulatory Conference in keeping with the motto «From the Industry – For the Industry».