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The SCTO is an independent organisation and is based on a joint initiative of the Swiss National Science Foundation and the Swiss Academy of Medical Sciences.

As of 2017, the SCTO is a research infrastructure of national importance funded by the State Secretariat of Education, Research and Innovation and the Swiss National Science Foundation.

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Symposium 2021

10th SCTO Symposium

Medical devices: Lost in translation?
8 June 2021, online

New regulations on medical devices

Following a one-year delay and the transition period, the European Union’s new Medical Devices Regulation (MDR) will become fully applicable on 26 May 2021. This regulation will bring EU legislation in line with changes in medical science, technical advances, and progress in lawmaking. In the wake of various incidents and scandals involving medical devices, the overall aim of the MDR is to improve the quality and safety of medical devices and thereby improve patient safety.

As the result of the mutual recognition agreement (MRA) between Switzerland and the EU, Switzerland has had regulation that is considered equivalent to the EU’s regulation since 2001. In order to maintain this equivalence, Switzerland also changed its legislation and adapted it to the new EU legislation. In 2020, the Swiss Federal Council adopted the revised Medical Devices Ordinance (MedDO) and a new ordinance on clinical trials with medical devices (ClinO-MD, not available in English). This legislation is intended to improve patient safety and ensure that Swiss manufacturers will continue to have access to the European market.

As a consequence of the coronavirus pandemic, the European Commission postponed the application date of the new MDR. For reasons of consistency, Switzerland’s new legislation will enter into force in stages as well. The SCTO’s 2020 Symposium on medical devices also had to be postponed for a year – yet its topic remains highly relevant in 2021.

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Programme

Together with Bern University Hospital, the University of Bern, and sitem-insel AG (Swiss Institute for Translational and Entrepreneurial Medicine), the SCTO held its 10th symposium on 8 June 2021. National and international experts shared their perspectives on medical devices in clinical development. During the symposium, we addressed many interesting aspects of this topic, including the following:

  • New requirements for medical devices: From clinical development to certification and market access
  • Focus on Switzerland: Where do we stand in clinical development? What is the regulatory framework in Switzerland?

During the second part of our symposium, we looked at the topic from three different perspectives:

  • Patient: A case study of patient-driven medical device development
  • User: User-centred design and artificial intelligence
  • Academic: Unique challenges with medical devices in translational medicine

In addition, our breakout sessions during the lunch break gave participants the chance to learn more about topics specific to Switzerland, for example about access to the Swiss market or what training is needed and what training is currently available in Switzerland.

The presentations and the complete programme of the day are available below.

Presentations

Programme