The Federal Council will draft a new Law to improve quality and safety of medical devices
During its meeting of the 2nd of March, the Swiss Federal Council has decided to open a consultation procedure to review the Act on Therapeutic Products, which concerns the regulation for marketing and surveillance for medical devices. The new law will incorporate the European regulation and aims at improving quality and safety of technologies used.
The Law will strengthen requirements for all stakeholders involved in the process of utilization and marketing of medical devices. Manufacturers will be subject to higher requirements in terms of clinical studies and evidence to prove efficacy and safety of high-risk technologies. In addition, criteria for approval, traceability and post-marketing surveillance of devices will be strengthened and a centralized European database on medical devices will collect and make public all relevant information of European and Swiss products marketed in Europe.