Legal & Regulatory - Swiss Medtech Website
To further improve patient safety, new EU regulations - MDR for medical products and IVDR for in vitro diagnostics (incl. three-year and five-year transitional periods) - entered into force on 25 May 2017. This will, among other things, intensify the regulation of market qualification for "higher" classified products. Even more demanding requirements for clinical evidence now apply. The entire medtech sector will be strongly challenged by the implementation of the two comprehensive regulations in the coming years. In addition, systematic cost-benefit assessments of medical procedures through Health Technology Assessments (HTAs) are becoming increasingly important in the face of the cost pressures on healthcare. Compliance requirements concerning human interaction are also on the rise. One example is the Swiss Medtech Code for Ethical Business Conduct which specifies provisions governing collaboration between industry, medical professionals, and institutions.
Two experienced experts
The new «Legal, Compliance and Reimbursement» Specialist Unit supports members as they navigate the growing regulatory jungle - as well as in other complex legal situations. Joerg Baumann, General Counsel and Deputy Managing Director, provides information and advice on queries regarding common legal, regulatory, and tariff issues. He also oversees mediation proceedings concerning the Swiss Medtech Code on Ethical Business Conduct. Peter Studer (formerly of Swissmedic ) is responsible for the field of medical product regulation in Switzerland and Europe, and he ensures and maintains relationships with relevant partner organizations at home and abroad. As Senior Expert Regulation, he manages the development of an MDR / IVD Swiss Implementation Taskforce - one of Swiss Medtech's key projects. The services provided will include information, educational, and public events offered at various seminars, conferences, workshops, and specialist conferences.
Take a position and negotiate
«Legal, Compliance and Reimbursement» concentrates on improving general market conditions together with the Specialist Groups made up of experts from member companies. One focus is on reducing unnecessary bureaucracy (ex. for innovation financing) in order to ensure patient access to products and therapies. To this end, the association actively defends their position when dealing with the federal government and other authorities, creates position papers, and negotiates fair conditions.