We support all economic operators and other stakeholders in the medical, Medtech and biotech fields in navigating efficiently and focused in the relevant, challenging regulatory environment, both in Switzerland and the European Union (EU). In addition to general corporate legal issues, we cover the following matters in particular:

  • EU Regulations 2017/745 on Medical Devices (MDR) and 2017/746 on In Vitro Diagnostics (IVDR), including their preceding legal acts;
  • The Swiss Therapeutic Products Act and the Swiss Regulation on Medical Devices, including their recent/scheduled amendments;
  • Legal and regulatory framework for conformity assessments for medical devices in Switzerland and the EU;
  • External provision of the function of a «Person responsible for regulatory compliance» for small and medium-sized Medtech enterprises;
  • Placing medical devices and biotech products on the Swiss and EU markets;
  • Legal support regarding conduct of clinical investigations or assessments/trials, including obtaining the permits required;
  • Traffic of medical devices and biotech products between the EU and Switzerland and other non-member states;
  • The EU–Switzerland Mutual Recognition Agreement (MRA);
  • Provisions on transparency and integrity as well as ethics and similar principles related to medicine, Medtech and Biotech;
  • All private and competition law matters in these fields.