OUR SERVICES

We support all stakeholders in the medical, medtech (including software) and biotech fields in navigating efficiently and focused in the 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 Ordinance on Medical Devices;
• Doctors and other medical professions: Licenses, permits and authorisations, practice start-ups, practice acquisitions, contract drafting and management;
• Data protection matters (Swiss Data Protection Act, EU General Regulation on Data Protection GDPR)
• Representation in proceedings vis-à-vis Swissmedic;
• Matters related to placing medical devices and biotech products on the Swiss and EU markets;
  
• 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;
• Analyses of potential risks in the light of applicable laws, rules and regulations, including the relevant international framework.