MEDICAL | MEDTECH | BIOTECH
The fields of medicine in general and of Medtech as well as Biotech in particular are characterised by a high (and continuously increasing) number of regulations. This poses considerable challenges to all stakeholders with regard to identifying the relevant rules and regulations and complying with them. | |
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OUR SERVICES
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 Ordinance on Medical Devices;
- Qualification and classification of software as a medical device in particular;
- Data protection matters (Swiss Data Protection Act, EU General Regulation on Data Protection GDPR)
- Legal and regulatory framework for conformity assessments for medical devices in Switzerland and the EU;
- 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.
