SFL’s Head of Public Affairs Niklaus Wagner is attending the event MDR/IVDR 2020, implant files and beyond- are you ready? (29 May 2019, Bern). A panel of experts will discuss the medical device industry’s awareness of the increased requirements and the possible gaps and loopholes that could affect compliance due to the new EU and Swiss medical device regulations. The MDR will take full effect in less than one year on 26 May 2020, with the IVDR following on 26 May 2022.

SFL is closely following the implementation of the MDR/IVDR to identify emerging compliance challenges for devices in the EU and the Swiss markets, and provides strategic support for companies to ensure readiness and a smooth transition. In this context, SFL experts also evaluate the impact of potential changes in the mutual recognition and framework agreement(s) between Switzerland and the EU, and how individual companies can prepare for different scenarios.

SFL provides integrated solutions for medical devices in response to political and legislative changes in the EU and Switzerland. Contact us to discuss how SFL can support to prepare your business against disruption when the new MDR/IVDR comes into full effect.