Third Party Event New medtech regulations

Countdown to the new Diagnostics Regulation: What challenges for patients, users and manufacturers?


In the midst of a period of significant change in the EU in vitro diagnostic regulatory landscape, with the IVDR transition deadline fast approaching on 26 May 2022, the COVID-19 pandemic has drawn the world’s attention to diagnostics. To mark the 18-month countdown to the IVDR transition deadline, this event will explore the important role of diagnostics in adapting therapies, as well as the regulatory challenges presented by the new EU regulation.

The second edition of the Incisive Health Morning Club will take place on 26 November 2020 with Oliver Bisazza, Director Regulations and Industrial Policy at MedTech Europe, Adela Maghear, Senior EU Affairs Officer at the European Cancer Patient Coalition, and Prof. Elizabeth Macintyre, Board Member at BioMed Alliance.

In the upcoming discussion, Oliver Bisazza will build on his expertise in the EU in vitro diagnostic regulatory landscape, while Adela Maghear will provide a patient perspective on the subject, and Prof. Elizabeth Macintyre will discuss the healthcare professionals’ viewpoint, generating an interactive discussion on the current challenges faced by those preparing for the new regulations, as well as exploring what the future landscape may hold.

The event will be held on Thursday, 26 November 2020, 8:30 – 9:30am CET, using a secure Zoom platform. Please RSVP to [email protected] by 23 November, to receive the relevant Zoom details to join.