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TÜV Rheinland Italy participates to 1MED’s webinar “Medical Devices and clinical data. Focus on the application of the new european regulations’ requirements”

19.11.2021Pogliano Milanese (MI)

The MedTech industry is increasingly crucial in sustaining Europe’s socio-economic well-being, allowing people to live better and longer; however, the branch is very fragmented and highly regulated, and the rules must guarantee to patients and users the access to medical devices and safe and efficient IVDs. In order to do that, the producers must prove the safety of their products, with a keen attention to post-market’s surveillance activities. The new European regulations (MDR and IVDR) contain stricter requirements for the generation of clinical data, in terms of both quality and quantity of data collection, along with the monitoring of security and performance data of marketed medical devices.

In order to help companies to juggle in this evolving regulatory framework, 1MED organised a roundtable that involves national experts – amongst them Simone Antonini, Regulatory Medical Coordinator of TÜV Rheinland Italia – to discuss the common misconceptions and help clarify the Ethical Committee, the Notified Bodies and Competent Authorities’ expectations concerning the generation of pre- and post-market clinical data.

The event will take place the 30th of November 2021 at 11:00 a.m.

For further information, click here.