The European Commission announced a one-year postponement of the application date for the new Medical Devices Regulation (MDR). The MDR was due to go into force by the end of May for all European companies developing and manufacturing these products for healthcare systems. The EC proposal will be sent to Parliament and Council in early April for approval.
This measure aims to take pressure off national authorities, notified bodies, manufacturers and other stakeholders so they can focus fully on urgent priorities related to the Covid-19 crisis.
A few months ago, the CataloniaBio & HealthTech Regulatory Affairs Workgroup held a training session on the application of MDR with one of the leading European experts, Dr Bassil Akra from TÜV SÜD Product Service GmbH.
In Catalonia, there are 176 start-ups and companies working on research and development of medical devices, diagnostics and other technologies, according to the 2017 Biocat Report.
Infographic: © CataloniaBio & HealthTech
Comments