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EC publishes guidance addressing MDR requirements in the event EUDAMED is not fully functional

The European Commission (EC) released a guidance on the application and implementation of certain provisions in the Medical Device Regulation (MDR) in the absence of EUDAMED. This guidance “intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.”

In 2019 the EC announced that the launch of EUDAMED would be delayed by two years (from May 2020 to May 2022). Subsequently the MDR date of application was delayed by one year (May 2020 to May 2021) in an effort to direct more resources to the COVID-19 pandemic.

To view the guidance document click here [1]

To learn more about HIBCC and UDI, visit www.hibcc.eu [2] or contact HIBCC directly at udisupport@hibcc.eu or +1 (602) 381-1091.