European Commission delays its MDR by one year to focus on the Coronavirus, but leave labeling and database compliance deadlines unchanged.

March 25, 2020 the European Commission announced that they are working on “a proposal to postpone the date of application of the MDR for one year”.  The proposal is expected to be submitted to the European Parliament in early April. The postponement seeks to “temporarily alleviate the burden on available resources” in the healthcare industry during the COVID-19 epidemic. To view the EC statement click here.

What is the “Date of Application of the MDR”?

The obligation for UDI assignment applies from the date of application, i.e. currently May 26, 2020 for the MDR. Manufacturers are required to allocate UDIs and Basic UDI-DIs to all of their devices by the date of application. The proposal to postpone would move the date of application to May 26, 2021.

The obligations for placing UDI carriers on device labels, direct marking of reusable devices, and submission of UDI data to EUDAMED are not impacted by this postponement. The table below outlines all current labeling and database compliance deadlines.

Preparing for MDR Requirements with HIBCC

HIBCC will be conducting a series of webinars on MDR related topics to help our labelers better prepare for the upcoming deadlines. Information on the webinars will be released on the HIBCC website as it becomes available.

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