EC publishes MDR guidance on Custom-Made Devices

March 15, 2021
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In March 2021 the European Commission published a guidance document titled “Questions and Answers on Custom-Made Devices”. The document includes high-level information “aimed at addressing the most pertinent questions relating to custom-made devices falling under the MDR”.

To view the guidance on Custom-Made Devices click here.

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