Printing medical devices under the MDR: changed world?

Jan-Paul van Loon

by Jan-Paul van Loon, Qserve Consultancy BV

On May 26, 2020, the new Medical Device Regulation (MDR) will come into force, and Hospitals and Industry are getting increasingly nervous as this date approaches. Although the MDR is not particularly stricter than the current Medical Device Directive (MDD) for custom-made device manufacturers, there are differences, as for example the necessity of a “Person Responsible for Regulatory Compliance”, and more extensive Post-Market Surveillance requirements.

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