Modifications in the MDR Era: The Ambiguities of “Significant Change”

ARTICLE SUMMARY:

The EU Medical Device Regulation includes a crucial grace period to help current devices transition to the new standards in a challenging environment. But big questions linger over what device modifications will qualify as a “significant change” nullifying transitional certificates and requiring an MDR-level assessment.

How to handle device modifications is one of the thorniest, yet enduring, regulatory questions in the global medtech arena. 

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