[TECH LETTER] Spare parts, repair, refurbishment vs. “fully refurbished”

A recurring question related to the repair of devices is whether external, well-qualified, repair shops may pursue their device reparation activities under the MDR.

Where lies the boundary between “spare part” and “accessory for a medical device? When is repair considered equivalent to “fully refurbishing”?

This Downloadable Techletter aims at clarifying the definitions for these terms and determining the possibilities that remain for healthcare institutions.

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