[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 Tech’letter aims at clarifying the definitions for these terms and determining the possibilities that remain for health care institutions.