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EU-MDR Annex I Requirement 10.1(d)

#1
EU-MDR regulation 2017/745, Annex I Requirement 10.1(d) states that " the impact of processes on material properties;"? What does it actually mean?
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
It means that processes can change material properties, and this has to be taken into consideration into the biological evaluation (usually requiring chemical and physical characterization). See ISO 10993-1.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
I see it in a more general way (exceeding biocompatibility aspects). In general, attention is required through design and manufacturing to whether processes (not just manufacturing but also shipping, storage etc., perhaps even usage) affect material properties. Awareness is required to the fact that material properties don't necessarily stay the same as when these materials are received by the device manufacturer.
 
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