Good day Shikha,
Not sure what you mean by 'how are we defining material specifications in EU MDR' - but it could be a number of different aspects. Indeed it could be material, resin, composition, type, concentration, and any impact this change may have on the safety and performance of the finished device. Depending on the device type and the materials which are in question being changed, this could result in a number of different approaches. As an example, materials being changed in an instrument such as electronic components or housing may not be significant, but changes to IC chip or material of PCB/solder could be. Or a physical material from a catheter where changing from one grade of PVC to another, changing durometer of silicone, or increasing concentration of a type of resin. If you have an EU MDD certificate until May 2024, you should really have this discussion with your Notified Body because many are taking a very conservative approach to changes - regardless of what the MDCG states for significant change. If any change is being made, there has to be substantial justification and rationale for why a change is being made to an EU MDD cert product when the compliance date is 15 days away and everyone is moving toward EU MDR compliance.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 07-May-2021 19:03
From: Shikha Malik
Subject: Material Specification- EU MDR
Hello all,
I am bit confused while assessing a change to see if it qualifies for EU MDR or not. The product is currently approved under EU MDD till May 2024 however, there is a planned material change per the 'MDCG guidance document-Significant change', we need to assess if the material specifications are changing or not. How are we defining material specification in EU MDR ? Does it mean changing the specified material/resin, or a change to the safety/performance specifications to which the material must adhere ?
Any leads would be valuable.
Thanks!
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Shikha Malik
Regulatory Affairs Specialist II
Abbott
Dallas TX
United States
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