Technical File - Critical Supplier List Questions


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What is the definition of critical supplier as it relates to the technical file for MDR submission? I can't find any reference to critical suppliers in MDR. We've been getting mixed opinions on what is considered a critical supplier to put into our technical file.

Thanks in advance.

Sidney Vianna

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Have you done a search? This issue has been discussed a number of times. In the absence of an official, authoritative definition, go with:

2.3 Critical supplier A critical supplier is a supplier delivering materials, components, or services that may influence the safety or performance of the device [2]. Note In Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices instead of “critical” also the term “crucial” is used: subcontractors in charge of processes which are essential for ensuring compliance with legal requirements (‘critical subcontractor’) or a supplier of crucial components or of the entire devices (both: ‘crucial supplier’).

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Look at your DFMEA and identify parts that, if they fail, it may lead to serious injury or death. Suppliers of these parts are critical or high risk suppliers since any non-conformances with these parts may lead to serious injury or death. This is the safety aspect.

For parts that may affect the performance of the device, it could be a broad range of harms such as delay in treatment, property damage or minor injury - These suppliers maybe deemed as "non-critical" suppliers.
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