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BioReg advises on all issues related to Quality Agreements with Critical Suppliers. The legal definition of individual and mutual responsibilities within the legal document is of the utmost importance for the company’s success.

Clients often ask us what is considered a “critical supplier” under MDR/IVDR and what are the manufacturers’ obligations regarding such companies.
The term “critical supplier” or “critical subcontractor” is not defined in MDR. Likewise, ISO 13485 and the Blue Guide don’t offer any definition. However, the Notified Bodies Operations Group – NBOG’s Best Practice Guide (2010) defines a critical supplier as a supplier delivering materials, components, or services that may influence the safety and performance of the device. In the context of the audit of medical device manufacturers, a critical supplier is a product or service supplier. Failure to meet specified requirements could cause unreasonable risk to the patient, clinician, or others or cause significant performance degradation.

This can include suppliers of services which are needed for compliance with QMS or regulatory requirements.
We advise you to define “critical” in terms of the risk involved. For example, subcontractors that provide high-risk processes, such as sterilization, manufacturing, packaging, or software development, should be considered for the critical supplier category.

Manufacturers should know that:

  • Critical suppliers are likely candidates for the unannounced audits by Notified Bodies (NBs)
  • Authorized Representatives and NBs expect to see the list of critical suppliers as part of the QMS documentation
  • They should audit their critical suppliers at least once every three years as a good quality practice. Such suppliers will usually have a certified quality system
  • They should have Quality Agreements in place with all critical suppliers


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