Back

Supply chain identification

We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.

According to MDR Article 25, distributors and importers shall cooperate with manufacturers or Authorised Representatives to achieve an appropriate level of traceability of devices.

Economic operators shall be able to identify the following to the competent authority:

  • any economic operator to whom they have directly supplied a device;
  • any economic operator who has provided them directly with a device;
  • any health institution or healthcare professional to which they have provided a device directly.

BioReg can help you map complex supply chain interrelationships and efficiently define the obligations and responsibilities of each supply chain subject.

Question & Answers

Question: What is considered a “critical supplier” under MDR, and what are the manufacturers’ obligations regarding such companies?

Response: The term “critical supplier” or “critical subcontractor” (we use these two terms here as synonyms) is not defined in MDR. Unfortunately, ISO 13485 does not offer a definition either. Likewise, the Blue Guide is silent on this issue.
However, the Notified Bodies Operations Group – NBOG’s Best Practice Guide (2010) defines critical suppliers 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 supplier of a product or service whose failure to meet specified requirements could cause unreasonable risk to the patient, clinician, or others or could cause a significant degradation in performance. This can include suppliers of services needed for compliance with QMS or regulatory requirements.

Since this is a very broad and vague definition, the manufacturers are left to their own devices to define their critical suppliers.

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.
Please note 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.
• Manufacturers 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.
• Manufacturers should have Quality Agreements in place, at least with critical suppliers.

 

 

CONTACT US

In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

Hi, We are BioReg website cookies and we are here to provide necessary website functionality, improve your experience and analyze our traffic. By using our website, you agree to our Privacy Policy. 10
Accept
Reject