Can you identify your critical suppliers, link each to their respective product codes and global registration status? Many medical device regulatory affairs teams struggle to connect these dots.
Firstly, who is a critical supplier and why are they important?
“2.2 Critical supplier: A critical supplier is a supplier delivering materials, components, or services that may influence the safety and performance of the device. Note: In the context of the audit of medical device manufacturers, a critical supplier is a supplier of a product or service, the failure of which 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, which are needed for compliance with QMS or regulatory requirements, e.g. internal audit contractors or Authorised Representatives.”
Compilation of MDR compliant technical documentation necessitates identification of all sites, including suppliers where design and manufacturing activities are performed.
Annex VII of the MDR requires your notified body to “identify links between, and allocation of responsibilities among, the various manufacturing sites, and identify relevant suppliers of the manufacturer, and consider the need to specifically audit any of those suppliers”
“…if not already covered by the audit programme, audit the control of processes on the premises of the manufacturer’s suppliers, when the conformity of finished devices is significantly influenced by the activity of suppliers and, in particular when the manufacturer cannot demonstrate sufficient control over its suppliers”. Notified bodies are expected to perform unannounced audits of your named suppliers, where applicable.
Cross-functional deliberations on the strategy and approach for ensuring medical device suppliers are identified, controlled and managed appropriately via QMS will only succeed if the data is accurately connected within your regulatory information management (RIM) system. Global and regional regulatory operations teams support this process by maintaining adequate linkage, tracking and data retrieval of supplier information per product code.
Feel free to contact me at firstname.lastname@example.org for information on how to support supplier data management.