IMDRF releases guidance on choosing and evaluating suppliers
The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, evaluate, and monitor suppliers throughout the life cycle of medical devices.
The guidance is aimed at medical device manufacturers and may also be beneficial for regulatory authorities, auditing organizations, and suppliers. The document covers all medical devices, including in vitro diagnostics and combination products.
The guidance advises familiarity with the International Organization for Standardization’s (ISO) 13485, as “several medical device quality management system regulations” are harmonized with this standard. This standard covers the quality management system (QMS) for medical devices. It also encourages manufacturers to refer to ISO/Technical Committee’s (TC) 210 standard for practical guidance on implementing ISO 13485.
This guidance revises a previous version of the Global Harmonization Task Force (GHTF) document titled “Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers,” which was issued in December 2008. The update reflects the current state of the art and incorporates insights gained from the initial version.
The guidance states that “the appropriate control of suppliers is essential element/necessary to ensure medical device safety and performance. Therefore, manufacturers should establish and implement a robust purchasing process including supplier control and management. The intent of the purchasing process is to ensure that purchased, subcontracted, or otherwise received products and/or services conform to specified requirements.”
All suppliers, whether internal or external to the manufacturer’s organization, must be under the manufacturer’s control, according to the guidance. It further notes that while these oversight activities can be carried out by an independent party, “the manufacturer retains the ultimate responsibility for all functions within their own quality management system including the purchasing process.”
The process of establishing controls involves planning; selecting, evaluating, and accepting potential suppliers; and monitoring them.
The guidance states that manufacturers should carefully assess potential suppliers by evaluating their business and operational capabilities, including their technological competence. This is essential to ensure that the supplier can provide products and services that meet the required standards for quality, safety, performance, and reliability. Additionally, these evaluations should consider the supplier's projected growth and their disaster-planning strategies.
In terms of supplier acceptance and approval, the guidance states that no supplier can be fully approved until all selection criteria have been met and all necessary controls have been established. It is considered good practice for the selection criteria and relevant controls to be reviewed and acknowledged or approved by the supplier. Records of these activities should be maintained.
A formal record of the manufacturer’s acceptance or approval of the supplier, signed by an authorized person, must be clearly documented. This record should include details such as the supplier’s name, the date and expiry of the acceptance or approval, the scope of the acceptance or approval, and any restrictions. Only approved suppliers are permitted to be used.
Manufacturers or third parties can conduct these evaluations either through desktop reviews which involve off-site review of documents, on site or remote audits, or product testing.
The guidance emphasizes the importance of continuous monitoring and re-evaluation of suppliers once they have been approved. It states that organizations must ensure that the products and services provided by suppliers consistently meet the established selection criteria. Typically, monitoring and measurement inputs include inspecting, verifying, and testing incoming products and services to confirm compliance with critical attributes and confirming that testing is being performed by the supplier or their contractor.
The guidance also provides examples of how the guidance can work in practice for a sterile product and a low-risk component of a medical device.
