Policy paper on traceability of medical products

This policy document focuses on the traceability of medical products. It outlines the features of existing traceability systems and offers guidance on developing effective traceability regulations. Recognizing the diverse needs, capacities, and resources of Member States, the document emphasizes that risk mitigation and sustainability strategies will differ across countries. A set of guiding principles is provided to assist Member States in establishing systems tailored to their specific needs and constraints.

Key recommendations include establishing a suitable governance process for traceability systems based on national specificities, such as the regulatory environment and supply chain management. It also stresses the importance of including a costing analysis and a sustainability mechanism in traceability system planning. This is to ensure that costs do not negatively impact patients, governments, supply chain stakeholders, and ultimately, access to medical products. The document also advocates for the use of global standards for product identification, production identification, and data exchange to reduce costs and enhance both national and international interoperability.

The document further delves into various features of traceability systems, including identification, use of global standards, lot/batch-level traceability, unit-level serialization, and more. It also provides strategies for developing a workable traceability regulation, such as risk-benefit analysis, governance and funding, and the use of global standards.