Traceability of medical devices

Medical device traceability refers to the ability to track and identify medical devices' history, location, and application and the raw materials they are made from. Medical device companies and regulators need to easily identify each component's history, where it comes from, and what it is used for. Traceability is important in ensuring product quality and safety and allows authorities to identify counterfeit products more easily. Traceability throughout the whole lifecycle of a product is also known as closed-loop traceability.

To keep track of a medical device through all lifecycle stages, in the EU, every product is attributed a UDI – unique device identification registration number, which is then registered into the EUDAMED database. In the EU, all medical device manufacturers need to ensure that closed-loop-traceability is kept. In the US, this is not mandatory for all product types.

How does structured content help?

With the help of structured content, it is easier to keep track of all changes made to the documentation of a medical device throughout its lifecycle. When managing a large variety of medical products for different markets, ensuring that the correct identification number has been added throughout the documentation of said medical devices is cumbersome. Structured content helps organizations automate content creation and updating, eliminating uncertainty in dealing with documentation.

Key benefits

• Avoid accidental and unintended content alteration by ensuring clear access rights for content authoring, reviewing and approving

• Easily track where each content component was (re)used in your medical device documentation

• Make quick changes to source content that will disseminate to all content instances