A product must be traceable with regard to:
- the origin of parts and materials;
- the way in which materials are processed;
- the positioning and distribution of the product following dispatch from the factory.
The Technical Documentation includes the verification documents required to ensure compliance with the general safety and performance requirements set out in Annex I of the MDR. Such documentation should be retained by the manufacturer or its representative in relation to all medical devices, and provided to the appropriate authorities on request.