CEN/CLC/TC 3/WG 3 - Traceability
Traceability
General Information
Frequently Asked Questions
CEN/CLC/TC 3/WG 3 is a Working Group within the European Committee for Standardization (CEN). It is named "Traceability". This committee has published 1 standards.
CEN/CLC/TC 3/WG 3 develops CEN standards in the area of Information technology. Currently, there are 1 published standards from this working group.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.
This Technical Report describes the current situation for medical device traceability in Europe and identifies key elements to establish a comprehensive European traceability system that would provide full traceability to the individual patient level.
This Technical Report applies to medical devices, active implantable medical devices and in vitro diagnostic medical devices, including their accessories. Other devices which are custom-made or intended for clinical investigations and those in vitro diagnostic medical devices which are manufactured in health institutions and for performance evaluation are out of the scope of this document.
- Technical specification12 pagesEnglish languagee-Library read for1 day