The European Commission has published a new edition of the ‘Blue Guide’ on the implementation of EU product rules.
The Blue Guide provides guidance on the interpretation of EU harmonisation measures governing the conditions for placing products on the EU market. The new Guide builds upon the content of the previous edition published in 2000, but has been revised to reflect the current legislative framework, including the Active Implantable Medical Devices Directive 90/385/EEC, the Medical Devices Directive 93/42/EEC and the In Vitro Diagnostic Medical Devices Directive 98/79/EC. It also contains new chapters on the obligations of economic operators and accreditation, as well as completely revised chapters on standardisation and market surveillance.
The revised Guide has been drafted in close cooperation with national authorities, and will be updated regularly. The current version has been released as a 'Commission Notice' in the 'C' Series of the Official Journal and is available here.