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The Blue Guide has been a long-standing reference for how to implement and interpret EU rules. It has now been updated to reflect the current situation in Europe. For example, it now has a section that references consequences of the UK’s withdrawal from the European Union.
Below are several highlights from the new 2022 version of the Blue Guide. We recommend bookmarking the 2022 version for future reference as needed.
The Blue Guide has been an important reference point for interpretation around ‘placing on the market’, and the 2022 version generally keeps the same language around this concept.
The 2022 version keeps the same text around the authorized representative, importer and distributor.
Note that where there are differences between the Blue Guide and the legislation, the legislation prevails:
“This is intended purely as a guidance document – only the text of the Union harmonisation act itself has legal force.”
For example, both versions of the Blue Guide state that a European manufacturer may appoint an Authorized Representative to fulfill certain tasks. However, the MDR/IVDR define the Authorized Representative as:
‘any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation’
That said, the Blue Guide remains an invaluable reference tool for interpreting EU Regulations.
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