Harmonised address labelling required from all medical devices manufacturers

The MDD 9342/EEC Essential Requirements state that the manufacturer has to place his name and address on the product label and in the instruction for use. In order to achieve a common interpretation of this requirement, the Central Management Committee issued a decision requesting all manufacturers and authorized representatives to provide their address with the following elements:

- street/road
- number/house/floor
- postal code
- city
- state/region
- country

The Competent Authorities request that manufacturers implement this decision no later by September 2012.