On the 17th November 2107, the harmonised standard EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements, replaced the previous EN 980 on the European Official Journal. This online product is currently under review. Please, contact us if you want to purchase the updated version.
Medical Device Directive (MDD) Logo's Package
This downloadable pack contains all the logos you will need to deliver information and Instruction to the user of your Medical Device. It also Contains checklists to help you identify the symbols you require.
MDD explicitly requires the use of Logos to deliver information and instruction to the user.
In this package you will find checklists to help you to identify the symbols you require and an example of each applicable logo.
You will also need the CE marking logo, which is available- free of charge - on the Conformance shop.
This package also includes:
a checklist of the MDD Esessential Helath and Safety Requirements, in which we have highlighted the requirements for the information and instructions.
a checklist based on the requirements of the standard EN1041 - this information is supplied by the manufacturer of medical devices
a checklist based on the requirements of the standard EN 980 - Symbols for use in the labelling of medical devices.