Guidelines
The enhanced requirements and any related labelling changes introduced by the EU MDR will have differing impacts on costs and resource demands for you as a manufacturer.
The downloadable table can be used as a high level guide to indicate what requirements of GSPR 23 might apply to your device. However, accurate and compliant labelling is essential, so it’s important to carefully consider all the requirements of GSPR 23 in relation to your specific device, ensuring that all applicable components are present on your label and in your instructions for use.