Under the new EU MDR, all medical devices must be labeled in accordance with the EU MDR medical device labelling requirements. Labels must include the device name, model number, serial number, manufacturer name and address, CE mark, any applicable warnings and instructions for use, the date of manufacture, and the batch number. Labels must also include a unique device identifier (UDI) which is assigned to each device when it is released onto the market. The UDI should be applied to the label, instructions for use, and the device packaging.
Medical device symbols should be represented in all medical device labelling and packaging material. Medical device symbols is a significant regulatory requirements followed in every medical device regulation. EU MDR 2017/745 has new requirements that looks for various kinds of medical device symbols to be indicated on the medical device labelling. Medical device symbols creates a necessity to translate the information provided on the labels into multiple languages, depending on where the device is made available. This requirement can be dealt with by using medical device symbols. The use of medical device symbols on the label as an alternative to written language is mentioned in GSPR of EU MDR in 23.1. (h), as medical device symbols are efficient, cost saving and internationally understood concepts to convey the required information to the user of a medical device.
The medical device labelling requirements for medical devices according to the EU MDR are as follows:
