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:
For more information on medical device symbols and labelling, please click the following link https://mavenprofserv.com/unique-device-identifier-for-medical-devices/
Some of the newly added medical device symbols mentioned in ISO 15223-1:2016 which should be addressed on the label as per Annex I of EU MDR are mentioned below along with their MDR clauses:
|International Symbol||Corresponding GSPR Clause|
|23.2 q) An indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’;|
|23.2 e) where applicable, an indication that the device contains or incorporates:
|23.2 e) Indicates a medical device that contains substances that can be carcinogenic, mutagenic, toxic to reproduction (CMR), or substances with endocrine disrupting properties|
|23.2 l) if the device is supplied sterile, an indication of its sterile state and the sterilization method;|
|MDR Article 16 Point 3|
|Indicates a medical device that may be used multiple times (multiple procedures) on a single patient|
Medical device labeling is an information supplied by the manufacturer that is associated with or affixed with a medical device or container and wrappers for the correct and safe use of a device by the intended user.
This means a medical device label could actually be:
EU MDR- Annex – I, Chapter III, 23. Label and instruction for use 23.2 – Information on Label- provides stringent requirements for medical device labeling. The legislative References regarding the medical device labeling in context to EU MDR 2017/745 under Annex I, chapter III, 23.1 & 23.2 – Information on the label shall bear following particulars mentioned in the below medical device labeling template.
Usage of symbols in labels helps to communicate quickly which are efficient, cost saving and internationally understood concepts to convey the required information to the user of a medical device. As labels provide critical risk/benefit information as well as clear instruction for safe use. These symbols used in labels are also used in other range of formats like leaflets, user manuals, brochures.
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