Under the EU MDR (EU 2017/745) and IVDR (EU 2017/746) , all medical devices must have an Instructions for Use (IFU) that describes the device’s intended purpose, use, proper maintenance, and potential risks. The IFU must also include detailed information on how to safely use the device and how to manage any risks associated with its use as needed in Medical device lFU. The medical device IFU must also provide information on the device’s shelf life, storage requirements, and any applicable warnings and precautions. In case of active devices this is often referred to as user manual.
The IFU (Instructions for Use) for medical devices or user manual incase of active devices must meet the requirements laid out in Annex I, Section 1.6 of the European Medical Device Regulation (MDR). In particular, the medical device IFU must provide clear and detailed instructions for the safe and appropriate use of the device, including:
The following steps should be followed to prepare an medical device IFU for a medical device as per in EU MDR:
For further information on how to prepare medical device IFU based on international standards you can refer: https://www.iso.org/obp/ui/fr/#iso:std:iso:20417:ed-1:v2:en
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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