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September 30, 2021

The Schlafender Hase Team

Medical Devices Regulation EU 2017/745

Medical Devices Regulation (MDR) updates represent a step towards higher labeling standards. At the same time, they create challenges and a potential need for additional resources. Instructions for Use (IFU) must be flawless, not only because they need to comply with regulation to avoid legal liabilities, but above all, to ensure optimal use of the medical device.

Annex I Chapter III of the MDR summarizes the requirements for labeling, including the IFU. MDR requirements on user and patient labeling are highly user centric. IFUs must not only be safe and transparent, it is essential they are also clear, understandable and accurate.

Risks, limitations, contraindications, precautions, warnings and special storage conditions are required to be communicated to the user immediately upon first contact with the packed device – which means directly on the label, prior to unpacking. In cases where directions are too large for a device label, they need to be completely and properly explained in the IFU. For example, MDR, compared to the former Medical Device Directive (MDD), requires stringent instructions on how to declare and handle sterile packaging. These instructions require additional clearly explained directions in the IFU.

IFUs that are up to date, well-structured and easily understood are not only important from a scientific perspective but are also valuable from a marketing perspective. IFUs that are not easily understood or that lead to incorrect usage negatively impact sales. A medical device that is not easy to use because of a suboptimal IFU is also not an easy sell.

Using an automated proofreading solution will help ensure documents are completely and accurately updated. Text verification tools will also assist in reducing time spent reviewing what are often large and complex IFU updates by up to 85%, reducing the requirement for additional resources.

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