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In our previous blogs, we have discussed about the following topics.

EU MDR 2017/745 is live now. And it is the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745. In today's blog, we are going to discuss about the requirements of instructions for use as per EU MDR 2017/745.

Let's get into the topic.

Instructions for use

In EU MDR 2017/745, Annex I – “General Safety and Performance Requirements”, Chapter III – “Requirements regarding the information supplied with the device”, section 23.4 provides requirements about information in the Instructions for use.

Let’s discuss about few important information’s to be provided in the Instructions for use as per EU MDR 2017/745.

The Instructions for use shall contain the following details, but not limited to the following:

Medical Device’s intended purpose with information about indications, contra-indications, target patient groups, intended users as appropriate.

Information that informs the user and/or patients using the medical device about the warnings, precautions, contra-indications, relevant measures to be taken and limitations in the usage of medical device.

Information about any residual risks, contra-indications & undesirable side effects, including the information to be conveyed to the patient.

If applicable, information allowing healthcare professionals to verify whether the device is suitable for use and to select the corresponding software and accessories. Other information required by the user to use the device appropriately.

Information about requirements with respect to any special facilities and trainings or qualifications of the medical device users and/or other persons.

If applicable, any specifications of the Clinical Benefits to be expected from the medical device and links to the summary of safety and clinical performance. The Performance Characteristics of the device shall also be specified in the Instructions for Use.

Instructions to follow in the event of sterile packaging of the medical device being damaged or unintentionally opened before use. Appropriate instructions for sterilization, if the medical device being supplied is non-sterile with the intention of getting sterilized before use.

Information related to verifying whether the medical device is installed properly and is ready to perform safely, as intended by the manufacturer of medical device.

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If the medical device is intended to be used together with other devices and/or general-purpose equipment’s, such devices shall be identified in the instructions for use to obtain the safe combination. In case if any restrictions to the combinations of device and equipment, it needs to specified in instructions for use.

If the medical device emits radiation for medical purposes, Information about the nature, type and if appropriate, intensity and distributions of the radiation emitted by the medical device shall be provided in the Instructions for Use. Information for protecting the user, patient and other persons from the unintended radiation during the use of medical device shall also be provided

If the medical device is reusable, then information about appropriate processes for reuse shall be specified in the instructions for use. Information shall also be provided to identify when the medical device should not be reused. E.g.: Maximum number of allowable reuses.

If the medical device is single use device, information about the risks that can happen if the device is re-used, shall be captured in the instructions for use.

Information about the warnings or precautions that needs to be taken to facilitate the safe disposal of medical device, it’s accessories and consumables shall be mentioned.

The circumstances in which the lay user needs to consult with healthcare professionals shall be specified, if the medical device is intended to be used by lay users.

Date of issue of the instructions for use shall be specified. If the instruction for use is revised, the revised date and identification of the latest revision shall be specified.

Notice to the user and/or patient shall be provided in the instructions for use, stating that any serious incident with respect to the device should be reported to the manufacturer of the device.

Now I hope you have acquired some basic knowledge about the requirements of instructions for use as per EU MDR 2017/745. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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