Section G — IFU, SSCP, labelling and other information supplied with the device
Source: MDCG-2020-01.pdf pages 22-24 (document: MDCG 2020-13)
Section G: IFU, SSCP, labelling and other information supplied with the device
Information materials supplied by the manufacturer and the instructions for use:
Describe what has been reviewed – IFU, promotional materials (if available), SSCP, labelling etc. In case several documents have been assessed, identify answers to the questions below for each of the documents.1
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Intended purpose:
Does the clinical evidence support this?
Intended patient population:
Who is the intended patient population? Does the clinical evidence support this? Are all the appropriate/relevant restrictions, warnings or contraindications in place?
Intended users:
Is the device to be used by healthcare professionals or lay users? Does the IFU provide all the appropriate/relevant information for the intended user? Has the manufacturer taken into account the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users). Is any training for users required as a risk control measure? If not, is this justified with respect to the risk management file and the clinical evaluation?
Limitations:
Has the manufacturer adequately/clearly described any limitations for the device use? Does the device require any specific limitations?
Contraindications:
Have contraindications been adequately/clearly described? Are any further contraindications necessary?
Warnings and precautions:
Have warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that may affect safety been adequately descried?
Does the information supplied by the manufacturer adequately/clearly provide the safety and performance information relevant to the user, or any other person, as appropriate/relevant?
Is the estimation of associated risks and residual risk adequate? Is this estimation quantitative (i.e. a percentage rate or rate with a confidence interval) or qualitative? Is the description appropriate for patients and users? Is the information provided to the end user written in a clear and understandable way (instructions of use, indications, and warnings)?
Is the IFU and other information materials supplied by the manufacturer aligned with the other parts of the technical documentation?
Consider:
- the clinical evaluation (the device description used for the clinical evaluation, other contents of the clinical evaluation report).
- the available clinical data (such as the public registration and results of clinical investigations, publications, PMCF studies, etc.).
- PMS report or PSUR.
- the risk management file.
Non-compliances identified and resolved for this section may be briefly described in this box
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IFU, promotional materials, labelling are:
- Compliant with the applicable requirements of the MDR:
Include any relevant comments
- Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below:
Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.