When discussing medical device regulation, it is often said that Class I and IIa devices do not need to be accompanied by instructions for use. But is this really the case? Annex I MDR, section 23.1. (d) states that "instructions for use (shall) not be required for Class I and IIa devices unless such instructions are necessary for the safe use of such devices and unless otherwise specified elsewhere in this section.” So the simple assumption that a manufacturer can or cannot issue IFU as it pleases does not apply.
The manufacturer must justify in the technical documentation that it is not necessary to issue one and that the device can still be used safely and effectively. But what about the situation when the manufacturer wants to get rid of IFU (e.g. for incontinence devices) but it has a need to communicate to the user in the form of pictograms? Does the pictogram IFU have any solutions? The manufacturer then has to choose, especially on the basis of the risk management process, whether a manual is needed - and then provide it with all the requirements of the section 23.4 Annex I MDR. It may, of course, add pictograms when appropriate and necessary.
We see two provisions as highly problematic in this context. According to section 23.3. (j), for sterile devices, the packaging should contain a guidance to check the instructions for use for what to do if the sterile packaging is damaged or opened. This largely negates the possibility of the manufacturer not issuing IFU for a Class Is or IIa sterile device. There is also the question of how to interpret the second part of the quoted exception: "...and unless otherwise provided elsewhere in this section." I believe that the point in this case means the whole of paragraph 23. In such a case, IFU is almost always required for sterile devices. Perhaps only in the case of a positive opinion of the notified body could this information be placed directly on the packaging. The second 'unfinished' provision is the need to issue IFU 'on paper' according to section 23.1(f) of Annex I of the MDR for software. Unfortunately, the exemptions allowing the issuance of instructions for use in electronic format are limited in Regulation (EU) 2021/2226 to professional users only. According to our information, an amendment to this Regulation is currently under preparation. Hopefully, it will bring the necessary streamlining of requirements for software manufacturers in this respect. We will let you know in due course when the details of the forthcoming changes are known.
Author: Aleš Martinovský
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