Electronic user manual for medical devices: what you need to know
The year 2022 has opened with the new (and long-awaited) EU Regulation 2021/2226 on instructions for use (IFU) in electronic form for medical devices. Entering into force on January 4, 2022, the regulation replaced the former EU regulation. 207/2012 and aims to adapt the use of the electronic IFU to EU Regulation 2017/745 (MDR) in accordance with recent technological advances as well as the principles of the green economy. In particular, the EU regulation. 2021/2226 (IFUR) impacts medical software, regulating for the first time the use of electronic IFUs for software as medical devices (SAMD) such as apps.
What the rules say
EU regulation. 2021/2226 lays down the precise conditions that the manufacturer must comply with in order to provide the user with a user manual in electronic form, as well as certain requirements concerning their content and their display on the manufacturers’ websites. An instruction manual in electronic form (EIFU), according to Article 2 of the Regulation, means “instructions for use displayed in electronic form by the device, contained in a portable electronic storage medium provided by the manufacturer with the device, or made available through software or a website“. It is clear that the EIFU must also contain all the information provided for as mandatory for the drafting of the instructions for use of any medical device by appendix I, chapter III, point 23.4. of the MDR.
Medical devices to which the instructions for use apply
Article 3 provides a complete list of the types of medical devices and their accessories to which the regulation may apply. These are:
- Implantable medical devices (IMD), as defined in Article 2(5) of the MDR;
- Active implantable medical devices, as defined in Article 2, paragraphs 4 and 5, of the MDR;
- Fixed medical devices, defined in Article 2(3) of Reg. EU 2021/2226 as “devices and their accessories which are intended to be installed, fixed or otherwise fixed at a specific location in a healthcare facility so that they cannot be moved from that location or detached without the aid of tools or devices, and which are not specifically intended for use within a mobile healthcare facility”
- Medical devices equipped with an integrated system visually displaying the instructions for use
- software regulated by the MDR.
The Rules do not apply
- to all medical devices other than those mentioned in the list above
- products not intended for medical purposes listed in Annex XVI of the MDR (in short, contact lenses, products intended to be introduced into the human body by means of body modification surgery, skin fillers or of the face, high-intensity electromagnetic equipment used on the human body and equipment intended for brain stimulation which passes through the skull).
Recipients and requirements
Implantable medical devices, active implantable MDs, fixed installed MDs and MDs in general (if equipped with an integrated system for displaying instructions for use – Art. 3(1), IFUr), may be accompanied by a notice in electronic format under these conditions:
- The medical device must be intended for “professional users”;
- there must be no “reasonably foreseeable” use of the medical device outside of the healthcare sector.
On the other hand, all medical software can be marketed with the EIFU alone, whether intended for professionals or directly for patients. Thus, all the applications qualified as medical devices can be marketed with the only leaflet in electronic format. However, the conditions that justify this choice – which is already widespread in practice, although wrongly – are quite strict.
Under what conditions can EIFUs be provided?
Undoubtedly, choosing to use EIFUs makes life easier for the fabricator and saves paper and money. On the other hand, however, EU Regulation 2021/2226 stipulates that the manufacturer must comply with the following obligations:
- carry out a “risk assessment” to demonstrate that the EIFUs maintain the level of safety offered by the paper instructions for use, also updated taking into account the experience acquired in the post-marketing phase of the medical device (art. 4 (1));
- provide EIFUs in all states where the product is made available (Art. 4(2));
- have a system in place to provide the user with paper EIFUs (Article 5(3) provides that the period during which the user can request them free of charge shall be determined by the manufacturer in the “risk assessment ” referred to in the previous one);
- include information on foreseeable medical emergencies (Art. 5, (4), part 1) directly on the DM or on an accompanying leaflet;
- include the information relating to the commissioning of the device (art. 5(4), second part) directly on the MD equipped with an integrated system, or on an accompanying notice;
- ensure the correct design and operation of the EIFU and be able to provide evidence of checks and validations, if applicable (Art. 5(5))
- ensure that the display of the EIFU does not interfere with the safe use of the MD with integrated IFU display system, in particular with regard to vital functions or monitoring of vital parameters (art 5(6))
- provide information on the hardware and software used to display the EIFUs on the online catalog or on any other appropriate information medium (Art. 5(7));
- have a system in place to notify the user of the medical device of any revisions to the EIFU for safety reasons (Art. 5(8));
- keep the EIFUs for ten years from the date of the last placing on the market of the product (i.e. the last sale) and for at least two years from the expiry date of the last product manufactured , up to fifteen years for those without an expiry date and for implantable medical devices (Art. 5, (9)(10);
- make the EIFU available to the user on the manufacturer’s website in as many languages as there are states in which the MD is made available (Art. 4(11))
- have a system to notify the user who downloaded the EIFU from the website of any updates (Art. 4(12));
- make available on the website all previous versions of the EIFUs with their date of publication (Art. 4(13)).
EIFU information, access and format
Manufacturers should indicate that EIFUs are provided in electronic rather than paper form, clearly indicating this choice:
- on the DM label
- on the packaging of each product unit;
- where applicable, on commercial packaging;
- on the product itself in the case of fixed MDs installed;
- on the access point in the case of software.
The means of access and download must also be indicated: when it is not possible to place this information in one of the above positions, it can be indicated in a separate paper document provided with the DM.
The manufacturer must also indicate
- any information necessary to access the EIFU and to identify the MD (including name and, if applicable, model;
- the base UDI-DI and/or the MD UDI-DI;
- manufacturer’s contact details, such as name, address, email address, website or other online means of communication;
- the period within which the user can request the IFU in paper format free of charge;
- where and how to request the IFU in paper format.
Finally, the Regulation stipulates that EIFUs must be accessible in their entirety; they may include symbols or graphics; they contain the same information as the paper version of the IFU; and they can contain video and audio in addition to text.
Obligation to make user manuals accessible on a website
The part – always neglected – concerning websites is very interesting. The MDR already stipulates for all MDs that, when the manufacturer has a website (almost all, these days), the manufacturer is obliged to also publish the IFU in paper format on his website (Annex I point 23.1 ). Reg. 2021/2226 details a number of more specific obligations in the case of EIFU. More specifically, it stipulates that, for MDs with an integrated system and in cases where the EIFUs are supplied with the MD on a “portable electronic medium”, not only the manufacturer has the obligation to publish the EIFU online, but above all the website must comply with the following requirements (art. 7)
- the EIFU must be able to be consulted with software that is freely available and obviously free of charge;
- the site must be protected against unauthorized access or manipulation likely to compromise data security;
- interruptions and display errors on the server should be kept to a minimum;
- the website must comply with the regulations on the processing of personal data set out in EU Regulation 2016/769;
- the website’s Internet address must be stable and accessible;
- all previous versions of the EIFU with their publication date should be uploaded to the website.
Is a Notified Body (NB) required to implement EIFU?
Article 8 of the IFUR states textually: “Where applicable, compliance with the obligations provided for in Articles 4 to 7 of this Regulation shall be checked by a notified body during the procedure applicable to the conformity assessment referred to in Article 52 of Regulation (EU) 2017/745.”. Thus, when the certification process involves a NB, compliance with the EIFU framework will be verified by the NB itself as part of the MDR Article 52 assessment procedure.
IFUR does not apply to legacy medical devices
EU Regulation 2021/2226 only applies to MDR medical devices. For legacy medical devices (Art. 120 MDR), Recital 9 states that the old EU Regulation. 207/2012 continues to apply, which does not apply to software. This, from a strictly legal point of view, means that old SaMDs cannot have instructions for use in electronic format (i.e. applications must have instructions on paper).