Electronic instructions for use of medical devices: here’s what you need to know

Abstract

The article analyzes the new rules introduced by Reg. 2022/2226 on instructions supplied to medical devices in electronic form.

The Regulation establishes for which types of devices information may be issued, Annex I p. 23 only in electronic format, including medical programs.

Thus, the new discipline is especially relevant for manufacturers of medical applications, which now have clear rules for the release of E-Ifu for applications.

2022 opens with the new (long-awaited) EU Regulation 2021/2226 on Electronic Instructions for Use (IFU) for medical devices. The regulation, which came into force on January 4, 2022, replaces the previous reg. EU. no. 207/2012 and aims to adapt the rules of electronic IFU to the new EU Regulation 2017/745 (MDR), to the technological developments of recent years and to the principles of the green economy. In particular, EU Regulation 2021/2226 has an impact on the field of medical software: it regulates for the first time the rules of electronic instructions for the use of “Software as Medical Devices” (SaMD), such as applications.

What is said in the Regulations

EU Regulation 2021/2226 sets out the exact conditions that a manufacturer must meet in order to provide an IFU user electronically, as well as certain requirements for the content and presentation of IFUs on manufacturers’ websites. According to Article 2 of the Regulation, IFU in electronic form (eIFU) means “Instructions for use that can be displayed electronically on the device, supplied by the manufacturer, on portable electronic media with the device or available through software or website”. Obviously, the eIFU should also contain all the information required as mandatory for the preparation of the IFU for any medical device in accordance with Annex I, Chapter III, paragraph 23.4. MDR.

To which medical devices does the IFU apply?

Article 3 contains a closed list of types of medical devices and related accessories to which the Regulation may apply. These are:

  • Implanted Medical Devices (MD) as defined in Article 2 (5) of the MDR;
  • Active implanted MDR as defined in Article 2 (4) and (5), MDR;
  • Fixed established MD, defined in Article 2 of the Regulations as “devices and accessories intended to be installed, secured or otherwise protected in a specific place in a medical establishment in such a way that they cannot be moved or removed without the use of tools or equipment and which are not intended for use in a mobile healthcare facility »;
  • MD, equipped with an integrated IFU display system
  • MDR-regulated software.

Prohibition of application

The rules do not apply to:

  • any other doctors of medicine other than those listed above
  • products not intended for medical use listed in Annex XVI to the MDR (summary: contact lenses, products intended for human administration by body modification operations, products for filling the skin or face, high-intensity electromagnetic equipment used on the human body and equipment designed to stimulate the brain that passes through the skull).

If the intended recipients are professional users or also patients

Implanted MD, active implanted MD, stationary installed MD and MD in general (if equipped with an integrated system for displaying instructions for use – Article 3 (1), IFUR) may be accompanied by instructions in electronic format under the following conditions:

  • MD should be designed for “professional users”;
  • it doesn’t have to be “reasonably predictable”That MD will be used outside the professional channel.

On the contrary, all medical software can only be sold with eIFU, whether it is intended for professionals or directly for patients. Therefore, all programs qualified as medical devices can be placed on the market with instructions only in electronic format. However, the conditions that legitimize this choice, which is already widespread in practice, although incorrect, are quite harsh.

Under what conditions can eIFU be provided?

There is no doubt that choosing an eIFU makes a manufacturer’s life easier and saves paper and money. On the other hand, EU Regulation 2021/2226 stipulates that the manufacturer must fulfill the following obligations:

  • perform “risk assessment”To demonstrate that eIFUs support the level of security provided by paper IFUs; the assessment should also be updated in the light of the experience gained in the post-marketing phase of the MD (Article 4 (1));
  • ensure eIFU in all countries where the product is available (Article 4 (2));
  • have a system to also provide the user with paper IFUs (Article 5 (3) states that the period during which the user may request them free of charge must be specified by the manufacturer in the “risk assessment”Mentioned in the previous paragraph);
  • provide information on anticipated medical emergencies directly to the doctor or in the accompanying leaflet (Article 5 (4), first part);
  • also provide information on the commissioning of the device directly on the MD, equipped with an integrated system, or in the accompanying tab (Article 5 (4), second part);
  • ensure the proper design and functionality of the eIFU and be able, where necessary, to provide evidence of verifications and confirmations (Article 5 (5));
  • ensure that the eIFU mapping does not interfere with the safe use of the MD with an integrated IFU mapping system, especially with regard to life support functions or the monitoring of vital indicators (Article 5 (6));
  • include information on the hardware and software used to display the eIFU in a web directory or other relevant medium (Article 5 (7));
  • have a system to inform the MD user of any changes made to the eIFU for security reasons (Article 5 (8));
  • keep the eIFU for ten years from the date on which the product was last placed on the market (ie last sale) and for at least two years from the expiry date of the last manufactured product, increasing to fifteen years for products without expiration date and for implanted physicians (Article 5 (9-10));
  • make the eIFU available to the user on the manufacturer’s website in the language of each country where the MD is available (Article 4 (11));
  • have a system for informing the user who downloaded the eIFU from the website about any updates (Article 4 (12));
  • make available on the website all previous versions of the eIFU together with the date of their publication (Article 4 (13)).

Information, access and eIFU form

Manufacturers should also indicate that IFUs are shipped electronically rather than on paper, clearly indicating this choice:

  • on the MD label;
  • on the packaging of each unit of product;
  • if necessary on commercial packaging;
  • on the product itself in the case of fixed installed MD;
  • at the access point in the case of software.

The instructions for access and download should also be indicated: if it is not possible to provide this information in one of the above points, it may be indicated in a separate paper document that comes with the MD.

Other indications

The manufacturer must also indicate:

  • any information needed to consult the eIFU and to identify the MD (including name and, if applicable, model);
  • basic UDI-DI and / or UDI-DI MD;
  • contact details of the manufacturer, such as name, address, email address or other means of Internet communication and website;
  • the period during which the user can request IFU free of charge in paper format;
  • where and how to request IFU in paper format.

Finally, the Regulation stipulates that eIFUs must be available in full; they may include symbols or graphics; they contain the same information as the IFU in paper format; they can contain video and audio in addition to text.

Duty to make IFU available on the website

The part about websites that you don’t always pay attention to is very interesting. The MDR already establishes for all MDs that if a manufacturer has a website (almost all of them at this stage), the manufacturer is required to publish its IFU (created in paper format) also on the website (Annex I, paragraph 23.1). . Reg. EU 2021/2226 further details a number of more specific commitments in the case of the eIFU. More specifically, it is found that for MDs with an integrated system and in cases where eIFUs come with MDs on “portable electronic media», Not only the manufacturer is obliged to publish, but, above all, the site must meet the following profiles (Article 7):

  • it should be possible to consult the eIFU with software that is freely available and, of course, free;
  • the site must be protected from unauthorized access or interference that may compromise data security;
  • server downtime and display errors should be minimized;
  • the site must comply with the legislation on personal data processing set out in EU Regulation 2016/769;
  • The Internet address of the website must be permanent and accessible;
  • any previous versions of the eIFU with the date of their publication must be downloaded from the website.

Is an authorized body needed to implement the eIFU?

Article 8 of the IFUR states: “Where necessary, compliance with the obligations set out in Articles 4-7 of this Regulation shall be verified by the competent authority (NB) during the applicable conformity assessment procedure referred to in Article 52 of Regulation (EU) 2017/745.” Therefore, if the NB is involved in the certification process, compliance with the eIFU regulations will be verified by the NB itself during the assessment process under Article 52 of the MDR.

IFUR does not apply to obsolete medical doctors

EU Regulation 2021/2226 applies only to MDs in accordance with MDRs. For obsolete MD (Article 120 MDR) Article 9 states that the previous reg. EU. 207/2012 continues to operate, which does not include application to software. From a strictly legal point of view, this means that obsolete SaMDs may not have instructions for use in electronic format (i.e. applications must have paper instructions).

.

Leave a Comment