Electronic instructions for use for medical devices

As an international consulting company, we discussed the topic of electronic instructions for use (eIFU) in detail with many of our clients. Therefore, we would like to introduce our comments to this topic as well. Article 2: •The definition of fixed installed medical devices could be a more detailed to allow a clearer distinction between included and not included devices.

As a leading supplier in offset printing technologies we see "barrier free" accessible and safe product information for all patients as a must to ensure equal health protection for all ages. Printed information ensures that there are no access problems for all groups of users.

The European Association of Hospital Pharmacists (EAHP) welcomes the European Commission’s proposal for the Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices.

COCIR appreciates the additional opportunity to provide industry feedback to the draft Implementing Regulation on electronic instructions for use (IfU) under the Medical Device Regulation. In general, the availability of electronic IfU is wider than providing one hardcopy. Commonly used technologies provide means for full-text search which has a clear benefit for the usability of the Instructions for Use.

I would state my objection to the proposed change in regulations to ePI. In my perspective there are a lot of gaps and missed opportunities to communicate the crucial information needed by patients, caregivers and HCPs.

We acknowledge the proposed update to Regulation 207/2012 relating to electronic instructions for use for medical devices, and recognize the value in the provision of such information in electronic form for medical professionals and users of MED-EL hearing implants / devices. In preparation for this we request that the following be considered: 1.

The German Dental Industry Association (VDDI) represents more than 200 manufacturers of dental products used by professional users in dental practices and dental laboratories. From the VDDI's point of view, the submitted draft on the electronic instructions for use of medical devices is inadequate because it does not address any significant improvements compared to the existing eIFU rules adopted under Commission…

We are very concerned about the way in which the narrative promotes digital media at all levels by identifying the use of paper with a significant environmental impact, without taking into account the contribution of the forestry industry to the sustainability of Europe’s forests and the protection of biodiversity, or the commitment to the circular economy of the paper industry, while minimising the environmental…

Filed in Croatian · English published by the European Commission

MedicalMountains GmbH welcomes the extension that MDR software is included in the draft, however encourages the European Commission to widen the scope making e-IFUs available for all medical products that are used by professionals.

EUROMCONTACT is the association representing the contact lens and lens care products manufacturers in the European Union. We represent more than 90% of the soft contact lens and 80% of the contact lens care products, and more than 50% of the rigid contact lenses in the European market.

As a responsible packaging producer for healthcare, with factories located in western of Europe, we do share the importance of ALL patient safety. • The use of printed information gives a granted access for ALL patients at ALL crucial details for an appropriated and safe medication or medical devices utilization.

We think it is still very important to provide patients with paper information. It gives the patient the opportunity to have the information available at any time and independently of a digital technology. Electronic product information safety performance is not guranteed and therefore papier information leaflets are the only truly reliable and therefore safe means of the distribution of information with medical…

SPECTARIS is the German Industry Association for Optics, Photonics, Analytical and Medical Technology based in Berlin. The association represents 400 predominantly medium-sized German companies. This initiative aims to renew the existing eIFU rules established under Commission Regulation (EU) 207/2012 in order to “reduce the environmental burden and reduce costs for the medical device industry while maintaining or…

As a provider to the healthcare industry for packaging, inserts and labels we are against the EU proposal to switch to digital PIL's. Especially the risk involved of not reading important safety considerations needs to be evaluated. Where the paper PIL is directly in your hands when opening the product, reading the digital version depends on the discipline and action of the user.

As manager of an PMI company which produces pharmaceutical leaflets in Europe (production site in Belgium), I can only be totally opposed to this initiative. Reliable, complete, validated and available information with the medicinal product or medical device is essential for patient safety and information.

Filed in French · English published by the European Commission

Thank you for giving me this opportunity. The risk assessment required by Article 4 is carried out according to the MDR harmonised standard EN ISO 14971:2019, which allows for multiple media types in the ‘accompanying documentation’ including IFUs for all medical devices.

1. Research has proven that people desire printed information for technically complicated communications 2. Paper information leaflets are the only truly reliable and therefore safe means of the distribution of information with medical devices 3. Some older people are rejecting digital technology 4. Electronic product information safety performance is not guaranteed 5.

We welcome the initiative to revise Regulation 207/2012 in order to align it with the MDR (EU) 2017/745. We appreciate the opening of a public consultation on this matter. Our comment concerns the a priori exclusion of the devices covered by Annex XVI (see art 1) Indeed, many devices of Annex XVI fall within the application criteria as described in article 3 of the draft regulation.

Intergraf represents 21 national printing federations in 19 countries in Europe. The printing industry provides jobs to 640,000 Europeans active in over 110,000 companies and generates a turnover of approximately € 82 billion. The industry throughout Europe consists mainly of small enterprises, as 90% of them employ fewer than 20 persons.

Paper PIL´s can, where appropriate, be replaced with electronic solutions. However, there are several risks with this development that could effect patient safety. This risk should therefore be very highly evaluated. The risk of making mistakes in connection with medicine consumption, when digital connections are failing, can easily be avoided with the paper PIL.

Dear Sir or Madam, it would be nice to clarify within 207/2012: - if IFUs are provided with the product box in English but other EU countries have their own language requirements and the manufacturer provides for these countries an online IFU, would this be a case of providing an online IFU instead of a written one and should all the requirements of 207/2012 be fulfilled? Best Wishes, [name removed]

Paper information leaflets are the only truly reliable and therefore safe means of the distribution of information with medical devices – the risk of hardware or software failure, that the Commission’s document alludes to, are entirely negated with paper information leaflets Common templates can be used with paper information leaflets to facilitate cost control and increase patient comprehension Environmental claims…

Certainly, paper instructions should be replaced by online manuals in consequence of several advantages: - current at all times - available at all times - no need for extremly small letters as in case of many multi-language paper instructions - no need for abandonment of actualization as in case of many paper instructions

BVMed welcomes the extension that MDR software is included in the draft. However, we point out our previous call for a scope extension to all professional use medical devices. Specifically accesses to non-implantable/professional medical devices used in the same procedures and by the same users, medical devices and accessories for use in connection with a device with a built-in system displaying the IFU and systems…

Filed in German · English published by the European Commission

Hello, making something digital that is essential for patients’ health without being sure that the patient has an intangible means of consulting it is impardonable and irresponsible on the part of the European Commission and the pharmaceutical laboratories that will apply it. nobody can guarantee full network coverage, let alone in hospitals that recommend switching off mobile phones.

Filed in French · English published by the European Commission

We agree with the proposal to update Regulation 207/2012 regarding electronic instructions for use for medical devices in order to reflect the change in society to desire information in an electronic form. We would like the following points to be taken into account: 1) Consider expanding the scope of the Regulation for all users (not just professional users).

On behalf of UNI Europa Graphical & Packaging: We are very concerned about the way in which the narrative promoting digital media has been introduced at all levels by identifying the use of paper with a higher environmental impact, without taking into account the contribution of forest-based industries to the sustainability of European forests and the protection of biodiversity, or the commitment to the circular…

The package insert is the main source of information on medical devices, being consulted by both health professionals and users. It is in itself difficult to interpret for the general population due to the complexity of the vocabulary used, and it is also frequently associated with difficulty in reading, due to the very small font size.

1. Article 2: Suggest adding a definition for ‘built-in system’ Article 3 (1) (c). 2. Article 3 (1): - ‘Manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices’. Is there a distinction between complete or partial IFU in electronic form?

As a responsible manufacturer of sustainable healthcare packaging, we share the common goal of advancing patient safety and see the continued use of printed medical information as a key means to achieve that. Our concerns with implementing regulations to replace paper information leafets with online manuals (ePI) span accessibility, cognition and ultimately the safety of patients.

Feedback to the Medical devices – online manuals replacing paper instructions Commission Implementing Regulation Ares(2021)2803762 This document outlines the views of Essentra Packaging, a company that provides secondary packaging to the healthcare industry; focused on enhancing patient safety, improving adherence through effective packaging design, and proactively implementing strategies to minimise the…

Article 5 (12) Instructions for use should not in principle be changed after the conformity assessment procedure has been completed or only as a result of corrective actions. Therefore, “or” should be replaced by “caused by”.

Filed in German · English published by the European Commission

We welcome the initiative to revise Regulation 207/2012 regarding electronic instructions for use for medical devices in order to align better with the MDR 2017/745 and to reflect current trends in terms of digitisation. We would like to also point out that providing instructions for use in electronic form instead of in paper form can help reduce the environmental burden.

Dear Commision, Thank you very much for the draft and for allowing comments by economic operators. Especially Article 2 (3) is a great improvement. We would like to give a few suggestions in the following of which we believe alle operators would benefit.

Another remark to my comment of May 12, 2021: In MDCG 2018-1 Rev. 4 of April 2021 the definition of the Basic UDI-DI quotes: "It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item". This quote is also repeated on the newly installed UDI Helpdesk.

Welcomes the fact that this will allow the manuals to be kept up to date, provided that the manufacturer/supplier stores them in a fixed digital place and is easily accessible to all parties (distributors and healthcare providers), as well as proper version management, so that customers can always have the latest version and quickly see the differences with older versions.

Filed in Dutch · English published by the European Commission

EIGA is a non-profit European Association representing the majority of medicinal gases and medical device gases manufacturers. Medical device gases, such as carbon dioxide and liquid nitrogen, are delivered in container closure systems such as high pressure gas cylinders and vacuum insulated cryogenic vessels, used only by healthcare professionals in hospitals and clinics.

This proposal is of a great importance for the industry and welcome the extension of the electronic format to software covered by the MDR. It would be important to extend the use of electronic IFU format to Class I devices with low risks in Article 3. This could be documented as part of the risk assessment in the technical file of the device as stated in Article 4.

In article 6 (3) the Basic UDI-DI should be removed. It does not facilitate the search for the correct eIFU. On all labels the product must anyway be sufficiently identifiable, including name and model of the product and manufacturer's name, address and website. This should serve to find the corresponding eIFU.

We as a SaMD manufacturer strongly recommend to revise Art. 3 (3). The limitation of not needing a paper-based IFU for professional users should be extended to laypeople/patient user. Medical apps are designed to be used time- and place- independent. Every extra effort e.g. reading a PAPER IFU to use the application poses a unnecessary barrier for patients.

As the Basic UDI-DI is not supposed to appear on any trade item, I think it would be more appropriate to exclude Basic UDI-DI from the information on how to access the IFU in electronic form (Article 6(3)(b)). Also, Article 7.2(d) from Regulation (EU) No 207/2012 can be kept in this new regulation since the website should mention in which Union languages the manufacturer provides eIFU on the website.

- Preamble item (6): eIFU provided in Addition to paper IFU The wording is unclear due to complicated structure of sentence. Please improve and possibly align with Art. 9. - Art. 7 (1): For SW it is not required to have the IFU available on a Website. Please consider adding SW, as there is no reason to treat SW differently.

Dear EU Commission I recommend maintaining the wording of EU Reg 207/2012 Article 6 Section 3 (b) (a unique reference, giving direct access.....) in the new regulation. Electronic IFU must be provided simple and unambiguously. Without a unique reference (REF, UDI, QR code, etc.) medical device users are left alone with searching and selecting eIFUs listed somewhere on companies marketing websites.