EC proposed amending regulation on electronic IFU for Medical Devices

In the EU, the general rule is that Medical Devices (MD) must be supplied with paper Instructions for Use (IFU). There are, currently, four (4) exceptions to this rule which permit the supply of electronic IFU (e-IFU) instead of paper IFU.

Following repeated calls from MedTech Europe and industry stakeholders , the European Commission (EC) is proposing to modify three of the exceptions. If adopted, the proposal would permit manufacturers to supply e-IFU instead of paper IFU, for all MD, intended for exclusive use by healthcare professionals (HCP).

The EC has published a draft Implementing Regulation to obtain feedback

The European Commission has now published its draft Implementing Regulation, to obtain feedback on the draft from stakeholders. Stakeholders may provide feedback until 21 March 2025.

After the feedback period, if no significant changes are made, the EC plans to adopt the amendment in the second quarter of 2025.

Prior to publishing the draft, the European Commission had conducted a survey which sought input from stakeholders. The draft provides that the results of the survey show a clear preference, among healthcare professionals, for receiving IFU in electronic form rather than in paper form.

The draft Implementing Regulation mainly concerns MD for HCP

Section 23.1 (f) of Chapter III of Annex I to the MDR provides that e-IFU may be supplied instead, of paper IFU, on the conditions provided by Commission Regulation 207/2012. This Regulation has in the meantime, been repealed and replaced by Implementing Regulation 2021/2226. The draft proposal would amend this Implementing Regulation.

Article 3 (1) of Implementing Regulation 2021/2226 currently provides that manufacturers, may provide e-IFU instead of paper IFU, for:

1. Implantable and active MD;
2. Fixed installed MD;
3. MD fitted with a built-in system visually displaying the IFU.

The draft proposes to replace Article 3 (1) in its entirety. If adopted, Article 3 (1) would instead provide that manufacturers may supply e-IFU, instead of paper IFU, for all MD intended for professional use.

For completeness, the proposal would not change any other provisions of Implementing Regulation 2021/2226. Among others, manufacturers would still need to conduct a documented risk assessment to supply e-IFU instead of paper IFU. This risk assessment will have to demonstrate that providing e-IFU maintains or improves the level of safety, compared to paper IFU.

Also for completeness, medical devices supplied on the basis of the MDR’s transitional provisions, will not benefit from the proposed draft. Such MD were subject to Commission Regulation 207/2012, the predecessor of Implementing Regulation 2021/2226. They are to remain subject to this predecessor.

All e-IFU must be made available at a URL and registered in EUDAMED in the future

The draft would provide for another amendment to Implementing Regulation 2021/2226. Implementing Regulation 2021/2226 also governs e-IFU for MD in general.

The draft would introduce an Article requiring all e-IFU, including those made available on top of paper IFU, to be published at a consistent URL (web address). Manufacturers are to register the URL in the EUDAMED UDI (Unique Device Identification) module, as soon as the use of the module becomes obligatory.

Should paper IFU become the exception?

The expansion may be great news for all stakeholders. e-IFU Have several advantages. These include among others, easier storage, access and version management increasing access to the most current information, availability in multiple languages.

E-IFU can also contribute to a significant reduction of waste. This reduction goes further than the paper, as paper IFU increase the shipping weight and must also be disposed of.

From a legal perspective, actions such Field Safety Corrective Actions and recalls related to potential safety aspects and/or IP-infringements are far faster and easier to correct in e-IFU than paper IFU.

Nevertheless, some stakeholders may consider that the draft does not go far enough. For example, the draft does not cover Annex XVI MDR devices.

Further, from a risk assessment perspective, e-IFU and paper IFU will never really have the same, higher or lower risk profile. e-IFU are better for some risks and paper IFU are better for others. As such, the recipient(s) may be best placed to consider whether they need paper IFU. Thus, reversing the general rule may be the more sustainable approach long term.

The development of EU legislation is driven by stakeholder feedback. All stakeholders may provide feedback on the draft until 21 March 2025 here.