Digitization of Instructions for Use: the European Commission has endorsed a new Implementing Regulation on the use of electronic instructions for use (eIFUs) of medical devices

On December 14 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226^[1] (the “Implementing Regulation”) laying down rules for the application of Regulation (EU) 2017/745 (the “MDR”) of the European Parliament and of the Council relating to electronic instructions for use (the “eIFUs”) of medical devices.

The Implementing Regulation, effective as of January 4 2022, repeals and replaces Commission Regulation (EU) 207/2012, which has allowed the use of eIFUs since 2013, adapting to new MDR requirements and technological developments in the field.

However, the Commission Regulation (EU) 207/2012 continues to apply to devices already placed on the market or put into service during the transitional period set out in Article 120(3) of the MDR, i.e. until May 26 2024.

The benefits of the use of eIFUs for medical devices are obvious: E-labeling produces less paper waste and can reduce the environmental burden and the costs for the medical device industry, while maintaining or improving the level of safety by giving users access to important information when needed.

What does the Implementing Regulation establish?

The Implementing Regulation establishes the precise conditions that manufacturers have to comply with in order to provide the user with eIFUs and also certain requirements concerning contents of and manufacturers’ websites for instructions for use that are provided in electronic form, in addition to instructions for use in paper form.

According to Article 2 of the Implementing Regulation, eIFUs means “instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or made available through a software or a website”. 

Clearly, the eIFUs will also have to contain all the information considered mandatory for the drafting of the IFU of any medical device by Annex I, Chapter III, point 23.4. of the MDR.

For which medical devices can instructions for use be provided in electronic form?

According to Article 3 of the Implementing Regulation, instructions for use may be provided in electronic form, rather than in paper form, where those instructions relate to any of the following types of devices, covered by the MDR, and intended for exclusive use by professional users:

• implantable and active implantable medical devices and their associated accessories;
• fixed installed medical devices and their associated accessories;
• medical devices and their associated accessories with a built-in system visually displaying the instructions for use.

Principal key points of the Implementing Regulation

Below is a summary of some of the key points of the Implementing Regulation:

• The Implementing Regulation expands the use of eIFUs to a larger group of medical devices – in particular to all software falling within the scope of the MDR – and when it is not exclusively intended for professional users but for patients (eg. apps).

• Manufacturers must take into account two new elements when performing the required risk assessment: (i) the assessment of the eIFU’s compatibility with different devices that could be used to display the instructions and (ii) the management of different versions of the eIFU, where applicable.

• The Implementing Regulation requires, to ensure unconditional access to the eIFUs and to facilitate the communication of updates, that manufacturers make instructions for use available on their website, in the official language(s) of the Union determined by the Member State in which the device is made available to the user or patient, by indicating on the device’s label that IFUs are provided in electronic form instead of paper form.

As the Implementing Regulation requires that websites containing IFUs should fulfill the transparency requirements under the EU General Data Protection Regulation (GDPR), consent being obtained for the processing of personal data needs to be GDPR-compliant (including as it relates to the use of any non-essential cookies on the website).

[1] The Implementing Regulation is available at the following website: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2226.