On 14 December 2021, the EU Commission published in the Official Journal of the EU the Implementing Regulation (EU) 2021/2226 which lays down detailed rules for the application of Regulation (EU) 2017/745 (Medical Devices Regulation) as regards electronic instructions for use for medical devices (MD).
The EU Commission came to the conclusion that for some medical devices, the provision of instructions for use in electronic form instead of in paper form can be beneficial. It can reduce the environmental burden and reduce costs for the medical device industry while maintaining or improving the level of safety.
That’s why it published the Implementing Regulation (EU) 2021/2226 which will enter into force on 4 January 2022 and repeal the previous Regulation (EU) 207/2012 (which applied to medical devices complying with older Directives 93/42/EEC and 90/385/EEC). However, legacy devices (older devices which comply with historical regulatory requirements) must continue to comply with Regulation (EU) 207/2012 as long as they continue to be placed on the market in accordance with the above-mentioned Directives.
The new Implementing Regulation clarifies under which conditions the instructions for use (required by the Medical Devices Directive) may be provided in electronic format instead of in a paper form. It also lists the requirements for the content and website presentation of the electronic instructions.
The term ‘instructions for use in electronic form’ is defined in the Implementing Regulation as 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.
Basically, electronic instructions are allowed for certain categories of medical devices and their accessories, provided that they are exclusively used by professionals and their use by other persons cannot reasonably be foreseen. These are e.g.:
- Implantable and active implantable medical devices
- Fixed installed medical devices
- Medical devices that have an integrated system displaying instructions for use.
- Software may also directly contain instructions for use in its own interface.
On the other hand, non-medical devices mentioned in Annex XVI of the Medical Devices Regulation are not affected by the provisions of the Implementing Regulation (EU) 2021/2226.
Several legal requirements apply specifically to manufacturers who choose to provide their leaflet in electronic format. Especially, they are obliged to:
- Assess the risks associated with this type of supply and update this assessment after the MD marketing
- Be able to provide the leaflet in paper format on request, at no additional cost to the user and within a timeframe set out in the risk assessment, no later than seven days after receipt of the user’s request, or on delivery of the device if the request was made at the time of order
- Ensure that users are informed of updates and corrective actions to the electronic leaflet
- Indicate on the label of the MD or on the MD itself that the package insert is provided in electronic format
- Provide information on how to access the package insert
- Comply with the requirements for the website displaying the leaflet.
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