The European Commission published on December 14 in the Official Journal of the EU the Implementing Regulation (EU) 2021/2226 laying down detailed rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use for medical devices (MD).

This Regulation will enter into force on January 4, 2022, when it will repeal and replace Regulation (EU) 207/2012 which applied to MD complying with Directives 93/42/EEC and 90/385/EEC. However, it should be noted that legacy devices, as long as they continue to be placed on the market in accordance with the above-mentioned Directives, must continue to comply with Regulation (EU) 207/2012.

 This Implementing Regulation clarifies under which conditions the instructions for use (required by EGSP 23.4 of Regulation (EU) 2017/745) may be provided in electronic format rather than on paper. It also lists the requirements for the content and website presentation of the electronic instructions.

 As a reminder, and this has not changed, electronic instructions are reserved for certain categories of DMs and their accessories, provided that they are exclusively used by professionals and their use by other persons cannot reasonably be foreseen. These are :

  • Implantable and active implantable medical devices
  • Fixed installed MD
  • MD 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 referred to in Annex XVI of Regulation (EU) 2017/745 are not affected by the provisions of this implementing regulation.

 There are a number of requirements that apply specifically to manufacturers who choose to provide their leaflet in electronic format, particularly they must :

  • 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.

 The requirements set out in the previous regulation, regulation (EU) 207/2012, have been broadly retained in this new implementing regulation. Nexialist offers you a summary of the changes made:

  • Websites are subject to the requirements of Regulation (EU) 2016/679 on data protection and no longer to those of Directive 95/46/EC, which was repealed by the latter;
  • Whereas the previous regulation reserved electronic instructions for stand-alone software, it is clarified in this regulation that any software covered by Regulation 2017/745 is affected by this provision, i.e. software that is a device in itself (stand-alone) but also software incorporated in a MD ;
  • The risk assessment specific to electronic instructions has also been expanded with two new points : it must now include an assessment of the compatibility of the website presenting the instructions with different devices that may be used to display these instructions, and the management of different versions of these instructions ;
  • A new obligation for manufacturers has been added, requiring them to put in place effective systems and procedures to ensure that users are informed of any updates or corrective actions to the electronic instructions.

Finally, it should be noted that the new requirements of Regulation (EU) 2017/745 have been taken into account in the drafting of this new Implementing Regulation, particularly in terms of UDIs, language and retention period of instructions.