On 14 December 2021, the European Commission adopted Implementing Regulation (EU) 2021/2226 laying down the rules for the provision of electronic instructions for use for devices covered by Regulation (EU) 2017/745 (the "Medical Devices Regulation"- “MDR”).
This Regulation repeals the former Regulation (EU) 207/2012, which was in place for devices subject to the Council Directives 90/385/EEC and 93/42/EEC (together the "Medical Devices Directives"). The former Regulation will, however, remain applicable to legacy devices (i.e. devices certified under the Medical Devices Directives and placed on the market or put into service until 26 May 2024).
Scope
The possibility to provide electronic instructions for use is limited to the medical devices below:
(a) implantable and active implantable medical devices and their accessories covered by the MDR;
(b) fixed installed medical devices and their accessories covered by the MDR;
(c) medical devices and their accessories covered by the MDR and fitted with a built-in system visually displaying the instructions for use;
(d) software covered by the MDR.
The new Regulation does not cover products without an intended medical purpose (listed in Annex XVI to the MDR).
For the devices referred to in points (a) to (c), manufacturers may provide electronic instructions for use only if (i) the devices are intended exclusively for professional use and (ii) the use by persons, other than professionals, is not reasonably foreseeable.
For software covered by the MDR, as referred to in point (d), these conditions do not apply. This is an important change compared to the old Regulation (EU) 207/2012, which required also software to be intended exclusively for professional use for the provision of electronic instructions to be permissible.
In respect of software, manufacturers may provide instructions for use in electronic form instead of in paper form by means of the software itself.
Conditions
Documented risk assessment
Manufacturers of devices subject to this new Regulation which provide electronic instructions for use must carry out a documented risk assessment discussing several elements, including:
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knowledge and experience of the intended users regarding (i) the use of the device and user needs and (ii) the hardware and software needed to display the electronic instructions for use;
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access of the user to the electronic resources needed at the time of use.
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assessment of the website’s compatibility displaying the electronic instructions for use with different devices that could be used to display those instructions;
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management of different versions of the instructions for use, where applicable
The purpose of this assessment is to demonstrate that the provision of electronic instructions for use maintains or improves the level of safety compared to the provision of paper instructions for use.
Manufacturers are required to update this risk assessment in light of post-marketing experience.
Information communicated to users
Manufacturers must clearly indicate on the label that the instructions for use of the device are supplied in electronic form instead of in paper form. In the case of software, that information must be provided at the location from where access to the software is granted.
In addition, manufacturers must inform the users of how to access the electronic instructions for use. The information on how to access the electronic instructions for use must include:
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the Basic UDI-DI and/or the UDI-DI of the device and any additional information allowing the identification of the device (e.g. the name and model, if applicable);
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relevant manufacturer contact details e.g. manufacturer’s name, address, email address or other means of online communication and website.
Next steps
Regulation (EU) 2021/2226 came into effect on 4 January 2022.
Our team regularly advises clients on the requirements for instruction for use of medical devices and labelling requirements. Do not hesitate to reach out for more information.
Authored by Fabien Roy, Gregoire Paquet, and Nikoleta Kyriazopoulou.
