Newly Available: Notified Body IVDR Transition Extension Letter Template
26 July 2024
EU Commission: Publishes Links to Each Notified Body’s List of Public Fees
10 August 2024Background
Current MDR eIFU Requirements
Under the MDR 2017/745, electronic Instructions for Use (eIFUs) are allowed for the following types of medical devices:
- If they are for professional use and use by other persons is not foreseeable:
- Implantable and active implantable devices,
- Fixed installed medical devices and their accessories, and
- Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use.
- For software covered by the Regulation, the instructions may be provided in electronic format by means of the software itself.
Certain conditions apply, e.g., manufacturers must provide a paper copy of the IFU upon request.
See Commission Implementing Regulation (EU) 2021/2226 for more information.
Industry’s Call to Action
In February 2024 MedTech Europe, along with 11 other organizations, asked the Medical Device Coordination Group (MDCG) to consider extending the scope of Regulation 2021/2226. The joint statement and fact sheet are available here.
Some of arguments presented were:
“…data collection surveys…from which clear messages emerged regarding the preference for an electronic format IFU:
- Over 88% of healthcare professionals would prefer to have the electronic IFU;
- Over 90% of the hospital administrative staff/ hospital pharmacists would prefer to have eIFU for medical devices;
“…the numerous and compelling advantages of eIFU over paper-based instructions:
- Increased efficiency in MDR implementation: electronic formats facilitate the inclusion of multiple languages and therefore contribute to reducing the risk of shortages of medical devices and improving the overall availability of these devices, especially in a multilingual context like the European Union.
- Cost efficiency: Over time, the implementation of eIFU can lead to cost savings for both manufacturers and healthcare institutions, as the need for printing, distribution, storage and waste management of paper IFU is significantly reduced.
- Environmentally sustainable: The transition to eIFU aligns with broader efforts to reduce paper usage, contributing to environmental sustainability and supporting the EU Green Deal.”
Further, in February 2024 a request was posed to the EU Commission, to expand the scope of medical devices eligible for eIFUs.
The Commission’s response, published April 2024, was that eIFUs would be considered as part of the Commission’s overall evaluation of the MDR. Particularly since the evaluation will pay special attention to the “costs and administrative burden stemming from the implementation of legislation, especially for small and medium-sized enterprises”.
The Update
The EU Commission initiated a new survey on eIFUs. It is available here.
The purpose is to collect feedback on allowing the use of eIFUs for all professional use medical devices. Note that the survey is targeted to “…healthcare professionals and or other persons working in or employed by a healthcare institution in the European Union…”, and not to industry in general.
It starts today (August 1) and closes on Friday, 11 October 2024.
