Beschreibung
MedicalMountains fully supports the European Commission’s initiative to amend EU Regulation 2021/2226 and welcomes the possibility to comment on the draft implementing regulation within this consultation process.
The initiative marks a significant step forward, as the broad use of electronic Instructions for Use (eIFU) will improve their accessibility, searchability, and flexibility for healthcare professionals, fostering at the same time sustainability, resource conservation, climate protection, and the essential digitalization needed for the EU to maintain global competitiveness.
However, the amendment is also a major step forward in this respect, as a wide range of medical devices can now benefit from the use of eIFUs and their mass will increase exponentially. For this reason too, the practicality, clarity and efficiency of the regulation are essential if its implementation is to be successful.
With regard to the draft text, we therefore propose a more precise wording in some parts of the text in order to avoid possible misinterpretations. We also suggest reconsidering some procedures for legacy devices.
Our comments and suggestions can be found in this document.
Published in March 2025
