MedTech Europe response to electronic Instructions For Use (eIFU) regulation revision

MedTech Europe warmly welcomes the European Commission’s proposal for the update of the EU Regulation 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices.

This is a move in the right direction as electronic instructions for use (eIFU) will improve accessibility, searchability and adaptability for professional users of medical devices. The possibility to provide eIFU for all professional use medical devices will also greatly contribute to reduction of paper waste and help manufacturers streamline their process and supply their devices faster. The user will always have the most up-to-date version of the IFU.

Looking towards the future, in the fast-changing digitalisation landscape, a more eco-friendly, paper-free, and efficient healthcare environment is imperative. Further digitalisation is crucial for increasing Europe’s competitiveness, streamlining processes and reducing administrative burden of both EU Regulations for Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

For the medical device sector, further digitalisation initiatives need to be envisaged, such as eIFU for lay users (particularly where the lay user is trained by a professional). For the IVD sector, MedTech Europe calls for expanding eIFU to all professional use IVDs, including devices intended for near-patient testing.

We would like to urge a start of such discussions in the Medical Devices Coordination Group (MDCG) as soon as possible; in line with the overall broader ambition around EU goals of competitiveness, simplification, digital transformation, and sustainability.

Read our full response with concrete suggestions for the current revision below.