eIFU for medical devices (Nov. 2023)

When implementing regulation (EU) 2021/2226 laying down detailed rules for the implementation of Regulation (EU) 2017/745 (MDR) as regards (electronic instructions for use) eIFUs for medical devices was published in December 2021, disillusionment spread throughout the German medical technology industry. The revision of the regulation had been associated with the hope of giving the use of eIFUs more scope – making them the standard in the professional environment and only issuing a printed version on request. Only in the case of software in accordance with the MDR has the previously valid regulation been improved.

MedicalMountains and SPECTARIS have been working intensively on the topic of eIFU for a long time and, in this joint position statement, are once again calling for a legal basis that enables the provision of electronic instructions for use for professional users for all medical devices. The reasons for this are:

  • data proves: eIFUs are wanted by healthcare professionals and medical device manufacturers
  • eIFUs keep information up to date in real time
  • eIFUs are better available
  • eIFUs are more user-friendly
  • eIFUs increase the safety of medical devices and patient protection
  • eIFUs contribute to successful MDR implementation
  • eIFUs are required for global competitivenes
  • eIFUs contribute to resource and climate protection

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