Beschreibung
The EU MDR increases the requirements for instructions for use. However, the EU MDR does not state whether they may be available in electronic form. These requirements are set out in Regulation (EU) 207/2012 (eIFU for short). In fact electronic instructions for use significantly improve user and patient safety.
Regulation (EU) 207/2012 is currently limited to a small number of medical devices. For example, reusable surgical instruments in risk class Ir, which are intended solely for use by specialists, are excluded. The regulation urgently needs to be modernised if the EU MDR is to be implemented effectively. The most important facts that make the revision process necessary include
- Environmental protection
- Ensuring up-to-date information to end users
- Improved availability rates
- Improved suitability for use
You can download the position paper in German and English free of charge.
Published July 2020
