Eucomed, the European Medical Technology Industry Association, welcomes the approval by the Regulatory Committee on Medical Devices of the draft Regulation on electronic instructions for use (IFUs) of medical devices. Electronic IFUs (or e-labels) have the potential to not only improve patient safety and reduce the medical technology industry’s environmental impact, but also to ensure that the correct IFUs are available at the right time in the right place, while facilitating their storage.
Integrating animation, one of the many features of e-labels, considerably reduces the risk of misinterpretation of the instructions and facilitates translation into the different EU languages. Moreover, storing, controlling and distributing e-instructions is easier than with traditional paper instructions. Additionally, they allow for reduced packaging, fitted around the device itself rather than around a paper manual which can be several times larger than the actual device.
“Electronic instructions for use offer tangible benefits for people, manufacturers and the environment and as such, we are pleased to see the e-labelling regulation being approved. We believe that this will lead to more widespread acceptance of e-instructions for use and the beneficial impact they can have on people’s lives” John Wilkinson, Eucomed’s Chief Executive, said.
To avoid any differing interpretation once the Regulation comes into effect, Eucomed trusts that the Commission will develop further guidance which puts the responsibility for deciding in which languages the electronic IFUs will be made available in the hands of manufacturers, based on their business strategy.
Next steps
The regulation will now be submitted to the Council and European Parliament who will have 3 months to exercise their right of scrutiny and evaluate whether the European Commission has exceeded its powers with this proposed Regulation.
Final publication and entry into force is expected at the beginning of 2012.
Source: Eucomed
published: October 5, 2011 in: Healthcare, Regulatory, Technology