The Commission of the European Union (EU) has also published requirements for providing medical device instructions in electronic form under the scope of the EU’s Medical Device Regulation (EU 2017/745, or the MDD).
Commission Implementing Regulation (EU) 2021/2226 was published in mid-December 2021 and represents a detailed, article-by-article supplement to the MDD on the conditions under which instructions for the use of medical devices may be provided in electronic form. The Regulation will help expand the use of non-paper-based instructions that can contribute to reduced environmental impact while also lowering manufacturers’ costs.
At the same time, however, the Regulation clearly notes that providing instructions on the use of medical devices in electronic form “should be limited to certain medical devices and accessories intended to be used under specific conditions,” and that “for reasons of safety and efficiency, users should always have the possibility to obtain those instructions for use in paper form upon request.”
