Companies in Germany could save around 500 tons of paper for user manuals each year if they could switch completely to electronic versions. According to an industry survey conducted by MedicalMountains and SPECTARIS, more than half of the companies in the medical technology sector have identified a desire among their customers for electronic instructions for use.
Medical technology already has the "Commission Implementing Regulation (EU) 2021/2226 of December 14th 2021 laying down detailed rules for the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use for medical devices." However, this Regulation does not apply to the devices listed in Annex XVI of Regulation (EU) 2017/745.
The exclusive use of digital instructions for use for medical devices is limited to a few product groups and is subject to conditions. Conversely, this means that the majority of medical devices are denied purely digital instructions for use. 43 percent of the companies participating in the survey provide digital instructions for use for the EU market, around two-thirds of which supplement the paper version - this leaves a proportion of only around 18 percent of all companies that can focus entirely on the digital version. The existing legal framework is cited as the main obstacle. Its expansion is considered desirable and sensible by 76 percent of the companies.
The common appeal is therefore to expand the existing legal framework in the interests of product safety – but also sustainability.
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