Tuttlingen – More than half of the medtech companies are aware of the explicit customer request for eIFUs, but only a fraction are exclusively allowed to provide them: This is the result of the current industry survey by MedicalMountains GmbH and SPECTARIS. The common appeal is therefore to expand the existing legal framework in terms of product safety, but also sustainability.
The EU regulations 2021/226 and 2012/207 continue to impose a tight corset. The sole 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 a pure eIFU is not available for the majority of medical devices. This is reflected in the current survey. 43 percent of the companies that took part in the survey make eIFUs available for the EU market, around two-thirds of them in addition to the paper version – the equivalent of only around 18 percent of all companies that can fully concentrate on the digital version. The existing legal framework is cited as the main obstacle. 76 percent of the companies consider its expansion to be desirable and sensible.
There are many arguments in favor of an expansion: Around 53 percent of the manufacturers have an explicit customer request for eIFUs. The digital instructions for use are available quickly and up-to-date in the right place, can be searched, archived and found more easily and can be flexibly provided with additional information - points that apply both inside and outside the EU. However, the top answer is “environmental considerations”. According to feedback from the industry, a complete conversion to digital user manuals could save around 500 tons of paper per year and company in Germany: an average of 482 tons for documents for professional use and an average of 522 tons for all products.
The survey results bring several anachronisms to light. "You can't push digitization and demand sustainability, but at the same time put the brakes on the operating instructions like this," emphasizes Julia Steckeler, Managing Director of MedicalMountains GmbH, and calls for a paradigm shift: "The eIFU should be the rule in the future and the printed version should be an addition at the customer's request." This did not result in any loss of safety, on the contrary. "The use of eIFUs is recognized, as is their added value," reminds Dr. Martin Leonhard, Chairman of Medical Technology in the SPECTARIS industry association. “The information is updated immediately and provided with instruction videos or multilingual content. Ultimately, the plus in flexibility and user-friendliness benefits those around whom everything revolves: the patients.”
With the survey results, MedicalMountains and SPECTARIS are entering into further dialogue with political decision-makers at national and European level. "We uphold the eIFU topic because it makes things easier for both manufacturers and users," emphasize Julia Steckeler and Dr. Martin Leonard. They are convinced that further opening up of EU regulations is not only desirable, but necessary - also in order to be able to make a valuable contribution to resource protection. “The will of the industry is there. The same is true of the will of users and clinics, which was revealed by the user survey conducted by MedicalMountains GmbH and SPECTARIS in 2021 among 400 users. Now all that is needed is the will of politicians.”
- The survey can be accessed free of charge via the MedicalMountains GmbH webshop under this link.
