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8/16/2023
Sustainability
News
How much paper can be saved through eIFUs?
More than half of the medtech companies are aware of the explicit customer request for electronic instructions for use, so-called eIFUs, but only a fraction may exclusively provide them. This is the result of the current industry survey by MedicalMountains GmbH and SPECTARIS. The joint appeal is therefore to expand the existing legal framework in terms of product safety, but also sustainability.
Currently, the sole use of digital instructions for use for medical devices is limited to a few product groups. This is due to EU Regulations 2021/226 and 2012/207, which deny the majority of medical devices a pure eIFU. This is also confirmed by the results of the current survey. 43 percent of the participating companies provide eIFUs for the EU market, of which about two-thirds supplement the paper version – this leaves a share of only about 18 percent of all companies that can focus on a purely digital version. The main obstacle cited is the existing legal framework. Its expansion is considered desirable and sensible by 76 percent of the companies.
With the survey results, MedicalMountains and SPECTARIS are entering into further dialogue with political decision-makers at national and European level. "We hold the topic of eIFU in high regard, because it provides relief for both manufacturers and users," emphasise Julia Steckeler and Martin Leonhard. They are convinced that a further opening of the EU regulations is necessary – also to be able to contribute to resource protection.
Advantages of eIFUs
The digital instructions for use are available quickly and up to date, can be searched, archived, and found more easily, and additional information can be added flexibly – points that come into play both within and outside the EU. In addition to flexibility and user-friendliness, environmental aspects speak in favour of eIFUs. A complete switch to digital instructions for use could save about 500 tonnes of paper per year and company in Germany, according to feedback from the industry: an average of 482 tonnes for documents for professional use and 522 tonnes for all products.Digital instructions for use as the new common standard
"You can't push digitalisation and demand sustainability, but at the same time put the brakes on instructions for use in such a way," emphasises Julia Steckeler, Managing Director of MedicalMountains GmbH, and calls for a paradigm shift: "The eIFU should be the rule in future and the printed version a supplement at the customer's request." The advantages are "obvious" and there is no loss of security. On the contrary: "The use of eIFUs is recognised, as is their added value," reminds Martin Leonhard, chairman of medical technology in the industry association SPECTARIS. "The information is updated immediately and provided with instruction videos or multilingual content. The added flexibility and user-friendliness ultimately benefit 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 hold the topic of eIFU in high regard, because it provides relief for both manufacturers and users," emphasise Julia Steckeler and Martin Leonhard. They are convinced that a further opening of the EU regulations is necessary – also to be able to contribute to resource protection.
