tekom Supports Jointly Developed Position Paper – The Importance of Information for Use in Electronic Form

Claudia Klumpp

Information for use in digital form is already commonplace in many industries. First and foremost, the software industry has already been working mainly with electronically provided information for use for years.

As early as 2015, a tekom survey showed that 75% of all software companies surveyed had a print share of less than 25%, measured in terms of the total documentation volume. In contrast, 50% of the industrial companies surveyed had a print share of 75% or more.

The European Union initiated an advance in a very sensitive area – medical devices – years ago. Regulation (EU) No. 207/2012 on electronic instructions for use of medical devices regulates the conditions under which instructions for use of medical devices may be made available in electronic form instead of paper. However, the regulation has not been a resounding success. The requirements were considered too onerous by many companies. In particular, the stipulation that the paper version must be provided within 7 calendar days at the latest upon customer request was a K.O. criterion for many.

Most of the European Product Safety Directives make no statement on the paper/digital issue.

The legally non-binding guidance documents (Blue Guide, Guide to Application of the Machinery Directive) make outdated and questionable statements on this issue. This simply leads to legal uncertainty, which ultimately prevents the economy from developing further in this area.

The Machinery Directive is now being revised. This Directive also has an impact on other directives such as the Low Voltage Directive. A regulation of instructions in digital form in the Machinery Directive would spark other product safety directives.

For this reason, more than a year ago, numerous representatives of associations and larger industrial companies came together in a DKE working group chaired by Dr. Claudia Klumpp (tekom) to draw up a position paper. The position paper is aimed at politicians and shows that there is no way around clarifying instructions in digital form. The following persons contributed to the position paper:

• Artur Bondza, head of content & product information management, Pepperl+Fuchs SE
• Kevin Behnisch, head of department smart technologies and industry, VDE Testing and Certification Institute
• Udo Keul, technical editor of MTM documentation, Endress+Hauser SE+Co.
• Thomas Kraus, VDMA, Technology, Environment and Sustainability
• Matthias Kurrus, head of technical documentation, Sick AG
• Jens-Uwe Heuer James, attorney, Luther Rechtsanwaltsgesellschaft mbH
• Roland Schmeling, CEO of SCHMELING + CONSULTANTS

The position paper was introduced to the tekom Deutschland expanded board of directors as well as the assembly of delegates, where it was given full support. Please disseminate this position paper to help compel politicians to clarify this issue.