Survey: Suitability of the legal framework for a digitized Quality Infrastructure

New digital solutions in QI, both on a technical and procedural level between actors, affect companies (manufacturers/distributors/operators) as well as authorities/public administration (approvers, market surveillance authorities, etc.), private sector conformity assessors and other stakeholders.

However, the existing legal framework - from European directives as part of the New Legislative Framework, to German federal legislation, technical regulations and municipal ordinances - can sometimes be designed in such a way that it hinders the introduction and use of new, digital solutions. This can affect various areas of application - from product safety, environmental and consumer protection to commercial law.

The question therefore arises as to what extent the existing legal framework is suitable for digital QI.

This is followed by questions about existing hurdles, obstacles, but also potential, as well as the need for adaptation and design options. A legal framework that does justice to the necessary digitalisation of QI enables and promotes innovation, ensures competition and competitiveness, enables efficiency increases in bureaucratic processes/reduction of bureaucracy and creates legal certainty.

1.     The aim of the study is to make statements about how, to what extent and in which areas the current law promotes or hinders the digitalisation of QI - both structurally and in very concrete, specific aspects and examples. In addition, starting points for further supporting the objectives of digital QI are identified.
2.     The study will also examine the potential of the concept of the federal government's real-world laboratories as regulatory sandbox for innovation and regulation in the context of the digitalisation of QI. Specific use cases will also be identified and evaluated, which can then be implemented as part of QI-Digital.
3.     The results of the study will be used to create a specific checklist (a guidance document) with concrete recommendations for good legislation and regulation that promotes the digitalisation of QI.

The study will be completed in autumn 2024.

The project was commissioned and is supported by the Federal Institute for Materials Research and Testing in cooperation with the Advisory Board of the Initiative QI-Digital (Focus Group Regulatory Framework). For more informations please contact Dr Claudia Koch via info[at]qi-digital.de.