While procedures prevail on the European market for the greater good of its citizens, it might be daunting when trying to introduce a product, whether innovative or not. In the current world, Cyber-Physical Systems (CPSs) are ubiquitous in our daily lives. Cars can provide intrusive assistance as they can brake or turn wheels on their own, buildings are getting smarter to optimize energy consumption, smart cities are emerging to facilitate information sharing and orchestrate the response to emergency situations, etc. As the presence of such tools will grow in the coming years and people will rely even more on CPSs, we certainly need to ensure that they are safe and reliable for users or everybody else, which is why regulations are so important. However, compliance should not act as a barrier to new actors coming to the European market. Nor should it prevent current actors from keeping systems deemed compliant when introduced while obsolete at the time they are used. While the individual elements we point out might not bring novelty in the various research areas we cover (EU policies, requirements engineering, business engineering, and software engineering), this paper identifies the challenges related to building and testing a CPS with respect to applicable laws and discusses the difficulty of automating the response to those challenges, such as finding a relevant legal text, paying for mentioned materials or identifying the level of compliance to a legal text. Our analysis of the holistic context when considering the compliance testing of CPS provides an overview enabling more effective decision-making as well.

翻译：尽管欧盟市场为保障公民福祉而推行各类程序，但在引入产品（无论是否具有创新性）时仍可能面临重重阻碍。在当今世界，信息物理系统已渗透至日常生活的方方面面：汽车可提供侵入式辅助功能，实现自主制动或转向；建筑日益智能化以优化能耗；智慧城市不断涌现，促进信息共享并协调应急响应等。随着此类工具在未来数年的普及以及人们对信息物理系统的依赖日益加深，我们必须确保其对用户及所有相关方的安全性与可靠性——这也正是监管法规至关重要的原因。然而，合规要求不应成为新参与者进入欧盟市场的壁垒，也不应阻碍现有参与者在系统投入使用后，因技术迭代而无法维持其最初认证的合规状态。尽管本文指出的具体要素在所涉研究领域（欧盟政策、需求工程、业务工程与软件工程）中未必具有新颖性，但本文系统阐述了在适用法律框架下构建与测试信息物理系统所面临的挑战，并探讨了应对这些挑战的自动化难题，例如检索相关法律文本、支付文献获取费用或判定法律文本的合规等级。通过对信息物理系统合规测试整体背景的分析，本文亦为提升决策效能提供了系统性视角。