Our focus: The legal requirements for medical devices, IVD, and digital health solutions.
Medical devices are subject to an increasingly complex interplay of regulatory requirements. In addition to the classic requirements of medical device law regarding product safety, conformity, and liability, digitization, data-based business models, and new horizontal regulations from other areas – such as in the context of the European Green Deal – are becoming more important. The new regulations are becoming increasingly intertwined and are shaping the entire product life cycle.
Product safety and product liability
The regulatory landscape for medical devices and IVDs is becoming increasingly complex: MDR, IVDR, and national medical device regulations form the central regulatory framework with specific safety and performance requirements for these products as a market entry threshold. These requirements are supplemented by further regulatory requirements, e.g., in sustainability and chemical law. With our 360° compliance approach, we advise manufacturers, importers, distributors, and suppliers on identifying the relevant regulatory obligations and product requirements, as well as on implementing robust compliance management systems. Our team offers practical solutions for communication within the supply chain, but also with notified bodies and market surveillance authorities, especially in the context of market measures and recall scenarios.
Digital Health
Digitalization is fundamentally changing the health sector. Medical devices are increasingly software-based or networked, and data-driven systems, AI-supported functions, and digital platform solutions are shaping new products, processes, and business models. This also significantly increases regulatory complexity. Our Digital Health Team provides comprehensive support to clients from across the healthcare ecosystem in digitalization projects and digital health solutions – from conceptual and strategic alignment to implementation, monitoring, and further development. We combine regulatory expertise with a deep understanding of digital technologies, data-driven processes, and the specific requirements of the healthcare sector.
The team
Christina Ziegler-Kiefer
Senior Associate
- T + 49 681 / 859 160 0
- E christina.ziegler-kiefer@reuschlaw.de
Ensuring legal compliance and efficiency in the healthcare sector
We provide our clients in the healthcare sector with continuous, solution-oriented support—in planning their business case and market entry, in their day-to-day business, and in crisis situations. Our aim is to implement regulatory requirements in a legally compliant and efficient manner and to support companies with practical solutions that enable reliable and manageable compliance in everyday business. These include in particular:
- Identification of regulatory requirements for the entire life cycle of medical devices, IVD, and digital health solutions
- Questions regarding product safety, conformity, and product liability
- Support with market access as well as market surveillance and market measures, including recalls and warnings
- Advice on dealing with authorities, notified bodies, customers, suppliers, and other market players
- Contract desgin
- Support for digitization projects in the health and MedTech environment
- Advice on digital business and distribution models
- Guidance on avoiding regulatory risks and support in crisis and conflict situations
Medical devices and digital health: We support our clients in all legal matters related to products and services in the healthcare sector. Contact us!
Downloads
Department brochure: Regulatory Affairs and Healthcare 2025
