MDR, IVDR, Digital Health & Sustainability — All from a Single Source
The healthcare sector faces new challenges due to the increasing connectivity of products and growing regulatory complexity. Our 360° compliance approach addresses this complexity by treating digital aspects as an integral part of the process and taking into account all regulatory requirements throughout the entire product lifecycle.
Challenges
The European Economic Area is distribution and target market for medical devices, in vitro diagnostic medical devices (IVD), and digital health solutions. The Medical Device Regulation (MDR) and In vitro diganostic Medical Device Regulation (IVDR) constitute the regulatory framework for the distribution of these products. However, in addition to these requirements, further product-specific and company-specific obligations must be observed throughout the entire product life cycle, ranging from development and manufacturing to product information and labeling, as well as packaging and disposal of products and services.
As digitalization increases, so does regulatory complexity. New tools such as health apps, smart gadgets and wearables, artificial intelligence (AI), and interoperable platform solutions support and accompany diagnosis, therapy and care. Data-driven systems and the secondary use of health data are also shaping new business models. In this context the requirements under medical device law and digital law (such as data law, data protection, cybersecurity law, and AI regulation) are intertwined and govern the development, introduction, and operation of these products and services.
At the same time, new regulations in other areas are having an impact on the healthcare sector. The European Green Deal has tightened existing requirements and introduced new regulations with additional provisions that are also relevant to medical devices, such as the Ecodesign Regulation and Packaging Regulation. In addition, substance-related regulations such as the REACH Regulation and the RoHS Directive are particularly relevant. Through the CE marking, manufacturers also confirm that their products comply with these regulations. Therefore, compliance must be comprehensively verified and documented.
Solution: 360° Compliance
reuschlaw advises stakeholders in the healthcare ecosystem on the applicability of relevant European and national regulations governing design, development, and production, as well as placing on the market, distribution, post-market surveillance, and disposal of medical devices, IVDs, and digital health solutions. Our 360° compliance service provides you with an overview of the applicable obligations in each specific case. We also provide support with audit-compliant contract drafting (B2C and within the supply chain), communication with Notified Bodies and regulatory authorities, as well as FSCA and recall management.
Get in touch with us!
Please feel free to contact us at any time if you need our assistance or have any questions. We are happy to explain our approach to you in a one-on-one conversation.
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