The medical device industry is facing a paradigm shift in which the focus is no longer solely on specific medical device legislation. Business players need to keep pace with the regulatory impact of the European Green Deal and at the same time make the most of the opportunities presented by digitalisation and AI solutions.
The challenge
The European Economic Area is an attractive sales market and distribution target for medical devices and IVDs. The MDR and IVDR offer a standardised set of regulations that reflect the special requirements for medical devices and IVDs. However, the conformity of products with the requirements of MDR and IVDR is only the obvious basis. Additional regulatory requirements may also apply to medical devices and IVDs. From development and production to product information and labeling through to packaging and disposal, environmental regulations in particular must be heeded. Legislation as part of the European Green Deal has significantly tightened existing requirements or implemented new regulations, including the REACH Regulation (PFAS requirements), the RoHS Directive, the Ecodesign Directive, the Green Claims Regulation, the Corporate Sustainability Reporting Directive, the Battery Regulation and packaging regulations, to name but a few. Digital products or those with AI components must also fulfil cybersecurity requirements and the requirements of the AI Regulation. By affixing the CE mark, manufacturers also declare conformity with these supplementary or additional horizontal regulations.
Our focus: medical devices
The regulatory requirements for medical devices and IVDs, including digital health applications such as medical apps, across the entire life cycle are complex and continue to increase as regulation progresses, even independently of the MDR and IVDR. Manufacturers, but also importers, distributors and suppliers are required to ensure the safety and performance of their products along the supply chain. Our team offers support with all legal issues relating to medical devices and IVDs. For more than ten years, we have been advising economic players on the implementation of a reliable compliance management system and offer practicable solutions for communication with one another as well as with Notified Bodies and market surveillance authorities – especially in the context of market measures and recall scenarios.
The team
360° compliance for medical devices – analogue and digital
The reuschlaw Healthcare Department advises manufacturers of analogue and digital medical devices and IVDs on the applicability of all product-specific European regulations with an impact on product compliance along the entire life cycle of the products. Our “360° Compliance for Medical Devices” consulting approach gives economic players a clear overview of the obligations arising for them from the respective regulations.
We support our clients in identifying gaps in the existing system and thus recognising product safety risks and avoiding liability risks. This applies in particular to regulations that have been significantly tightened or newly implemented as part of the European Green Deal. We are also available for the “audit-proof” drafting of contracts between stakeholders, communication with notified bodies and FSCA and recall management in dialogue with the market surveillance authorities.
For digital products or products with AI components, we work with our experienced Digital Business Unit to advise on the applicable cybersecurity requirements and the provisions of the AI Regulation.
We also provide support with
- Qualification and classification of products;
- Marking and labeling (CE and UKCA);
- Evaluation of declarations of conformity, instructions for use and marketing materials;
- Inclusion of DiGA in the DiGA directory (Fast Track Process);
- Health and patient data protection;
- Roll-out of necessary market measures and communication with authorities and customers in worst-case scenarios.
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We help our clients with all legal issues relating to medical devices throughout their entire life cycle. Nationally and internationally. Contact us!