Legal Advice for the Development of Medical Devices
The development of medical devices requires not only innovation, but also a deep understanding of strict regulatory requirements. From MDR compliance, data protection and IT security to market authorisation, our specialist lawyers provide comprehensive advice to ensure that your medical device is brought to market safely and in compliance with the law.
What areas do we support medical device developers in?
Our consulting services focus on the digital aspects of medical devices. This includes data processing in any form, software, apps and AI systems. In particular, we focus on the following challenges:
- Software as a medical device:
You are at the beginning of development/approval and wonder whether your product is or should be a medical device, which risk class according to MDR your medical device falls into and which specific requirements need to be observed in each case? - AI medical devices:
Are you wondering whether your medical device falls under the AI Act and whether it is classified as a so-called high-risk AI system? Do you need advice on the entire lifecycle of an AI medical device and what specific requirements need to be considered? - Connected medical devices:
The Internet of Medical Things comprises interconnected devices and applications used in medical and health information technology. These generate large amounts of data, the access and use of which must be carefully regulated. Manufacturers are facing increasing regulatory requirements, in particular the Data Protection Act. - Competition law and the law on the advertising of therapeutic products:
Are you wondering whether or how you can advertise your medical device? Have you received a warning letter from competitors and/or a competition authority? - Selective contracts with health insurers:
Do you want to cooperate with a health insurance company and need assistance? - Drafting of contracts
- Data protection and IT security
- DiGA/DiPA
How we can help you with medical devices
- Comprehensive data protection and information security advice:
We can help you comply with GDPR and other data protection regulations, as well as IT security. - Data protection audits and DPIAs:
We conduct data protection audits and compliance assessments, including data protection impact assessments. - Contract drafting and review:
We draft and review contracts specifically tailored to the needs of medical devices. - Software as a medical device:
We take care of the delineation, qualification and classification of your software. We identify the relevant regulatory requirements and advise you on the specific implementation of the specifications. - AI medical devices:
We take care of the delineation, qualification and classification of your AI medical devices. We identify the relevant regulatory requirements and advise you on the specific implementation of the specifications. This includes regulatory advice throughout the entire lifecycle of the AI. - DiGA/DiPA:
Advice on the full lifecycle of a digital health application (DiGA) or digital care application (DiPA) and which specific requirements need to be considered in your case. - Connected medical devices:
We help you to correctly interpret and implement the requirements of the Data Act. We can check whether you qualify for exemptions for small and micro businesses. We can help you identify exactly what data is covered by the Data Act. - Compliance training:
We provide tailored training for your team to ensure that everyone is aware of the legal requirements in the eHealth sector.
Why Schürmann Rosenthal Dreyer is your partner for medical devices
Schürmann Rosenthal Dreyer combines 16 years of legal expertise with in-depth technical know-how to provide you with comprehensive solutions in the field of medical devices. Our firm brings together experienced lawyers and technology experts to ensure that your digital healthcare projects are legally compliant and future-proof. As initiators of the Health & Law network, we are deeply involved in healthcare law and are committed to the legal protection of innovative healthcare solutions.
Our expertise has been recognised many times: We won the prestigious JUVE award for Law Firm of the Year in Data Protection and IT, and are ranked as one of the top 2024 law firms by The Legal 500.
Put your trust in Schürmann Rosenthal Dreyer - the partner who will lead your projects to success with a unique combination of legal excellence and technical understanding.
No-obligation initial medical device consultation
Arrange a no-obligation initial consultation with our specialist solicitors to discuss your situation and your need for advice!
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