Legal advice on medical devices

Medical devices

Developing innovative, safe and compliant medical devices.

We support the development and approval of products that balance innovation and regulation, with a focus on MDR, data protection and IT security.

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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.

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Intro

Our motto: secure, radical, digital.

SRD is the boutique law firm for digital projects, supporting you from kick-off to go-live. We combine technical innovation with compliance. We create radically clear legal scope for this.