Medical devices

Legal certainty in a dynamic regulatory environment

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The legal field of medical devices is subject to constant change. At European level, directives and regulations govern the conformity, certification and distribution of medical devices. At national level, the Medical Devices Act and more specific ordinances supplement this framework. 

Our law firm supports companies and research institutions in all legal matters - from differentiation from other product groups to CE certification and market launch. With our many years of experience and expertise, we will guide you through the complex requirements of this highly regulated area.

Our services in the field of medical devices

Differentiation from medicinal products, cosmetics and foodstuffs
Clinical testing and CE certification of medical devices
Support with reimbursement issues in the statutory health insurance system (§ 140a and § 137h SGB V)
Advice on advertising and competition law
Representation vis-à-vis supervisory authorities and the BfArM
Strategic advice for national and international clients

A client from the medical device industry describes our collaboration:
"The law firm not only guided us through the certification process, but also supported us in the strategic orientation of our product in a highly regulated market. Their comprehensive expertise was a decisive success factor for our market launch." 

Prof. Dr. iur. Dr. med. Alexander Ehlers explains:
"The regulation of medical devices is not only a legal challenge, but also a strategic instrument for innovation in the healthcare sector. Our task is to guide clients through this process and at the same time provide them with the legal certainty they need for their business development." 

Whether start-ups, medium-sized companies or global corporations - our law firm understands the special requirements of the medical device industry and offers you tailor-made solutions for your legal and strategic issues. Rely on our expertise to bring your product to market safely and successfully.

Interested in working with us?

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