The Court of Justice (CJEU) clarified distributor obligations under Article 14 MDR (and IVDR) recently in the Dürr Dental case (C-10/24). Spoiler: it's not surprising but clarifying, with a dash of novelty.
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Agriculture
Commercial Contracts
Testimonial
Axon drafted a cooperation agreement between an agro crop improvement company and four other companies, being both shareholders and competitors at the same time.
Agriculture
Biotech
Food and Feed
Regulatory Compliance and Enforcement
Spin-out and Starter Advisory
Testimonial
As a partner of StartLife, Axon assisted a feed company with the regulatory qualification of its technology. Our reasoned opinion serves as a key document for the company’s funding activities.
Diagnostics
Food and Feed
Commercial Contracts
Intellectual Property and Licensing
Spin-out and Starter Advisory
Testimonial
Axon assisted a start-up developing a real-time diagnostic test to define pathogens food. We negotiated and drafted an agreement with a university to support the further development & validation of the technology.
Digital Health
Medical Devices
Data Protection, (Cyber)security and AI
Testimonial
We have assisted a medical device manufacturer in ensuring that their SAAS-application complies with the Data Act and the GDPR.
Digital Health
Medical Devices
Regulatory Compliance and Enforcement
Testimonial
We have advised several clients on the classification of their medical devices, including software products, under the MDR and IVDR, and have helped them in negotiating.
Diagnostics
Pharmaceuticals
Regulatory Compliance and Enforcement
Testimonial
We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.
Diagnostics
Regulatory Compliance and Enforcement
Testimonial
We have advised manufacturers, distributors and authorised representatives on all aspects of the IVDR, including assisting a diagnostics manufacturer with the classification and conformity assessment of its in vitro diagnostic medical devices under the new IVDR framework.
Digital Health
Healthcare
Regulatory Compliance and Enforcement
Testimonial
We have advised a digital health start-up on the qualification of its services under Dutch healthcare law, including the determination of whether the company qualifies as a healthcare provider and the resulting regulatory obligations.
Digital Health
Data Protection, (Cyber)security and AI
Regulatory Compliance and Enforcement
Testimonial
We have advised a telehealth provider on its data processing strategy in connection with the roll-out of a new digital platform, including advising on cross-border data exchange requirements for the provision of digital healthcare services.