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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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.
Pharmaceuticals
Commercial Contracts
Intellectual Property and Licensing
Testimonial
Axon supports pharmaceutical companies in licensing their products across Europe and beyond. We draft and negotiate licence agreements tailored to each market, helping clients maximise the value of their intellectual property.
Food and Feed
Medical Devices
Pharmaceuticals
Due Diligence
Testimonial
Axon regularly acts as a sub-contractor for leading international firms to assist in regulatory due diligence in our fields of expertise: pharma, medical technology and food.
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.
Healthcare
Medical Devices
Pharmaceuticals
Data Protection, (Cyber)security and AI
Testimonial
What distinguishes our lawyers is the ability to see the whole regulatory picture. We have assisted multiple clients, ranging from CROs to pharma start-ups to medical device manufacturers, in setting up GDPR compliance processes and agreements that allow for seamless interaction with other legal frameworks such as MDR and IVDR.
Healthcare
Pharmaceuticals
Due Diligence
Regulatory Compliance and Enforcement
Testimonial
We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.
Food and Feed
Medical Devices
Pharmaceuticals
Advertising and Claims
Litigation
Testimonial
We have advised several clients on the conduct and defence of complaints made to the Dutch Advertising Committee regarding claims about products such as foods, pharmaceuticals and medical devices across Dutch media.
Healthcare
Pharmaceuticals
Commercial Contracts
Regulatory Compliance and Enforcement
Testimonial
We have advised a client on collaborations between pharmaceutical companies and healthcare providers and contract research organisations, including the negotiation of framework agreements for clinical research.