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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Chemicals
Regulatory Compliance and Enforcement
Blog
EU law increasingly regulates the use of PFAS, the so-called "forever chemicals". For MedTech and pharma companies, the implications are significant and some restrictions already apply.
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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.
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.
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.
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.
Chemicals
Environmental and Sustainability
Regulatory Compliance and Enforcement
Testimonial
Our team has trained several multinationals on the implications of the Battery Regulation and the Packaging & Packaging Waste regulation, and regularly advises on these topics.
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.
Pharmaceuticals
Regulatory Compliance and Enforcement
Testimonial
We have advised pharmaceutical companies with legal advice across the full product lifecycle, from early-stage development through to market authorisation and post-marketing compliance.