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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Food and Feed
Healthcare
Advertising and Claims
Regulatory Compliance and Enforcement
Blog
In the Netherlands, advertising disputes over health products rarely reach the civil courts. Instead, self-regulation by the Inspection Board plays a central role, working hand in hand with the Dutch Food Safety Authority (NVWA). New working arrangements between the two bodies, in force until the end of 2027, set out exactly when a case stays within self-regulation and when NVWA steps in directly. With the line between a lawful health claim and an unauthorised medical claim often razor-thin, knowing which route applies matters.
Read on foodhealthlegal.eu →
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.
Medical Devices
Regulatory Compliance and Enforcement
Spin-out and Starter Advisory
Testimonial
We have advised a start-up on enforcement actions brought by the Dutch Healthcare Inspectorate (IGJ) concerning MDR compliance.
Cosmetics
Regulatory Compliance and Enforcement
Testimonial
Axon assisted a cosmetics company facing enforcement by the Dutch Food and Consumer Product Authority NVWA re. the sample service it operated. Axon advised the company on the applicable CPNP notification and labelling requirements, based on which the company could ensure compliance.
Medical Devices
Regulatory Compliance and Enforcement
Testimonial
We have assisted a manufacturer of medical devices in obtaining a derogation from conformity assessment procedures under the MDR in the interest of public health.
Medical Devices
Regulatory Compliance and Enforcement
Testimonial
We have provided in-house training for the authorised representative of a large multinational on its obligations under the MDR.
Biotech
Healthcare
Commercial Contracts
Intellectual Property and Licensing
Testimonial
Axon assists medical technology companies in structuring their collaborations with hospitals and universities. We draft and negotiate cooperation agreements that protect our clients’ IP while fostering innovation.
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
Regulatory Compliance and Enforcement
Testimonial
We have advised a client on an inspection by the Dutch Healthcare Inspectorate (IGJ).