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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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.
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.
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.
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.
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.
Medical Devices
Litigation
Testimonial
One of our lawyers has acted as arbiter in international proceedings on MDR compliance.
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.
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.