Updates

CJEU clarifies medical devices distributors due diligence obligations under MDR and IVDR

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.

Axon drafted a cooperation agreement between an agro crop improvement company and four other companies, being both shareholders and competitors at the same time.

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.

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.

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.

We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.

Our team negotiated a cooperation agreement between a cosmetics brand owner and a manufacturer on behalf of a mid-sized company.

We advised a mid-sized company on the qualification of a cosmetic product to facilitate its compliant and effective market launch.

Our team assisted a mid-sized cosmetics company with the negotiation of a distribution agreement.

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.