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.

EU Biotech Act and Food and Feed Safety Simplification Omnibus: what’s in it for the food and feed sector?

December 2025 brought two major regulatory proposals from the European Commission: the first part of the EU Biotech Act and the Food and Feed Safety Simplification Omnibus. Together they promise regulatory sandboxes for testing innovative products, a broader advisory role for EFSA, tailored rules for genetically modified micro-organisms, and a move from time-limited to unlimited approvals for substances with proven safety records. For food and feed businesses, that translates into faster market access, lighter administrative burdens and more legal certainty, provided the underlying safety standards keep pace.

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.

A Nordic company owns a proprietary technology for producing legume-based meat alternatives. Axon drafted technology licensing agreements and developed an IP strategy covering patents and trade secrets, with practical checklists for implementation.

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.

Axon helped The Protein Brewery rename its novel food product. We proposed consumer-friendly alternatives to the European Commission, resulting in an approved name the client is very happy with.

Axon assisted a French VC company investing in a food tech start-up. We reviewed the target’s regulatory strategy under the EU novel foods framework, assessed its feasibility and outlined potential risks and how to mitigate these.

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.

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