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 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.

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.

We have provided in-house training for the authorised representative of a large multinational on its obligations under the MDR.

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.

We have advised a start-up on enforcement actions brought by the Dutch Healthcare Inspectorate (IGJ) concerning MDR compliance.

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.

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.

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.