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.

The PFAS proposal: what is it, and where does it stand?

EU law increasingly regulates the use of PFAS, the so-called "forever chemicals". For MedTech and pharma companies, the implications are significant and some restrictions already apply.

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.

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.

Our team has trained several multinationals on the implications of the Battery Regulation and the Packaging & Packaging Waste regulation, and regularly advises on these topics.

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

We have advised a start-up on the legal limitations and requirements related to the transport of dangerous substances.

We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.

We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.