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 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 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.

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

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

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.

We have advised a medical device manufacturer on collaborations with academic institutions on data collection for training of AI systems, including the necessary data protection contracts.

We have assisted a medical device manufacturer in ensuring that their SAAS-application complies with the Data Act and the GDPR.