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.

New working arrangements between Dutch Food Safety Authority and Inspection Board Health Products

In the Netherlands, advertising disputes over health products rarely reach the civil courts. Instead, self-regulation by the Inspection Board plays a central role, working hand in hand with the Dutch Food Safety Authority (NVWA). New working arrangements between the two bodies, in force until the end of 2027, set out exactly when a case stays within self-regulation and when NVWA steps in directly. With the line between a lawful health claim and an unauthorised medical claim often razor-thin, knowing which route applies matters.

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.

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

We have trained the entire regulatory team of a medical device company on understanding GDPR compliance in a clinical research setting.

We have advised a medical device manufacturer on the qualification and classification of a borderline product, including the determination of the correct regulatory pathway under the MDR and the mitigation of associated compliance risks.