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.

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 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 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.

On behalf of a medical device company, we reported a personal data breach to the supervisory authority and have advised on internal communication.

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