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 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.

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

We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.

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.

One of our lawyers has acted as arbiter in international proceedings on MDR compliance.