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.

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.

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.

We have conducted regulatory due diligence on behalf of a private equity firm in connection with the acquisition of a medical device manufacturer, covering MDR compliance (including notified body certificates and post-market surveillance obligations), as well as data protection aspects.

We have advised on commercial contracting and borderline classification cases.

We have worked with a multinational medical device company to ensure compliance of its advertising materials with local advertising and promotion rules in the Netherlands.

We have advised several clients on legacy status and the impact of the targeted revision of the MDR and IVDR.

We have provided in-house training for the regulatory and quality teams of several large MedTech companies.