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 large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.

We have advised manufacturers, distributors and authorised representatives on all aspects of the IVDR, including assisting a diagnostics manufacturer with the classification and conformity assessment of its in vitro diagnostic medical devices under the new IVDR framework.

We have guided several clients through notified body interactions and discussions with competent authorities on product classification.

We have supported an IVD manufacturer in the design and conduct of performance studies. We regularly advise clients on post-market performance follow-up (PMPF) obligations.

We have assisted multiple manufacturers with the transition of their legacy IVD Directive products to the IVDR framework.

Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.

We have advised an IVD manufacturer on a bringing companion diagnostic to market with respect to a patient support program.

We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.

We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.