Updates

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

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

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.

Axon advised a Dutch joint venture, that is active within the agri-food and agricultural biotechnology sector, on the transfer of its assets to a German investment fund. The transferred assets involved patent rights, plant breeders’ rights, trade secrets and biological materials.

Axon acted on behalf of an investor in connection with their investment in a clinical-stage biotech company developing first-in-class therapeutics and diagnostics for fibrosis. We conducted legal due diligence on the target company and reviewed the transaction documentation on behalf of the investors.