Updates

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.

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

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

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

We advised a mid-sized company on the qualification of a cosmetic product to facilitate its compliant and effective market launch.

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

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.

Our team negotiated a cooperation agreement between a cosmetics brand owner and a manufacturer on behalf of a mid-sized company.