Updates

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 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.

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

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

Axon advised a stock-listed biopharmaceutical company on antibody licensing and technology transfer agreements with two major US-based pharmaceutical companies. The deals involved the grant of commercial rights to the licensor's proprietary antibody platform technology.

We have advised pharmacies on the regulatory aspects of pharmaceutical compounding.

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.