Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.
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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 have assisted a distributor of medical devices on questions pertaining to a cleaning solution regulated under the Biocidal Product Regulation.
We have advised a medical device manufacturer on the regulatory implications of the restriction on synthetic polymer microparticles for its products.
We have advised a start-up on the legal limitations and requirements related to the transport of dangerous substances.
Our team advised a client on the registration process under REACH.
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.