The regulatory regime for medical devices, technologies and diagnostics is complex and undergoing its most significant change since the 1990s. We help clients prepare for and manage these changes and to consider the strategic opportunities that these changes bring.
We have particular experience helping clients to navigate the complicated area of borderline product classification, and in challenging regulatory decisions.
We also have close interests in genomic medicine, bioinformatics and their convergence with Internet-mediated devices. Our team played a key role in convincing the Council of the European Union to agree significant changes to the EU In Vitro Diagnostics Regulation.
Industry bodies such as the ABHI and MedTechEurope play an important role in the sector: they have developed Codes of Business Practice that can be an alternative mechanism for resolution of disputes between competitors. We have experience advising in relation to these Codes and have good relationships with these bodies.
Ensuring regulatory compliance in medical technologies contracts is critical. We have a great deal of experience structuring and drafting agreements in light of the regulatory framework.