In a highly competitive sector that evolves rapidly, our team monitors the full regulatory perimeter of medical devices and in vitro diagnostic medical devices.
Medical Devices & In-Vitro Diagnostics
We advise on Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), including device classification, conformity assessment routes, clinical evaluation under MDR Annex XIV and performance evaluation under IVDR Annex XIII, technical documentation under Annex II and III, GSPR compliance, UDI assignment, EUDAMED registration, post market surveillance, PMCF and PMPF plans, periodic safety update reports and vigilance obligations. We support clients on Notified Body audits, on transitional provisions under Regulation (EU) 2023/607 and Regulation (EU) 2024/1860, and on the integration of harmonised standards including ISO 13485, ISO 14971, EN 62304 and IEC 62366. We advise on Software as a Medical Device (SaMD) and on Medical Device Artificial Intelligence (MDAI) at the intersection of MDR/IVDR and the EU AI Act under Regulation (EU) 2024/1689. Our practice covers market access and reimbursement, product liability under the new Product Liability Directive (EU) 2024/2853, advertising, public tenders, supply and distribution agreements and interactions with HCPs and HCOs. We also advise on cybersecurity for medical devices under Regulation (EU) 2024/2847 (Cyber Resilience Act) and Directive (EU) 2022/2555 (NIS2).