Jun 18, 2024 CJEU AG opinion: pharmaceutical company has EU VAT refund rights following ex lege payments to state health insurance body By Andy van Esdonk On June 6, 2024, the Advocate General (AG) at the Court of Justice of the European Union (CJEU) delivered an opinion in case C-248/23...
Apr 30, 2024 Developments in the Netherlands on preventing unwanted influence of healthcare professionals by medical companies By Hester Borgers Jephta Zantinge On 8 April 2024, the Dutch Minister of Medical Care (the Minister) sent a letter to the Dutch House of Representatives (Kamerbrief)...
Sep 28, 2023 Circular economy: what impact for healthcare players? By Alexandre Vuchot Johanna Harelimana Nour Saab Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment have led to real political...
May 22, 2023 AI as a Medical Device By Sophie Vo To add to all the chatter about AI, let’s talk about AI as a medical device. Last month, the Medicines & Healthcare products Regulatory...
May 10, 2023 Proposed updates to the regulation of medical devices By Sophie Vo While it might be challenging for manufacturers of medical devices to navigate the evolving regulations of medical devices in Great...
Feb 17, 2023 The Impact of the NIS2 Directive and the CER Directive for Medical Device Manufacturers and the Healthcare Sector By Deirdre Kilroy Georgina Parkinson The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased focus on the risks for medical...
Oct 31, 2022 Update on the UK’s future medical device regulations: Extended timelines By Pieter Erasmus The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction of a 12-month extension to the...
Oct 07, 2022 The Activation of Payback on Medical Devices By Simone Cadeddu Mauro Turrini The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure ceiling for medical devices in...