BioTalk

On 11 December 2024, the MHRA published an updated roadmap for the future of the regulatory framework for medical devices in the UK,...

* This article was co-authored with Olivia Zhao from Bird & Bird Lawjay Shanghai association team.  On 3 January 2025, the General Office...

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have announced a significant update to their guidance on...

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...

On 8 April 2024, the Dutch Minister of Medical Care (the Minister) sent a letter to the Dutch House of Representatives (Kamerbrief)...

Environmental awareness and the desire to limit or eliminate the impact of human activities on the environment have led to real political...

To add to all the chatter about AI, let’s talk about AI as a medical device. Last month, the Medicines & Healthcare products Regulatory...

While it might be challenging for manufacturers of medical devices to navigate the evolving regulations of medical devices in Great...

The rise in the volume of cyber incidents, the war in Ukraine, and the recent pandemic, has increased focus on the risks for medical...

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction of a 12-month extension to the...

The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure ceiling for medical devices in...