The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were officially signed into law on 10 April 2025, marking a significant development in the UK clinical trials framework (the Medicines for Human Use...more
On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for industry on the intended...more
On 12 December 2024 the statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK CTR) was laid before Parliament. The Medicines and Healthcare products Regulatory Agency (MHRA),...more
A draft Statutory Instrument was laid before UK Parliament on 22 October 2024 which, once passed, will introduce new post-market surveillance (PMS) requirements for medical devices and in vitro medical devices (IVDs) in the...more
The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more
The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more
'Go live’ of Unitary Patents and the corresponding Unified Patent Court (UPC) system in the EU is imminent. The UPC system has particular relevance to life sciences and technology transactional and commercial contracts where...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran between September and November...more
At our recent Health Care AI Law and Policy Summit, Hogan Lovells attorneys Dan Whitehead, Bonella Ramsay, Louise Crawford, and Imogen Ireland convened with industry leaders virtually at the Health Care AI Law and Policy...more
UK pharmaceutical companies have historically relied upon consent as the lawful basis for the disclosure of healthcare professionals’ personal data relating to transfers of value. However, the low consent rates and the...more