Medical Device Legal News with Sam Bernstein: Episode 18
JONES DAY PRESENTS®: Harmonizing Global Protections: The EU Trade Secret Directive
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
On 24 January 2024, the European Commission (EC) published its proposed reform of foreign investment screening in the EU. The proposal introduces more comprehensive rules for the review of foreign investments and strengthens...more
On 22 December 2023, the EU published Regulation (EU) 2023/2854, the Data Act, in the Official Journal of the EU. The Data Act is a new regulation providing harmonised rules on access to data, switching cloud providers and...more
The regulation aims to harmonise clinical and scientific aspects of HTA to make innovative health technologies more widely available in the EU. Health technology assessment (HTA) is a multidisciplinary evidence-based...more
The European Parliament recently adopted a new regulation on crowdfunding platform activity. This regulation will apply across the board to all European Union countries. The regulation’s adoption sprang from the desire to...more
Companies should act now to prepare for the full implementation of the MDR and IVDR. On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...more
On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more