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Latest Life Sciences News

MDCG updates guidance on IVD verification and vigilance reporting

The Medical Device Coordination Group (MDCG) has released two revised documents providing updated guidance for the medical device industry.

FDA issues draft guidance on AI-enabled medical device software

The U.S. Food and Drug Administration (FDA) has released draft guidance on artificial intelligence (AI)-enabled device software functions, focusing on lifecycle management and marketing submission recommendations. The guidance advocates a total product lifecycle approach to ensure safety and effectiveness, covering design, development, implementation, and documentation aspects. It addresses transparency and bias considerations, complements recent guidance on predetermined change control plans, and encourages early engagement with the FDA. The draft is open for public comment until 7 April 2025, aiming to provide comprehensive recommendations for AI-enabled medical devices throughout their lifecycle.

UK medical devices regulatory reform—where are we now and what’s next for 2025?

Life Sciences analysis: The UK Medicines and Healthcare products Regulatory Agency (MHRA)’s plans for reforming the medical devices regulatory framework post-Brexit have begun to take more concrete shape, with recent developments in the form of new Post Market Surveillance (PMS) regulations presented before Parliament in October 2024 and further consultation issued by the government concerning specific aspects of the new core regulations. 2025 will be a critical year, with the keystone draft ‘core’ legislation anticipated. Written by Harriet Hanks, counsel, Andrew Austin, partner, Emily Bloxsome and Honor May, associates, and Charlotte Case, trainee.

UPC Court of Appeal remits Meril’s request to stay infringement proceedings pending the outcome of EPO opposition

EU Law analysis: The Unified Patent Court’s (UPC) First Panel of the Court of Appeal (CoA) sitting with only three Legally Qualified Judges, has remitted Meril’s application to the Nordic-Baltic Regional Division (RD) to stay infringement proceedings brought by Edwards pending the outcome of Meril’s European Patent Office (EPO) opposition against EP No. 3,769,722. This was on the basis that the Nordic-Baltic RD had erred in refusing the application solely on the basis that a rapid final decision could not be expected from the EPO. The CoA also confirmed that the UPC Rules of Procedure only allowed the Court to disregard requests, facts and evidence that were not submitted at first instance. However, new arguments could be submitted at appeal if they were based on existing facts and evidence. Hsu Min Chung, partner and patent attorney, and Rachel Fetches, partner and Head of Law, at HGF analyse the judgment.