Life Sciences weekly highlights—21 November 2024
This week's edition of Life Sciences weekly highlights includes analysis by Taylor Wessing of the new UK post-market surveillance statutory instrument to amend the Medical Devices Regulation 2002 as the first major piece of UK medical devices legislation post-Brexit and Law360 analysis of the General Court’s ruling that Boehringer Ingelheim cannot keep its three-dimensional trade mark over a lung disease inhaler because its shape is functional rather than decorative. Also included, is news that the MHRA has launched a consultation on proposed changes to the medical device regulation focusing on UKCA marking, international reliance, in vitro diagnostic devices, and assimilated EU law; news that the MHRA is consulting on ICH E6(R3) Good Clinical Practice Guideline; the MHRA is relaunching a revised Innovative Licensing and Access Pathway (ILAP) in March 2025; the EMA issued guidance for marketing authorisation holders regarding the submission of variations for 2024; NICE offered guidance to pharmaceutical companies considering the International Recognition Procedure (IRP) for UK market entry; MedTech Europe and industry bodies have called for EU regulatory oversight of Third-Party Litigation Funding; and an HMA/EMA report focuses on the use of social media data to generate real-world evidence in support of regulatory submissions, among other stories.
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