Law firm, Hogan Lovells, analyses the implications of the AI Act for the Medtech sector and highlight a number of key challenges for medical device manufacturers and their partners in aligning conformity routes for their products under the AI Act.
Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.
Nearly 2/3 of device makers say their regulatory intelligence may be insufficient and they lack the resources to complete all product compliance needs this year. See the executive summary of this MedTech Intelligence audience research.
An analysis from the Life Sciences legal team at Hogan Lovells.
Explore our EU MDR Checklist designed to help you navigate EU MDR compliance. This practical tool guides you through essential steps to adapt your processes and ensure documentation meets regulatory standards. Start your compliance journey with confidence.
As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.
Smridula Hariharan leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas. Here, she shares secrets to cost-effective PMCF strategies in the dynamic landscape of the European Medical Device Regulation (MDR).
FDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR 809.3 to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.”
This European Medicines Agency (EMA) Question & Answer document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations in the context of combinations of medicinal products with medical devices.
San Diego-based medical tech company, Cue Health, announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations.
