The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has developed a discussion paper, Health Equity For Medical Devices, and seeks input from the public on advancing health equity on the context of medical devices.
Q2/24 Life Science and Health Care Law Updates by Hogan Lovells including key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) regulatory, corporate, compliance, competition, and privacy.
nsuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key frameworks play a crucial role: ISO 14971:2019 and the FDA Quality Management System Regulation (QMSR). This essay explores their individual contributions and how they work synergistically to enhance medical device safety.
Navigating the conformity assessment process – examination of a manufacturer’s technical documentation and quality management system – requires a thorough understanding of the different routes and options available for various risk classifications of medical devices and IVDs, while knowledge of the conformity assessment process helps manufacturers prepare effectively and manage expectations. This blog offers guidance for creating successful conformity assessments.
Light field technology is illuminating a path to a deeper understanding of patient anatomy, surgeon methodology, and surgical environments. Traditionally, spine surgery navigation has depended on surgeons combining pre-operative imaging with intra-operative anatomy to execute their treatment plans. However, with light field technology and depth sensors, these technologies digitize the entire operative field, merging it seamlessly with preoperative imaging, effectively bridging the gap between unseen and visible physical anatomy of the spine. This provides surgeons with a three-dimensional anatomical view that exceeds what the naked eye can discern.
As medical technology products and services move through the development pipeline, they face the challenge of both showing safety and efficacy for regulatory approval and articulating the value of the diagnostic, treatment or monitoring technology to obtain reimbursement from payers. A 2024 MedExec Women Conference panel highlighted strategies to bridge the evidence needs for regulatory approval and reimbursement to more efficiently bring products to market.
Law firm, Hogan Lovells, analyzes the changes to the updated enforcement policy and provide key takeaways for entities responsible for communication regarding approved/cleared medical products.
Cevian Capital increased its position in Smith & Nephew to a 5% stake in the British medical equipment maker, making it Smith & Nephew’s second largest shareholder according to reports by Reuters.
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.
