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.
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.
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.
The common theme illustrated in a recent survey among medical device regulatory professionals is the need for increased resources, expertise, and technology. The data validates industry concerns of increasing workloads and overtime hours, and how many companies are finding it hard to recruit suitable skilled regulatory associates. Medical device company RA/QA teams raise concern about deficient competencies and resource availability with increasing regulatory complexity and changing global requirements.
An analysis from the Life Sciences legal team at Hogan Lovells.
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.
