Europe – Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices...
USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR...
The Department of Health and Human Services (HHS) recently published the fall 2023 unified agenda for the US Food and Drug Administration (FDA) that...
USA – Combination products: FDA experts address UDI, harmonization, OPQ reorganization
Officials from the US Food and Drug Administration (FDA) fielded wide-ranging questions on the development and marketing of combination products — from UDI requirements...
France – Conception orientée production : que faire pour les DM les plus complexes...
Creative Eurecom est un bureau de R&D qui présente la particularité de faire cohabiter mécanique, électronique, fluidique et logiciel dans des produits destinés à être...
USA – Device cybersecurity must be a priority from design through retirement, experts say
Cybersecurity must be a priority for any medical device that connects to the internet, from its earliest design phase to the end of its...
Europe – MDCG raises alarm over lack of MDR, IVDR applications
The European Commission’s Medical Device Coordination Group (MDCG) is telling medtech manufacturers to get certified under the new device and diagnostics regulations as soon...
USA – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
France – Conformité du marquage UDI : la norme ISO sur les Data Matrix...
Rappelons en préambule que pour procéder au contrôle de conformité d’un code Data Matrix, une ‘’douchette’’ ne suffit pas. On effectue ce contrôle au...
USA – TCET pathway may broaden access to breakthrough devices, but reforms still needed
While the Transitional Coverage for Emerging Technologies (TCET) pathway proposed by the Centers for Medicare and Medicaid Services (CMS) offers the potential to speed...
USA – Existing software development lifecycle tools can help speed AI/ML products to market
Software developers creating artificial intelligence/machine learning (AI/ML) medical products should move forward with the software development lifecycle (SDLC) models they are already familiar with...
