New Publication! Strengthen Tumor Market Testing with CLSI C65 Biochemical tumor marker plays a critical role in diagnosis, monitoring, and clinical decision making. With increasing pressure on laboratories to ensure accuracy and consistency across preexamination, examination, and postexamination processes, the new CLSI C65 standard provides the guidance needed to reduce risk and improve confidence in patient results. Practical…
Ben KempMarch 2, 2026
Dear Members, Team NB have published their position paper on the demonstration of safety and performance for combinational Use of Reagent Devices with other Equipment Team-NB Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other devices or Equipment - team-nb
Ben KempMarch 2, 2026
Register medical devices to place on the market Page summary: How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland. Change made: Changes to registration requirements for Northern Ireland effective 28 May 2026Updated Fees implementation guidance; clarification concerning fee waivers and new section for Northern Ireland feesIVDs undergoing performance evaluation; minor updates…
Ben KempFebruary 27, 2026
The EC currently has an open survey on EUDAMED preparedness. MedTech Europe have highlighted the absence of adequate documents in the following areas. If you would like to respond to the EC survey, please see the link below, and the list of items that MedTech Europe has identified, but could do with other survey respondents also highlighting. Should you wish…
Ben KempFebruary 27, 2026
📣 EU funding available for health research - check out the open calls for proposals under #HorizonEU! https://lnkd.in/erHNvAQa 🗓️ Deadline: 16 April
Ben KempFebruary 27, 2026
Dear Members, TGA Australia have issued New resources on market actions and minor PRAC updates We have published a new FAQ and Guidance page on the use of legislative powers related to recalls and other market actions. View article...
Ben KempFebruary 27, 2026
Dear Members, TGA Australia have issued an update on use of legislative powers related to recalls and other market actions Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions. View article...
Ben KempFebruary 27, 2026
MHRA - Update to PARD: product brand names now available: https://pard.mhra.gov.uk/
Ben KempFebruary 27, 2026