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
ECHA’s Biocides Committee supports approval of ethanol in disinfectants ECHA/NR/26/09 The European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC) has concluded that ethanol may be approved for use in hand and general disinfectants. The Committee did not take a position on whether ethanol should be considered a carcinogenic or reprotoxic substance. Helsinki, 24 February 2026 – In its February meeting, the BPC…
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
Dear Members, PackUK have indicated that they have received significantly less money from the fees set of the packaging Extended Producer Responsibility scheme. They’re not looking to recover the difference from producer this year, but will need to make changes to the future running of the scheme, including bringing forward some of the reporting dates. Year 1 Extended Producer Responsibility…
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
The Scottish Environmental Protection Agency Update is covering changes to water regulations and can be read here.
Ben KempFebruary 27, 2026