Updated CLSI Guidance EP 31 Ed 2 issued, US focused, but used internationally, on end-user evaluation of comparability of results within one health system, published 25th September 2025.
Ben KempOctober 2, 2025
Includes a number of the larger Diagnostic companies in the list. Although not applicable to the SMEs or even some of the larger businesses, again these businesses will find that if they’re suppliers to the bigger companies then they’ll still be asked for their emissions etc. so the bigger businesses can do their own reporting. California Releases List of More…
Ben KempOctober 2, 2025
Note that although IVDs are typically not themselves subject to restrictions under sanctions unless possibly considered to be dual use, or contain cryptography technology to encrypt patient data (in which case export licences are required). Some organisations offering services related to export or finance maybe restricted or be reluctant to be involved in exports to sanctioned countries. E.g. legal services…
Ben KempOctober 2, 2025
UK NEQAS is holding a six-part pan-disciplinary webinar series Quality Standards in Point of Care Testing. The second webinar will take place on 1 October 2025 and registration is now open at https://us06web.zoom.us/webinar/register/WN_a1-uMaqNThitDqJ0F-k1OA The webinar will include the following presentations – Professor Peter L. Chiodini Malaria Antigen Rapid Diagnostic Tests, what a dipstick! With apologies to "Only Fools and Horses”…
Ben KempSeptember 25, 2025
The Customs (Tariff and Miscellaneous Amendments) (No. 3) Regulations 2024 Regulation 2 amends the definition of “the authorised use document” in regulation 32(2) of the Customs (Special Procedures and Outward Processing) (EU Exit) Regulations 2018 (S.I. 2018/1249) to refer to a new version of that document. The new version of this document removes one commodity code to align with changes…
Ben KempSeptember 22, 2025
Reforming domestic CITES implementation Page summary: Seeking views on regulatory reforms to the implementation of CITES domestically. Change made: First published.
Ben KempSeptember 22, 2025
Health Canada and the Public Health Agency of Canada have conducted a broad review of regulations and program administration to identify outdated, inefficient or duplicate regulations that hinder economic growth and create unnecessary burden for businesses and people in Canada. View article...
Ben KempSeptember 12, 2025
The new technical report CLC/TR 50734:2025 - Application of EMF standards to combined products - can be found here.
Ben KempSeptember 12, 2025
CLSI have published Guidance POCT16 | Emergency and Disaster Point-of-Care Testing. It is US focused, but may be useful.
Ben KempSeptember 12, 2025
Standard for conducting LCAs for Electrical and Electronic Equipment. Not sure if there is work ongoing separately for a MD or IVD LCA. EN IEC 63366:2025 - Product category rules for life cycle assessment of electrical and electronic products and systems (publication date=2025-08-01) View article...
Ben KempSeptember 8, 2025