Dear members, MedTech Europe have provided an update below on the latest chemical developments at ECHA. Please note that Ethylene Oxide has been declined as an active substance under the Biocides regulation for PT 2, however use of Ethylene Oxide to sterilise medical devices within the scope of EU MDR means that the use of Ethylene Oxide can continue as…
Ben KempJune 18, 2025
Following a review with members around the content and scope of the Environmental Working Party, BIVDA are going to change its name to better reflect what this working group covers. Being called 'Environmental' has been misleading and is often assumed to relate to sustainability or tenders, when this is not the case. This working party will now be called “Chemicals…
Ben KempJune 18, 2025
“Value” to feature in NHS 10 Year Plan as whole system set to be “revitalised” It is expected that procurement and the importance of value will be referenced in the Government’s 10 Year Plan for the National Health Service (NHS) in England. Publication of the Plan is anticipated for early July, and it will reflect the determination of health…
Ben KempJune 18, 2025
Following evidence sessions, Parliament's Public Accounts Committee has released their report into the risks of antimicrobial resistance (AMR). The committee is a cross-party group of MPs who scrutinises the value for money of Government projects, programmes and service delivery. The report highlights that there remains an "insufficient use of diagnostic tools to support the use of antimicrobials". It criticises the…
Ben KempJune 17, 2025
The NHS has announced that more accurate human papillomavirus (HPV) testing will enable millions of women in England to benefit from more personalised cervical screening from next month. From July, younger women (aged 25 to 49) who test negative for HPV, meaning they are at very low risk of cervical cancer over the next 10 years, will safely be invited…
Ben KempJune 17, 2025
BIVDA is pleased to inform members that James Barker (Cytocell) has accepted the post of co-chair of the UKCA Subgroup. James will work alongside the existing chair, Emma Barringer. James is a regulatory professional with almost 20 years of experience in the IVD sector, currently serving as Regulatory Affairs Manager at Oxford Gene Technology (OGT) in Cambridge, UK. Over the…
Ben KempJune 17, 2025
A new initiative aimed at assessing a blood test for the early detection of pancreatic cancer is now recruiting participants. The Safe-D study, taking place in Southampton is enrolling individuals with type 2 diabetes — a condition linked to an increased risk of developing pancreatic cancer. It is supported by Wessex Health Partners, a regional partnership bringing together Integrated Care…
Ben KempJune 17, 2025
The next Genomics Working Party meeting will take place next week on Tuesday 24th June at 10:30am - 13:30pm and will be held online. The working party will be broken up into three Task and Finish groups with each having their own online meeting link. The groups are focused on the following topics: Establishing more efficient pathways for new technologies…
Ben KempJune 17, 2025
From the 16th June 2025, new legal requirements for monitoring the safety of medical devices take effect, as part of the MHRA's broader transformation of the UK’s medical device regulatory framework. The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. The reform applies to all UKCA- and CE-marked devices placed on…
Ben KempJune 17, 2025