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
PFAS (Poly Fluro Akyl Substances), are a group of 10,000+ substances often used as precursors in chemical processes, or because of their technical properties. They’re non-stick, stain resistant, water repellent, low friction, and highly durable and chemically inert, however, they’re ‘forever chemicals’ that either don’t break down or break down into ‘forever’ chemicals that persist in the environment. Some have…
Ben KempSeptember 18, 2024
Your company may have recently received an invitation from various NHS Trusts to join the Achilles platform. This initiative is being piloted by Crown Commercial Services (CCS) as a potential tool for capturing supplier Environmental, Social, and Governance (ESG) data. However, the MedTech Forum have identified concerns about significant overlap between Achilles and existing platforms used by the NHS, such…
Ben KempAugust 27, 2024
It is bittersweet to let you all know that I will be leaving my role as Head of Regulatory Affairs at BIVDA, with my last working day being 25 August. I have loved my time working with the BIVDA secretariat and the BIVDA membership, and I’m sure I will cross paths with many of you again in the future!…
DawnJune 30, 2023
There is work ongoing within MedTech Europe on labelling of medical devices. To support in this work, MedTech Europe have requested the following information from industry by 28 April. Data on financial impact of additional labelling requirements arising from any jurisdiction. Costs of label development/production per major jurisdiction are welcome (e.g. to prepare a specific label for certain region/country; percentage of…
adminApril 21, 2023
The Seminar covered the following topics: MHRA Software Roadmap with Johan Ordish (MHRA) MHRA IVD Roadmap, UKCA, and the Life Science Review with Ashleigh Batchen (BIVDA), Tom Beale (Agilent Technologies) and Camilla Fleetcroft MDCG Roadmap with Andrew Rutter (QuidelOrtho) Class D IVDs with Erica Conway (MCRA) BSI Standards with Rob Turpin (BSI) US Regulatory Process Stuart Angell (IVDeology) The event…
adminMarch 24, 2023