The list has now been updated to reflect the expiry of the protocols made under the Medical Devices Regulations 2002. To access the list and the accompanying information, please click here.
Ben KempSeptember 2, 2022
NHS England are currently seeking views on proposed changes to the Clinical genomic service specification. The Service Specification outlines standards for clinical genomic services in England. Some changes to this specification are being considered which NHS England is seeking feedback on. You can find out more information and access the consultation documents here. NHS England is hosting two webinars which…
Ben KempSeptember 2, 2022
The UK Plastics Network are putting on some insightful webinars over the next couple of months. Check the programme below to see if there are any that interest you: Register for Smart Sustainable Plastic Packaging September Workshops: Making Plastics Fit for a Sustainable Future Tuesday 6th September, 09:00 -15:30 | Radisson Blu, Cardiff, Wales Wednesday 7th September, 09:00 -15:30 |…
Ben KempSeptember 2, 2022
When to submit a safety and security declaration for imports into Great Britain has changed. No new import controls will be introduced in 2022. A new target operating model of border controls will be published in Autumn 2022, with an aim to introduce the new rules by the end of 2023. The full guidance document can be accessed here.
Ben KempSeptember 2, 2022
It has been brought to BIVDA’s attention that a framework has recently been issued by Countess of Chester, Commercial Procurement Services with charges being applied. Upon review of the Invitation to tender (ITT) it appears that there will be a Framework Agreement award fee of £5,000, an annual fee of £5,000 and a gain share fee – this will be…
Ben KempSeptember 2, 2022
Novel blood test measures pulmonary arterial hypertension severity The test developed by National Institutes of Health (NIH) researchers, measures DNA fragments released by damaged cells Patients with the disease usually present with high levels of fragments in their blood, with higher levels correlating with disease severity Knowing the fragment levels in patients’ blood allows doctors to tackle the disease faster…
Ben KempSeptember 2, 2022
7 new community diagnostic centres (CDCs) will open to help improve the Covid backlogs, diagnose patients more quickly and meet future demands on the NHS, the Health and Social Care Secretary has confirmed this week. The new CDCs will be rolled out in Willesden and Wembley in north west London, Leigh in Greater Manchester, St Albans, Lancashire, and Eltham in…
Ben KempSeptember 2, 2022
On Thursday, the next phase of the inquiry into the UK’s response to the COVID-19 pandemic began. It will scrutinise decisions made by key players during the pandemic, such as then-Health Secretary Matt Hancock and Prime Minister Boris Johnson. This stage of the process, dubbed Module 2, will centre around government announcements and decisions made between January and March 2020…
Ben KempSeptember 2, 2022
BEIS are putting on a number of webinars to help companies better understand the UKCA regime. This week they announced a special webinar exclusively focused on the regulatory framework relating to UKCA marking for medical devices on Thursday 6 October 2022 at 15:00 – 15:40. This should help businesses to get ready for the new regime as soon as possible…
Ben KempSeptember 2, 2022
The BIVDA Market Audit results are back for the first half of 2022! If your company participates you should now have detailed information on the UK IVD market dynamics down to individual test level at your fingertips. Overall the market seems to have stabilised, with some recovery of non-Covid testing revenues since lockdown. For more information contact John Bagshaw via…
Ben KempSeptember 2, 2022