Latest UKCA extensions do not apply to medical devices Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Latest UKCA extensions do not apply to medical devices

This includes: The General Product Safety Regulations 2005 Supply of Machinery (Safety) Regulations 2008 Electromagnetic Compatibility Regulations 2016 Pressure Equipment Safety Regulations 2016 Electrical Equipment (Safety) Regulations 2016 Simple Pressure Vessels (Safety) Regulations 2016 Radio Equipment Regulations 2017 These timelines have been extended for 12 months to allow extra time for compliance. Importantly, these timeline changes do not impact medical…
Natalie Creaney
November 18, 2022
Department for Business, Energy & Industrial Strategy (BEIS) Announcement on UKCA Marking (Non-Medical Devices) – Further Webinar Dates Announced Member RequestsMember Requests Archive

Department for Business, Energy & Industrial Strategy (BEIS) Announcement on UKCA Marking (Non-Medical Devices) – Further Webinar Dates Announced

Following on from the BEIS announcement to introduce legislation to continue recognition of the CE marking and reversed epsilon marking until 31 December 2024, a further two webinars will be held on Monday 21 November 2022 for anyone unable to attend the previous webinar session on Wednesday 16 November. Please find the registration links below to register for either of…
Natalie Creaney
November 18, 2022
BIVDA featured in MedTech Insight Member RequestsMember Requests Archive

BIVDA featured in MedTech Insight

Doris-Ann was quoted in MedTech Insight in an article which examined genomic testing access in the UK. The publication concluded that there was still much work to be done within the NHS to fully take advantage of genomic testing – pointing squarely at an ABPI report which suggests several recommendations. They also suggested that the UK can learn much from…
Natalie Creaney
November 18, 2022
Scottish One Health Antimicrobial Use and Antimicrobial Resistance in 2021 report Infectious Diseases Working PartyInfectious Diseases Working Party ArchiveMember RequestsMember Requests Archive

Scottish One Health Antimicrobial Use and Antimicrobial Resistance in 2021 report

Scottish One Health Antimicrobial Use and Antimicrobial Resistance (SONAAR) in 2021 report has produced a series of findings which may be of interest to members. Notable statistics include: Total antibiotic use in humans has decreased by 16.9% in Scotland since 2017 and have decreased by 8.6% in acute hospitals since 2017. Members can read the full report and the report…
Natalie Creaney
November 18, 2022
NHSSC Pathology Retender – Draft Evaluated Line List Member RequestsMember Requests Archive

NHSSC Pathology Retender – Draft Evaluated Line List

NHS Supply Chain have released their drafted evaluated line list for Lots 2-7. These are the products that will make up the financial evaluation and therefore suppliers are asked to check there is at least 1 item in each lot you intend to bid on that you can submit a product against. If there is no product specification that you…
Natalie Creaney
November 18, 2022
Update on Category Management Service Providers – Medical Consumables Categories Procurement Working PartyProcurement Working Party Archive

Update on Category Management Service Providers – Medical Consumables Categories

Please find the below communication from NHS Supply Chain: Dear Supplier, As you may know, NHS Supply Chain is currently evolving the design of its Target Operating Model and as part of the procurement process, we are looking to change our service provider model by implementing a new category management service with five distinct categories. We have previously announced that…
Natalie Creaney
November 18, 2022
Media Monitoring: 12th – 18th November HighlightsHighlights Archive

Media Monitoring: 12th – 18th November

Detecting the undetected: measuring levels of three proteins in the blood can aid detection of undiagnosed prediabetes New research has identified a three-protein signature in the blood that can improve detection of impaired glucose tolerance, a form of prediabetes Their results also indicate that fasting before the blood sample is taken does not significantly change the reliability of the three-protein…
Natalie Creaney
November 18, 2022
Health Secretary makes first major speech in post HighlightsHighlights Archive

Health Secretary makes first major speech in post

The Health and Social Care Secretary Steve Barclay MP delivered his first major speech in post to the NHS Providers annual conference on Wednesday. The speech aimed to set the tone of Mr Barclay’s leadership of DHSC as well as provide more details about his priorities going forward. Mr Barclay clearly wanted to dispel any myths that he would be…
Natalie Creaney
November 18, 2022
Chancellor delivers his Autumn Statement: BIVDA Analysis HighlightsHighlights Archive

Chancellor delivers his Autumn Statement: BIVDA Analysis

On Thursday, the Chancellor Jeremy Hunt delivered his much-awaited Autumn Statement aimed at calming the markets and setting the UK on a more sustainable course following a year of global and domestic chaos. In this piece, we will examine the key areas which affect the IVD industry going forward. Evidently, while the overall theme of the statement was that of…
Natalie Creaney
November 18, 2022