Skip to main content
search
Category

Membership News

MedTech Europe Updates Regulatory Affairs NewsletterMembership NewsMembership News ArchiveRegulatory Affairs Newsletter

Feedback on EU RoHS exemption pack utilisation

BIVDA and MedTech Europe are gathering information on the EU RoHS (including Northern Ireland), exemption pack renewal for Lead and Mercury in product type 8 – medical devices include those specifically for IVDs. If you rely on the exemption packs for RoHS compliance to place products on the EU and/or Northern Ireland markets, then please let BIVDA know. MedTech Europe…
Ben Kemp
September 3, 2024
Membership NewsMembership News Archive

Access BIVDA Webinar on “Counterfeits and Copyright”

Last week, BIVDA were excited to host our "Counterfeits and Copyright" webinar, where we welcomed the Rachel Jones from SnapDragon Monitoring to talk to members of our Springboard Programme. Rachel provided hints and tips around online monitoring for illicit material and ensuring its quick and efficient removal using intellectual property rather than cumbersome legal processes. Online brand protection is now…
Ben Kemp
September 3, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA launch statutory fees consultation

The MHRA last week launched a consultation on statutory fees proposals for April 2025 until March 2027. Unsurprisingly, the trajectory is upwards - in some cases (such as clinical trials) significantly. BIVDA’s Head of Policy and Programmes, Paul Fisher noted, "These proposed increases will disproportionately impact SMEs - the sector that the government and NHS recognise as a key part…
Ben Kemp
September 3, 2024
Membership NewsMembership News Archive

UKHSA issue request for information regarding available options to test for Mpox from POCT suppliers

UKHSA seek to gather comprehensive information regarding the available options to test for Mpox from the Point of Care Testing suppliers awarded on the new Laboratory Diagnostics, Point of Care Testing & Pathology Managed Services (OJEU REF - 2023/S 000-001309) NHS Supply Chain framework. To aid them in their efforts, please provide detailed insights by responding to this Request For…
Ben Kemp
August 29, 2024
Membership NewsMembership News Archive

Cardiac Marker Dialogues 2024

A reminder that registration is open for Cardiac Marker Dialogues 2024: Cardiac Biomarkers in Real Time - experiences and opportunities. Make sure to book by Friday 30 August to take advantage of the early bird rate. Hosted by UK NEQAS Cardiac Markers, Cardiac Marker Dialogues: Cardiac Biomarkers in Real Time - experiences and opportunities will be held in Glasgow on…
Ben Kemp
August 27, 2024
Membership NewsMembership News Archive

Tony Blair Institute: A New Tool to Map Untapped Health Data

The Tony Blair Institute for Global Change (TBI) has developed a tool which can map where data is generated across the UK’s health system, helping to guide efficiencies and uncover areas for discussion and development. The organisation has long called for improved utilisation of health data to make the NHS a more efficient and dynamic health service. The full data-architecture…
Ben Kemp
August 27, 2024
Membership NewsMembership News Archive

Innovate UK host final session of UK-India Healthcare Trade Mission 2024

BIVDA's Paul Fisher supported an Innovate UK Trade Mission workshop, which focussed on AMR diagnostics and therapeutics. Throughout 2024, Innovate UK have hosted their Global Business Innovation Programme for Antimicrobial Resistance. This initiative is aimed at businesses that focus on diagnostics and therapeutics within the area of AMR. The programme consisted of three phases; a “Get Ready” workshop, a one-week…
Ben Kemp
August 27, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Common specifications for IVDs for parasites, viruses proposed by European Commission

The European Commission has suggested revising the common specifications for certain class D in vitro diagnostic devices to address tests for specific parasites and viruses of public health importance. Stakeholders have a four-week period to provide feedback on these proposed changes. On 19 August, the Commission released the proposed amendments, which, if approved, would update the In Vitro Diagnostic Medical…
Ben Kemp
August 27, 2024
Membership NewsMembership News Archive

Apply to join NICE’s Technology Appraisal Committee

The Technology Appraisal committees look at innovative technologies (such as CAR-T in oncology), technologies that have the potential to improve the health of a large number of people (such as inclisiran in cardiovascular disease) or make a meaningful difference to people with very severe disease (such as risdiplam in spinal muscular atrophy).  NICE are seeking members to join the Technology Appraisal Committee (TAC), in the…
Ben Kemp
August 23, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA AI Airlock Webinar from July 2024 available

The MHRA have uploaded their webinar covering the AI Airlock from July, which may be of interest to members. The webinar provides a helpful overview of the utilisation of the Airlock for the development of AI IVDs. It can be accessed here.
Ben Kemp
August 23, 2024
Close Menu