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AstraZeneca opens The Discovery Centre in Cambridge

The move will bolster AstraZeneca’s efforts to develop cutting-edge therapeutics, such as nucleotide-based gene-editing and cell therapies, and support their focus on specialised and precision medicines. The company hopes that the unveiling marks a new wave of scientific innovation for the UK. It also puts the UK’s world-class life sciences cluster in Cambridge, which generates almost £3 billion annually to…
admin
November 26, 2021
Membership NewsMembership News ArchiveProcurement Working PartyProcurement Working Party Archive

BIVDA is pleased to announce a working partnership with IntelliCentrics UK

This partnership is a sector leading initiative, intended to simplify the process which is becoming increasingly prominent in Trusts. Working closely with NHS and Private hospitals through Intellicentrics, BIVDA will be able to support members to conduct their business in customer accounts with appropriate entry criteria relative to the job roles they perform, Credentialling is important for hospitals and patients…
admin
November 26, 2021
Membership NewsMembership News Archive

BIVDA response submitted to MHRA UKCA consultation

The consolidated BIVDA response to the MHRA consultation on the future regulation of medical devices in the United Kingdom was submitted on 25 November. This was a full response to all sections relevant to IVDs, and was based on feedback provided by members. BIVDA have also drafted a cover letter to be provided to MHRA separately, supplementing the information provided…
admin
November 26, 2021
HighlightsHighlights Archive

Health and Care Bill passes House of Commons stages

The Health and Care Bill went through its remaining stages in the House of Commons this week. Amendments were made to the Bill regarding some of the following areas: the workforce in the health service or related sectors, cosmetic procedures, virginity testing or hymenoplasty, and clauses relating to the Health Services Safety Investigations Body. Branding of e-cigarettes was also debated…
admin
November 26, 2021
AMR TaskforceAMR Taskforce ArchiveConsultations Archive

UK Health Security Agency – sepsis consultation

Closing: 29/11/2021 New Consultation: UK SMI S 12: sepsis and other systemic and disseminated infections | See here BIVDA is seeking company input members of the AMR working party to respond on behalf of the sector. Please send your comments to Ashleigh no later than Wednesday 24 November COB. Please register for a Ad-Hoc AMR consultation response meeting with Doris-Ann…
admin
November 19, 2021
Consultations ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Consultation on specific IVD related GMDN terms

The GMDN Agency have provided the summary information below. This is regarding a consultation on specific IVD related GMDN terms. The IVD Team at the GMDN Agency have launched a consultation regarding a proposed scaling back of antibody-specific IVD terms within the GMDN. The move would be to consolidate all infectious disease antibody-class specific terms for a particular analyte to…
admin
November 19, 2021
Consultations Archive

MHRA Consultation on the UK’s future medical device regulatory regime

The MHRA has launched the public consultation on the future medical devices regime, with survey responses requested from industry stakeholders. BIVDA’s Regulatory Affairs Working Party has a sub-group dedicated to UKCA matters and will be working on an industry response to the consultation. Members are advised to submit their own responses independently as a priority. The consultation closes at 11:45pm…
admin
November 16, 2021
Membership NewsMembership News Archive

Mandatory Validation of Covid-19 Tests – Industry Update

Applicants who submitted an application prior to the 31st August 2021, were expecting to continue to provide their tests to market until 31st October pending the approval by CDTA under The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (legislation.gov.uk) CDTA were unable to conclude approvals within this time frame, and whilst in some cases, the quality of applicant’s…
admin
November 5, 2021
Membership NewsMembership News Archive

MHRA consultation on new Regulations

BIVDA are in the process of formulating our response to the ongoing MHRA consultation on the new Regulatory framework for medical devices and IVDs in the UK. This will ultimately be channelled through the UKCA Working Group (initially created as an extension of the Regulatory Affairs Working Party). We fully appreciate that there may be a number of members who…
admin
November 5, 2021
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