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UK Approved Body for In Vitro Diagnostic (IVD) Devices

Certification services
UK
Published value
£500,000
Submission deadline 10 Jan 2024, 12:00 GMT
Lots published1
Procurement Executive Summary
AI & Search Synopsis
Generated from official OCDS record
Tenderline Synopsis: MHRA/ NIBSC: "UK Approved Body for In Vitro Diagnostic (IVD) Devices". Published status: active. Published value: £500,000. 1 published lot. Recorded submission deadline: 10 Jan 2024, 12:00 GMT. See the official notice for participation instructions.
Contracting AuthorityMHRA/ NIBSCScope & CategoriesNot publishedSubmission Window
Closed
10 Jan 2024, 12:00 GMT
Submission GatewayDirect notice routeLegal Basis & RegimeStandard procurementEstimated Value (exc. VAT)£500,000
Bidder Intelligence · Authority Profile: MHRA/ NIBSC
Market Analytics
View Authority Profile →
Derived from OCDS awards & bid statistics
Published history for MHRA/ NIBSC. These figures describe retained records, not a forecast of bids or a measure of buyer bias.
Published-to-award variance
Not availableInsufficient comparable data
Requires at least 5 comparable procedures
Competition Density
2.5Bids / Report
25% of reports have one bid
Supplier ConcentrationNo estimate
Insufficient attributable awardsNo concentration estimate available
Payment Terms
Check noticePublished terms
Payment obligations depend on the applicable regime and contract. Consult the official documents.
Coverage: 4 active published awards; 4 bid reports (which may be per lot). Supplier values exclude multi-supplier awards, frameworks and DPS, and use GBP only. They are published award values, not payments. Published-to-award variance compares single-lot, single-award, single-supplier GBP procedures with explicitly non-framework/non-DPS status; increases remain in the average. Unpublished data stays unknown. Awarded suppliers are winners, not all bidders.
Procedure terms
Contracting AuthorityMHRA/ NIBSC
Procedure methodNot published
Procurement categoryNot published
Statusactive
Framework / DPSNot published
CompetitionNot published
Above thresholdNot published
Legal basisNot published
Tender period startsNot published
Clarification deadlineNot published
Electronic submissionNot published
Submission languagesNot published
Published27 Nov 2023, 17:18 GMT
Last source update27 Nov 2023, 17:18 GMT
Recurring procurementYes
ClassificationCertification services
Delivery area
UK
OCIDocds-h6vhtk-041d1b
What is being bought
The Medicines and Healthcare products Regulatory Agency requires a UK Approved Body that is capable of certifying IVD devices produced by Scientific Research and Innovation that are placed on the GB market.
What changed
From the official release history
  1. Published value updated to £500,000
    27 Nov 2023, 17:18 GMT
  2. Status changed to active
    27 Nov 2023, 17:18 GMT
  3. Official notice release published
    27 Nov 2023, 17:18 GMT
  4. Submission deadline changed to 10 Jan 2024, 12:00 GMT
    27 Nov 2023, 17:18 GMT
  5. Buyer information updated
    27 Nov 2023, 17:18 GMT
Lots and requirements (1)
Published by the contracting authority
  • Lot 1 · #1
    Individual lot title not published
    active
    Published valueNot published
    Scientific Research and Innovation (SR&I) (previously known as NIBSC) is placing In Vitro Diagnostic (IVD) devices on the GB market under EU IVD Directive 98/79/EC using EU Notified Body that issues CE certificates that are currently recognised on the GB market. Since 1 January 2021, there have been a number of changes to Medical Devices Regulations 2002, introduced through secondary legislation - Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, to how medical devices, including IVD devices, are placed on the market in Great Britain (England, Wales and Scotland).<br/>Due to the changes, SR&I must appoint a UK Approved Body that can certify all Annex II List A and B IVD devices produced by SR&I that are placed on the GB market. <br/>This appointment will allow SR&I to continue placing IVD devices on the GB market after transition deadlines and support NHS and NHSBT laboratories and other diagnostic laboratories in safeguarding patients’ health and wellbeing.
    Contract periodNot published
    EligibilityNot published
    Options / renewalNot published
Timeline
  1. Procedure published
    27 Nov 2023, 17:18 GMT
  2. Submission deadline
    10 Jan 2024, 12:00 GMT
Commercial outcome and competition
AwardsNo award published
ContractsNo contract published
Bid statisticsNo aggregate bid statistics published
Buyer and organisations in this procedure

MHRA/ NIBSC

Contracting authority GB-FTS-54745
View buyer profile
Documents (1)
Official links; attachments are not copied

  • technicalSelectionCriteria

    tender
    technicalSelectionCriteria
Related procedures (0)
No data
No related procedures published