Official UK procurement notice
UK Approved Body for In Vitro Diagnostic (IVD) Devices
Authority: MHRA/NIBSC
What is being bought
Published requirement descriptionThe 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.
CPV: Certification services
The lotProcurement structure
single lot · no lot value publishedLot #1Scientific Research and Innovation (SR&I) (previously known as NIBSC) is placing In…Renewal
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.
What it takes to wini
How this buyer will score bids.
The evaluation criteria and weights exactly as published on the notice, grouped by family (price, quality, social value and so on).
Evaluation split and conditions of participation as published; the tender pack may add morei
How this buyer will score bids.
The evaluation criteria and weights exactly as published on the notice, grouped by family (price, quality, social value and so on).
- Suitability
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Procedure terms & legal framework
From the official record- Procedure method
- Open procedure
- Legal basis
- CELEX · 32014L0024 Public Contracts Regulations 2015 (Directive 2014/24/EU)
- Procurement category
- Services
- Notice status
- Closed
- Procurement threshold
- Unspecified in notice
- Regulatory regime
- Standard
- Commercial structure
- Stand-alone contract (no framework)
- Competition type
- Competitive procedure
- GPA / WTO covered
- Yes (GPA)
- Recurring procurement
- Yes
- First published
- 27 Nov 2023, 17:18 GMT
- Last source update
- 27 Nov 2023, 17:18 GMT
- Award evaluation window
- 10 Jan 2024 – …
- Authority reference
C171048- FTS notice number
2023/S 000-034981- Classification (CPV)
- Delivery area
- Official registry OCID
ocds-h6vhtk-041d1bFind a Tender
- Performance terms
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
How it was run
Official noticeTender documents are also served through a separate tool: https://health-family.force.com/s/Welcome ↗
- Submission deadline
- 10 Jan 2024, 12:00 GMT
- Submission channel
- {"electronicSubmission","written"}
- Accepted languages
- en
- Bid validity
- 60 days from the deadline
- Bids opened
- 10 Jan 2024, 12:00 GMT
Timeline
27 Nov 2023 → 1 Feb 2024 · 4 dates- Notice published27 Nov 2023, 17:18 GMT
- Submission deadline10 Jan 2024, 12:00 GMT
- Bids opened10 Jan 2024, 12:00 GMT
- Contract starts1 Feb 2024
Contracting authority & participating public bodies
Dispute resolution & review bodies
- High CourtMediation bodyReview body
Official documents & specifications (1)
Official links; attachments are not copiedTender pack and attachments
- Technical selection criteria