Notice Information
Notice Title
UK Approved Body for In Vitro Diagnostic (IVD) Devices
Notice Description
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.
Lot Information
Lot 1
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).
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.
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.
Renewal: two optional one-year extensions
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-h6vhtk-041d1b
- Publication Source
- Find A Tender Service
- Latest Notice
- https://www.find-tender.service.gov.uk/Notice/034981-2023
- Current Stage
- Tender
- All Stages
- Tender
Procurement Classification
- Notice Type
- Tender Notice
- Procurement Type
- Standard
- Procurement Category
- Services
- Procurement Method
- Open
- Procurement Method Details
- Open procedure
- Tender Suitability
- Not specified
- Awardee Scale
- Not specified
Common Procurement Vocabulary (CPV)
- CPV Divisions
79 - Business services: law, marketing, consulting, recruitment, printing and security
-
- CPV Codes
79132000 - Certification services
Notice Value(s)
- Tender Value
- £500,000 £500K-£1M
- Lots Value
- Not specified
- Awards Value
- Not specified
- Contracts Value
- Not specified
Notice Dates
- Publication Date
- 27 Nov 20232 years ago
- Submission Deadline
- 10 Jan 2024Expired
- Future Notice Date
- Not specified
- Award Date
- Not specified
- Contract Period
- 1 Feb 2024 - 31 Jan 2027 3-4 years
- Recurrence
- Not specified
Notice Status
- Tender Status
- Active
- Lots Status
- Active
- Awards Status
- Not Specified
- Contracts Status
- Not Specified
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- MHRA/ NIBSC
- Contact Name
- Alison Finn
- Contact Email
- alison.finn@mhra.gov.uk
- Contact Phone
- Not specified
Buyer Location
- Locality
- LONDON
- Postcode
- EN6 3QG
- Post Town
- Enfield
- Country
- England
-
- Major Region (ITL 1)
- TLH East (England)
- Basic Region (ITL 2)
- TLH2 Bedfordshire and Hertfordshire
- Small Region (ITL 3)
- TLH27 South West Hertfordshire
- Delivery Location
- Not specified
-
- Local Authority
- Hertsmere
- Electoral Ward
- Shenley
- Westminster Constituency
- Hertsmere
Further Information
Open Contracting Data Standard (OCDS)
View full OCDS Record for this contracting process
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.
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