Section one: Contracting authority
one.1) Name and addresses
MHRA/ NIBSC
EN6 3QG
London
EN6 3QG
Contact
Alison Finn
Country
United Kingdom
Region code
UK - United Kingdom
National registration number
MHRA Buyer Organisation
Internet address(es)
Main address
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Buyer's address
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://health-family.force.com/s/Welcome
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://health-family.force.com/s/Welcome
Tenders or requests to participate must be submitted to the above-mentioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
https://health-family.force.com/s/Welcome
one.4) Type of the contracting authority
Ministry or any other national or federal authority
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
UK Approved Body for In Vitro Diagnostic (IVD) Devices
Reference number
C171048
two.1.2) Main CPV code
- 79132000 - Certification services
two.1.3) Type of contract
Services
two.1.4) Short 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.
two.1.5) Estimated total value
Value excluding VAT: £500,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
two.2.4) Description of the procurement
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.
two.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Start date
1 February 2024
End date
31 January 2027
This contract is subject to renewal
Yes
Description of renewals
two optional one-year extensions
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers
List and brief description of conditions
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
three.1.3) Technical and professional ability
Selection criteria as stated in the procurement documents
three.2) Conditions related to the contract
three.2.2) Contract performance conditions
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
10 January 2024
Local time
12:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.6) Minimum time frame during which the tenderer must maintain the tender
Duration in months: 2 (from the date stated for receipt of tender)
four.2.7) Conditions for opening of tenders
Date
10 January 2024
Local time
12:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: Yes
six.4) Procedures for review
six.4.1) Review body
High Court
39 Victoria Street
London
SW1H 0EU
Country
United Kingdom
Internet address
https://www.gov.uk/government/organisations/department-of-health-and-social-care
six.4.2) Body responsible for mediation procedures
High Court
39 Victoria Street
London
SW1H 0EU
Country
United Kingdom
Internet address
https://www.gov.uk/government/organisations/department-of-health-and-social-care