Contract notice
Section I: Contracting
authority
I.1) Name and addresses
MHRA/ NIBSC
MHRA Buyer Organisation
EN6 3QG
London
EN6 3QG
UK
Contact person: Alison Finn
E-mail: Alison.finn@mhra.gov.uk
NUTS: UK
Internet address(es)
Main address: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Address of the buyer profile: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
I.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 abovementioned address
Tenders or requests to participate must be sent electronically to:
https://health-family.force.com/s/Welcome
Tenders or requests to participate must be sent to the abovementioned 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
I.4) Type of the contracting authority
Ministry or any other national or federal authority, including their regional or local subdivisions
I.5) Main activity
Health
Section II: Object
II.1) Scope of the procurement
II.1.1) Title
UK Approved Body for In Vitro Diagnostic (IVD) Devices
Reference number: C171048
II.1.2) Main CPV code
79132000
II.1.3) Type of contract
Services
II.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.
II.1.5) Estimated total value
Value excluding VAT:
500 000.00
GBP
II.1.6) Information about lots
This contract is divided into lots:
No
II.2) Description
II.2.3) Place of performance
NUTS code:
UK
II.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).<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.
II.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Start:
01/02/2024
End:
31/01/2027
This contract is subject to renewal: Yes
Description of renewals:
two optional one-year extensions
II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted:
No
II.2.11) Information about options
Options:
No
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
No
Section III: Legal, economic, financial and technical information
III.1) Conditions for participation
III.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).
III.1.3) Technical and professional ability
Selection criteria as stated in the procurement documents
III.2) Conditions related to the contract
III.2.2) Contract performance conditions
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Section IV: Procedure
IV.1) Description
IV.1.1) Type of procedure
Open procedure
IV.1.8) Information about Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement:
Yes
IV.2) Administrative information
IV.2.2) Time limit for receipt of tenders or requests to participate
Date:
10/01/2024
Local time: 12:00
IV.2.4) Languages in which tenders or requests to participate may be submitted
EN
IV.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)
IV.2.7) Conditions for opening of tenders
Date:
10/01/2024
Local time: 12:00
Section VI: Complementary information
VI.1) Information about recurrence
This is a recurrent procurement:
Yes
VI.4) Procedures for review
VI.4.1) Review body
High Court
39 Victoria Street
London
SW1H 0EU
UK
Internet address(es)
URL: https://www.gov.uk/government/organisations/department-of-health-and-social-care
VI.4.2) Body responsible for mediation procedures
High Court
39 Victoria Street
London
SW1H 0EU
UK
Internet address(es)
URL: https://www.gov.uk/government/organisations/department-of-health-and-social-care
VI.5) Date of dispatch of this notice
27/11/2023