UK Approved Body for In Vitro Diagnostic (IVD) Devices (Ангилья - Тендер #48592230)

• 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

Information added to the notice since publication.

Additional information added to the notice since it"s publication. Commodity Categories Commodity Categories
Delivery Locations Delivery Locations
Alert Region Restrictions

The buyer has restricted the alert for this notice to suppliers based in the following regions.

Alert Region Restrictions

Источник закупки

Перейти

Импорт - Экспорт по стране Ангилья