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Hysbysiad o Gontract

MEDICAL TECHNOLOLGY (MEDTECH) INNOVATION DPS

  • Cyhoeddwyd gyntaf: 05 Ionawr 2024
  • Wedi'i addasu ddiwethaf: 05 Ionawr 2024
  • Fersiwn: N/A
  •  

  • Efallai na fydd y ffeil hon yn gwbl hygyrch.

  •  

Eicon Gwybodaeth

Nid yw'r prynwr yn defnyddio'r wefan hon i weinyddu'r hysbysiad.

I gofnodi eich diddordeb neu gael gwybodaeth neu ddogfennau ychwanegol, darllenwch y cyfarwyddiadau yn Nhestun Llawn yr Hysbysiad. (NODER: Nid oes angen ymateb i Hysbysiadau Dyfarnu Contractau a Hysbysiadau Gwybodaeth Ymlaen Llaw fel arfer)

Cynnwys

Crynodeb

OCID:
ocds-h6vhtk-042a6d
Cyhoeddwyd gan:
NHS Supply Chain
ID Awudurdod:
AA21880
Dyddiad cyhoeddi:
05 Ionawr 2024
Dyddiad Cau:
02 Ionawr 2031
Math o hysbysiad:
Hysbysiad o Gontract
Mae ganddo ddogfennau:
Nac Ydi
Wedi SPD:
Nac Ydi
Mae ganddo gynllun lleihau carbon:
AMH

Crynodeb

There are criteria detailed within the tenders documentation around Compliance/Validation stage that is required to participate within this Innovation MedTech DPs that are a Pass/Fail Requirements.

- URN Reference number provided by NHS Innovation service portal, HIN health innovation network or NHS SC Innovation Team where applicable for the following:

- Innovation Service OR

- National policy from NHSE or DHSC OR

- NICE Guidance

AND

- MHRA Product Registration

The following certification will be a requirement of the upcoming tender exercise and Applicants will be required to include evidence of this within their tender submission.

- ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the Applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage, distribution and customer service. Further information in respect of certification requirements will be set out in the notice for the forthcoming procurement. If such certificates are not in the name of the Applicant then the Applicant must supply a copy of agreements setting out the authority and responsibilities of all parties in the supply chain and provide evidence of ISO9001:2015 or equivalent for all relevant parties in the supply chain.

- Employers Liability Insurance cover of £5m per claim in the name of the Applicant

- Public Liability Insurance cover of £5m per claim in the name of the Applicant

- Product Liability Insurance cover in the name of the Applicant of £5m per claim or £5m in the annual aggregate

- Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device

Regulations 2002 or Declaration of Conformity and CE Certification to d-Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device Regulations 2002 or Declaration of Conformity and CE Certification to demonstrate compliance to Medical Devices Directive 93/42/EEC or Medical Device Regulation 2017/745 (where applicable).

The NHS has adopted PPN 06/20 (taking account of Social Value), and therefore this future DPS Agreement will include some qualitative evaluation questions on Social Value with a pass/Fail requirement. For more information please see: https://www.gov.uk/government/publications/procurement-policy-note-0620-taking-account-of-social-value-in-the-award-of-central-government-contracts. In addition, from April 2023: the NHS adopted the Government’s ‘Taking Account of Carbon Reduction Plans‘(PPN 06/21) requiring all suppliers with new contracts for goods, services, and/or works with an anticipated contract value above £5 million per annum, to publish a carbon reduction plan for their direct emissions. From April 2024, the NHS will expand this requirement for all new contracts, irrespective of value. Suppliers bidding on NHS Supply Chain tenders will also be required to submit an Evergreen Assessment, please see https://www.england.nhs.uk/nhs-commercial/central-commercial-function-ccf/evergreen/. PPN02/23 "Tackling Modern Slavery in Government Supply Chains" will also apply.

Testun llawn y rhybydd

Hysbysiad contract

Adran I: Endid contractio

I.1) Enw a chyfeiriad

NHS Supply Chain

Wellington House, 133-155 Waterloo Road

London

SE1 8UG

UK

E-bost: Kayla.Richardson@supplychain.nhs.uk

NUTS: UKI4

Cyfeiriad(au) rhyngrwyd

Prif gyfeiriad: https://www.gov.uk/government/organisations/department-of-health

I.2) Caffael ar y cyd

Caiff y contract ei ddyfarnu gan gorff prynu canolog

I.3) Cyfathrebu

Mae'r dogfennau caffael ar gael ar gyfer mynediad uniongyrchol anghyfyngedig a llawn, yn rhad ac am ddim ar:

https://nhssupplychain.app.jaggaer.com//


Gellir cael gwybodaeth ychwanegol o'r cyfeiriad uchod


Rhaid anfon tendrau neu geisiadau i gymryd rhan yn electronig at:

https://nhssupplychain.app.jaggaer.com//


Rhaid anfon tendrau neu geisiadau i gymryd rhan i'r cyfeiriad uchod:


I.4) Y math o awdurdod contractio

Asiantaeth/swyddfa genedlaethol neu ffederal

I.5) Prif weithgaredd

Iechyd

Adran II: Gwrthrych

II.1) Cwmpas y caffaeliad

II.1.1) Teitl

MEDICAL TECHNOLOLGY (MEDTECH) INNOVATION DPS

II.1.2) Prif god CPV

33100000

 

II.1.3) Y math o gontract

Cyflenwadau

II.1.4) Disgrifiad byr

Supply Chain Coordination Ltd (the “authority or NHS Supply Chain”) is issuing this Invitation to Tender (“ITT”) in to establishing Dynamic Purchasing System (DPS).

Offer a route to market for Innovative products (Novel or iterative and meets an unmet need or provides improvements upon existing models of care with the end-goal of benefiting the system, patients and/or care providers)

The objectives of this contract are to:

Enable customer access to Medical Technology (MedTech) products and associated services that would not normally be available and that are of an innovative nature that they cannot be range extended on to a traditional Framework Agreements.

Provide a compliant route to the NHS market for innovative and game changing MedTech products, reducing the barriers to entry and the time to market. Whilst still maintaining patient safety and improving patient care.

Enable early access to innovative technology and regulatory approved products which enhance treatment solution for NHS patients.

Maintain a compliant route to market for the Trusts bringing innovation products to the market sooner.

Improve patient outcomes.

Category area covered by this DPS:

- Orthopaedics, Trauma and Spine

- Ophthalmology

- Audiology

- Cardiology

- Endourology

- Endoscopy

- Neuromodulation

- Oncology Ablation

- Minimally Invasive Surgery

- IVDR products/ tests (Pathology and Point of Care)

II.1.5) Cyfanswm gwerth amcangyfrifedig

Gwerth heb gynnwys TAW: 500 000 000.00 GBP

II.1.6) Gwybodaeth am lotiau

Mae’r contract hwn wedi’i rannu’n lotiau: Na

II.2) Disgrifiad

II.2.2) Cod(au) CPV ychwanegol

31711140

33100000

33124131

33124200

33127000

33140000

33141700

33160000

33168000

33182000

33183100

33183200

33184100

33185000

33190000

33694000

33696500

33698000

33731110

38000000

42122410

II.2.3) Man cyflawni

Cod NUTS:

UK


Prif safle neu fan cyflawni:

Various Locations in the UK

II.2.4) Disgrifiad o’r caffaeliad

There are criteria detailed within the tenders documentation around Compliance/Validation stage that is required to participate within this Innovation MedTech DPs that are a Pass/Fail Requirements.

- URN Reference number provided by NHS Innovation service portal, HIN health innovation network or NHS SC Innovation Team where applicable for the following:

- Innovation Service OR

- National policy from NHSE or DHSC OR

- NICE Guidance

AND

- MHRA Product Registration

The following certification will be a requirement of the upcoming tender exercise and Applicants will be required to include evidence of this within their tender submission.

- ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the Applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage, distribution and customer service. Further information in respect of certification requirements will be set out in the notice for the forthcoming procurement. If such certificates are not in the name of the Applicant then the Applicant must supply a copy of agreements setting out the authority and responsibilities of all parties in the supply chain and provide evidence of ISO9001:2015 or equivalent for all relevant parties in the supply chain.

- Employers Liability Insurance cover of £5m per claim in the name of the Applicant

- Public Liability Insurance cover of £5m per claim in the name of the Applicant

- Product Liability Insurance cover in the name of the Applicant of £5m per claim or £5m in the annual aggregate

- Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device

Regulations 2002 or Declaration of Conformity and CE Certification to d-Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device Regulations 2002 or Declaration of Conformity and CE Certification to demonstrate compliance to Medical Devices Directive 93/42/EEC or Medical Device Regulation 2017/745 (where applicable).

The NHS has adopted PPN 06/20 (taking account of Social Value), and therefore this future DPS Agreement will include some qualitative evaluation questions on Social Value with a pass/Fail requirement. For more information please see: https://www.gov.uk/government/publications/procurement-policy-note-0620-taking-account-of-social-value-in-the-award-of-central-government-contracts. In addition, from April 2023: the NHS adopted the Government’s ‘Taking Account of Carbon Reduction Plans‘(PPN 06/21) requiring all suppliers with new contracts for goods, services, and/or works with an anticipated contract value above £5 million per annum, to publish a carbon reduction plan for their direct emissions. From April 2024, the NHS will expand this requirement for all new contracts, irrespective of value. Suppliers bidding on NHS Supply Chain tenders will also be required to submit an Evergreen Assessment, please see https://www.england.nhs.uk/nhs-commercial/central-commercial-function-ccf/evergreen/. PPN02/23 "Tackling Modern Slavery in Government Supply Chains" will also apply.

II.2.5) Meini prawf dyfarnu

Nid pris yw’r unig faen prawf dyfarnu a dim ond yn y dogfennau caffael y mae’r holl feini prawf wedi’u nodi

II.2.6) Gwerth amcangyfrifedig

Gwerth heb gynnwys TAW: 500 000 000.00 GBP

II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig

Dechrau: 03/01/2024

Diwedd: 02/01/2031

Gall y contract hwn gael ei adnewyddu: Na

II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd

II.2.10) Gwybodaeth am amrywiadau

Derbynnir amrywiadau: Ydy

II.2.11) Gwybodaeth am opsiynau

Opsiynau: Ydy

Disgrifiad o’r opsiynau:

The DPS Agreement will have an initial term of 12 months, Following the initial term of 12 months NHS Supply chain has the option to extend for a further 6 years, subject to the needs of business (and its customers) or until the published value has been exceeded of approximate spend of £500,000,000. You should note that any values which are listed in this Invitation to Participate are indicative only.

II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd

Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd: Na

Section III: Gwybodaeth gyfreithiol, economaidd, ariannol a thechnegol

III.1) Amodau ar gyfer cymryd rhan

III.1.1) Addasrwydd i ymgymryd â’r gweithgaredd proffesiynol, gan gynnwys gofynion mewn perthynas â chofrestru ar gofrestri proffesiynol neu gofrestri masnach

Rhestr a disgrifiad byr o’r amodau:

The DPS Agreement will be between NHS Supply Chain and the Supplier.

Under the DPS Agreement call off Contracts there will be two different methods of supply - one for Non-Direct Contract Products and one for Direct Contract Products.

NHS Supply Chain will be entitled to purchase the supplies and/or services identified [below] [in the tender documents as Non-Direct Contract Products which it will then make available for purchase by 1) any NHS Trust; 2) any other NHS entity; 3) any government department, agency or other statutory body and/or 4) any private sector entity active in the UK healthcare sector.

For the supplies and/or services identified as Direct Contract Products in the tender documents 1) NHS Supply Chain; 2) any NHS Trust; 3) any other NHS entity; 4) any government department, agency or other statutory body and/or 5) any private sector entity active in the UK healthcare sector will be able to enter into a direct contract with the Supplier for any of the supplies and/or services under the Framework.

Electronic ordering will be used and electronic invoicing will be accepted and electronic payment will be used. For the avoidance of doubt, and notwithstanding the estimate indicated at II.2.1, NHS Supply Chain does not guarantee any level of purchase through the framework and advises Applicants that the framework shall be established on a non-exclusive basis. Tenders and all supporting documentation for the contract must be priced in sterling and written in English. Any agreement entered into will be considered a contract made in England according to English law and will be subject to the exclusive jurisdiction of the English Courts. NHS Supply Chain is not liable for any costs (including any third party costs fees or expenses incurred by those expressing an interest, participating or tendering for this contract opportunity. NHS Supply Chain reserves the right to terminate the procurement process (or part of it), to change the basis of and the procedures for the procurement process at any time, or to procure the subject matter of the contract by alternative means if it appears that it can be more advantageously procured by alternative means. The most economically advantageous or any tender will not automatically be accepted. All communications must be made through NHS Supply Chain's eTendering portal at https://nhssupplychain.app.jaggaer.com// using the Message Centre facility linked to this particular contract notice.

III.1.2) Statws economaidd ac ariannol

Meini prawf dethol fel y’u nodir yn y dogfennau caffael


III.1.3) Gallu technegol a phroffesiynol

Lefel(au) gofynnol y safonau sydd eu hangen:

The Contracting Authority reserves the right to require groupings of entities to take a particular form, or to require one party to undertake primary legal liability or to require that each party undertakes joint and several liability.

III.2) Amodau sy’n gysylltiedig â’r contract

III.2.2) Amodau perfformiad contractau

The DPS Agreement includes obligations with respect to environmental issues and a requirement for successful suppliers to comply with the NHS Supply Chain Code of Conduct.

Section IV: Gweithdrefn

IV.1) Disgrifiad

IV.1.1) Y math o weithdrefn

Gweithdrefn gyfyngedig

IV.1.3) Gwybodaeth am gytundeb fframwaith neu system brynu ddynamig

Mae’r caffaeliad yn golygu y caiff system brynu ddynamig ei sefydlu

IV.1.8) Gwybodaeth am Gytundeb Caffael y Llywodraeth (GPA)

The procurement is covered by the Government Procurement Agreement: Ydy

IV.2) Gwybodaeth weinyddol

IV.2.2) Terfyn amser i dendrau neu geisiadau i gymryd rhan ddod i law

Dyddiad: 02/01/2031

IV.2.4) Ym mha iaith/ieithoedd y gellir cyflwyno tendrau neu geisiadau i gymryd rhan

EU

Section VI: Gwybodaeth ategol

VI.1) Gwybodaeth am ailddigwydd

Caffaeliad cylchol yw hwn: Na

VI.2) Gwybodaeth am lifau gwaith electronig

Defnyddir archebion electronig

Derbynnir anfonebau electronig

Defnyddir taliadau electronig

VI.4) Gweithdrefnau adolygu

VI.4.1) Corff adolygu

Not Applicable

Not Applicable

UK

VI.5) Dyddiad anfon yr hysbysiad hwn

03/01/2024

Codio

Categorïau nwyddau

ID Teitl Prif gategori
33696500 Adweithyddion labordy Ymweithredyddion a chyfryngau cyferbyniad
38000000 Cyfarpar labordy, optegol a thrachywir (heblaw sbectolau) Technoleg ac Offer
33100000 Cyfarpar meddygol Cyfarpar meddygol, deunydd fferyllol a chynhyrchion gofal personol
33141700 Cyflenwadau orthopedig Defnyddiau traul anghemegol meddygol a defnyddiau traul haematolegol untro
33694000 Cyfryngau diagnostig Cynhyrchion meddyginiaethol amrywiol
33698000 Cynhyrchion clinigol Cynhyrchion meddyginiaethol amrywiol
33140000 Defnyddiau traul meddygol Cyfarpar meddygol
33190000 Dyfeisiau a chynhyrchion meddygol amrywiol Cyfarpar meddygol
33182000 Dyfeisiau cynnal y galon Cymorth swyddogaethol
33168000 Dyfeisiau endosgopi, endolawfeddygaeth Technegau gweithredu
33127000 Dyfeisiau imiwno-ddadansoddi Systemau cofnodi a dyfeisiau archwilio
33124200 Dyfeisiau radiodiagnostig Dyfeisiau a chyflenwadau diagnosteg a radiodiagnosteg
31711140 Electrodau Cyflenwadau electronig
33731110 Lensys mewnllygadol Lensys cyffwrdd
33184100 Mewnblaniadau llawfeddygol Rhannau artiffisial o'r corff
33183100 Mewnblaniadau orthopedig Dyfeisiau cymorth orthopedig
33183200 Prosthesisau orthopedig Dyfeisiau cymorth orthopedig
42122410 Pympiau at ddefnydd meddygol Pympiau
33124131 Stribedi ymweithredydd Dyfeisiau a chyflenwadau diagnosteg a radiodiagnosteg
33160000 Technegau gweithredu Cyfarpar meddygol
33185000 Teclynnau clyw Cymorth swyddogaethol

Lleoliadau Dosbarthu

ID Disgrifiad
100 DU - I gyd

Cyfyngiadau Rhanbarthol ar y Rhybuddion

Mae’r prynwr wedi cyfyngu’r rhybuddion ar gyfer yr hysbysiad hwn i gyflenwyr yn y rhanbarthau canlynol.

ID Disgrifiad
Nid oes cyfyngiadau ar y rhybuddion ar gyfer yr hysbysiad hwn.

Ynglŷn â'r prynwr

Prif gyswllt:
Kayla.Richardson@supplychain.nhs.uk
Cyswllt gweinyddol:
N/a
Cyswllt technegol:
N/a
Cyswllt arall:
N/a

Gwybodaeth bellach

Dyddiad Manylion
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