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Individuaalselt valmistatud alalõualiigese proteesid

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Utgånget
29 september 2025
Avtalsdetaljer
Kategori
Leveranser
Referens
299560
Värde
€700,000
Plats
Estonia, Estland
Publicerad
29 augusti 2025
CPV-kod
Tidsplan för projektet

Upphandling publicerad

29 augusti 2025

Sista dag för frågor

22 september 2025

Sista anbudsdag

29 september 2025

Anbudsöppning

29 september 2025

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Budget
€700,000
Varaktighet
Ej angivet
Plats
Estonia
Typ
Leveranser
Marknadsjämförelse
Genomsnittligt vinnande pris
€92,792
Genomsnittligt antal anbud
2.2
Konkurrens
Låg
Vinnande små och medelstora företag
86%
3,220 analyserade upphandlingar

Ursprunglig beskrivning av upphandling

Käesoleva hanke eesmärk on sõlmida raamleping individuaalselt valmistatud alalõualiigese proteeside (edaspidi toode) ostmiseks. Leping sõlmitakse kolmeks (3) aastaks või maksimaalse koguse täitumiseni, sõltuvalt sellest, kumb tingimus saabub varem. Hankija soovib vastavalt tervishoiuteenuse osutamisel tekkivale vajadusele osta nii unilateraalseid endoproteese (ühepoolne, üks endoprotees) kui ka bilateraalseid endoporteese (kahepoolne, kaks endoproteesi).
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Krav och kvalifikationer

22 krav inom 5 kategorier

Inlämning (5)
Obligatorisk (5)
Regelefterlevnad (4)
Teknisk (5)
Ekonomisk (3)
SUBMISSION REQUIREMENTS5
--Complete and sign Form III “Application to Participate” (mandatory cover sheet)
--Upload completed ESPD (extended version) with all qualification evidence attached
--Insert fully completed technical-compliance table (Annex 1) responding point-by-point to Lisa 1 & Lisa 2 specifications
MANDATORY QUALIFICATIONS5
--Hold a valid medical-device manufacturing or EU-import licence (Class III custom maxillo-facial implants)
--Possess ISO 13485 certification covering design & manufacture of custom mandibular joint prostheses
--Demonstrate ≥1-year proven track record of supplying similar individually-made TMJ endoprostheses to hospitals (reference letters required)
COMPLIANCE REQUIREMENTS4
--Certify that no Russian-linked subcontractors or suppliers account for ≥10 % of contract value (Reg. 2022/576)
--Sign and return the hospital’s GDPR “Authorised Processor” agreement before contract commencement
--Pledge compliance with EU/EE environmental & sustainable-practice obligations stated in framework contract
TECHNICAL REQUIREMENTS5
--Manufacture each prosthesis individually from Ti6Al4V+TiN and UHMWPE/titanium per provided material specs
--Provide full CAD/CAM design file, patient-specific surgical guides, anatomical 3-D models, trial implants and sterilisation validation
--Supply full documentation in Estonian AND English (IFU, implant passport, traceability records)
FINANCIAL REQUIREMENTS3
--Bid the lowest all-inclusive unit price (Euro) for both unilateral and bilateral prostheses; award is 100 % price-based
--Demonstrate adequate financial capacity (no bankruptcy, no negative equity) – evidence to be uploaded in ESPD
--No mandatory turnover threshold stated, but prices must remain fixed for the entire 3-year framework

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Dokument

11 dokument tillgängliga med AI-sammanfattningar

VastavustingimusedPDF
299560_vastavustingimused.pdf -- 19.9 KB

This compliance-only document mandates (under EU Council Reg. 2022/576) that no Russian-linked subcontractors/suppliers representing >10 % of contract value may be used and, if bidding as a consortium, a joint-authorisation letter must be uploaded—so any Estonian or EU custom mandibular-joint prosthesis maker that can certify non-Russian supply chains and, if applicable, provide the consortium power-of-attorney should proceed; all other technical/qualification criteria will appear in later tender files.

Pakkuja esitab tehnilistele tingimustele vastava pakkumuse Lisa 1 Word- formaadi...DOC
Lisa_1_tehnilised tingimused osale 1.docx -- 27.5 KB

Tartu University Hospital seeks a 3-year framework supplier for fully custom-made TMJ endoprostheses (unilateral & bilateral) that must be individually CAD/CAM-designed from Ti6Al4V+TiN and UHMWPE/titanium, delivered with patient-specific surgical guides, anatomical models, trial implants and Estonian/English documentation—only bidders that can prove ISO 13485 quality and provide the mandatory technical compliance table in Annex 1 should consider bidding.

Pakkuja esitab tehnilistele tingimustele vastava pakkumuse Lisa 2 Word- formaadi...DOC
Lisa 2_tehnilised tingimused osale 2.docx -- 27.0 KB

Tartu University Hospital seeks a 3-year framework supplier for fully custom-made mandibular joint endoprostheses (unilateral & bilateral) that must be individually CAD/CAM-designed from Ti6Al4V+TiN and UHMWPE/titanium, delivered with patient-specific surgical guides, anatomical models and Estonian/English documentation—compliance with every listed material and component specification is mandatory, so only manufacturers or authorised dealers already CE-marked for Class III custom maxillo-facial implants should bid.

Esitada hankemenetluses osalemise avaldus vastavalt Lisa 5 vormile III.DOC
Lisa_5_vorm_III.docx -- 31.8 KB

This document is merely the blank “Form III – Application to Participate” that every bidder must complete and submit (mandatory) to be admitted to the Tartu University Hospital’s 3-year framework tender for individually-manufactured mandibular joint prostheses; no technical, financial or qualification criteria are stated here, so firms should look elsewhere in the full tender dossier to decide whether they can meet the actual requirements.

Hindamiskriteeriumid ja hinnatavad näitajadPDF
299560_hindamiskriteeriumid.pdf -- 4.8 KB

Tartu University Hospital seeks the lowest-price supplier for a 3-year framework contract to deliver individually manufactured mandibular joint prostheses (both unilateral and bilateral units), with award based 100% on submitted unit prices—no additional technical or quality criteria—so only manufacturers/distributors able to supply CE-marked custom implants at minimal margins should bid.

Hankepass täiendatavate selgitustegaPDF
299560_hankepass_taiendavate_selgitustega.pdf -- 64.0 KB

Tartu Ülikooli Kliinikum otsib 3-aastaseks raamlepinguks tarnijat, kes suudab individuaalselt valmistada kuni 80 alalõualiigese endoproteesi aastas (nii unilateraal- kui bilateraalsed), mistõttu on kohustuslik omada meditsiiniseadmete tootmise/maaletoomise luba, ISO 13485 kvaliteedijuhtimissüsteemi ning tõendatavat kogemust sarnaste kliiniliste implantaatide tarnimisest haiglale.

AndmetöötluslepingDOC
Andmetöötlusleping_volitatud töötleja.docx -- 36.2 KB

This document is only the GDPR data-processing agreement template that Tartu University Hospital will require the winning supplier to sign; it contains no tender requirements, product specifications, qualifications or evaluation criteria for the mandibular-joint prosthesis supply itself.

Juhised pakkujalePDF
Juhised pakkujale.pdf -- 169.6 KB

Tartu University Hospital seeks a 3-year framework supplier (EU/WTO firms eligible) for individually manufactured mandibular joint prostheses—both unilateral and bilateral—requiring full compliance with all stated technical/specification documents (mandatory) and ability to sign the framework contract within 3 working days of award.

RaamlepingPDF
Lisa_3_raamleping.pdf -- 194.2 KB

Tartu University Hospital seeks a 3-year framework supplier for up to 40 individually-made mandibular joint prostheses (unilateral & bilateral), mandatory compliance with EU/EE quality standards and sustainable-practice pledge, requiring proven CE-marked device registration, qualified personnel and ability to deliver on-call without minimum purchase guarantee.

Ühispakkujate volikiriDOC
Lisa_5_vorm_I.docx -- 31.8 KB

This document is merely a blank template (Form I – Joint Tenderers’ Authorisation) that two or more firms must complete and sign if they intend to submit a joint bid for the Tartu University Hospital’s 3-year framework contract for individually manufactured lower-jaw joint prostheses; it contains no technical requirements, qualification criteria or evaluation rules.

Volikiri pakkumuse allkirjastamiseksDOC
Lisa_5_vorm_II.docx -- 31.1 KB

This document is merely a blank “Power of Attorney” template (Form II) that a bidder must complete and enclose with its offer, so it contains no technical requirements, qualification criteria or evaluation rules—only the mandatory need to submit a properly signed power of attorney authorising the person who signs the bid.

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