Negotiated procedure without prior call for competition - Voluntary ex ante Transparency Notice for the Provision of a Confocal Laser Scanning Microscope system for Dermatology, including Training and maintenance services for 10 years

The proposed contract is for the purchase of the VivaScope Combination unit; which is an integrated Dermascopic and Confocal Imaging system consisting of a high-quality video dermatoscope, an arm-mounted confocal microscope (the VS1500 Gen4) for larger area, dermoscopy-correlated images of lesions, plus a handheld VS3000 confocal handpiece for quick evaluation …

CPV: 33100000 Equipamiento médico, 33166000 Aparatos de dermatología, 33124100 Aparatos para diagnóstico, 38510000 Microscopios, 50421000 Servicios de reparación y mantenimiento de equipos médicos, 50410000 Servicios de reparación y mantenimiento de aparatos de medida, pruebas y verificación
Lugar de ejecución:
Negotiated procedure without prior call for competition - Voluntary ex ante Transparency Notice for the Provision of a Confocal Laser Scanning Microscope system for Dermatology, including Training and maintenance services for 10 years
Organismo adjudicador:
St. Vincent's University Hospital
Número de premio:
SVUH-24002

1. Buyer

1.1 Buyer

Official name : St. Vincent's University Hospital
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Negotiated procedure without prior call for competition - Voluntary ex ante Transparency Notice for the Provision of a Confocal Laser Scanning Microscope system for Dermatology, including Training and maintenance services for 10 years
Description : The proposed contract is for the purchase of the VivaScope Combination unit; which is an integrated Dermascopic and Confocal Imaging system consisting of a high-quality video dermatoscope, an arm-mounted confocal microscope (the VS1500 Gen4) for larger area, dermoscopy-correlated images of lesions, plus a handheld VS3000 confocal handpiece for quick evaluation and mapping of lesions and for access to more anatomically difficult areas. The combo unit is on a cart and integrates VivaScope® and DermaGraphix® imaging systems to present one coherent software interface to generate and manage high-definition clinical images, whole body photography (via integration with the DermaGraphix body mapping solution), dermatoscopic, and confocal images. The system is to be integrated with VivaLAN software running on a local server, so that all patient information and image data is stored centrally and all acquired images can be viewed on computers connected to the network, leading to an efficient workflow enabling a high throughput of patients. The system comprises the capital equipment and includes a two-year warranty; annual maintenance, specialized technician support, and the option to have all parts included with the package. The system has a service and maintenance life of seven (7) years. Consumables are comprised of tissue windows, which are stuck to the skin to allow the dermoscopy and confocal images to be correlated, and ultrasound gel and mineral oil which are used to couple the infrared light into the skin. VivaScope are to provide an extensive modular training program and ongoing support; VivaTeach, a telemedicine learning tool enabling knowledge transfer from established confocal imaging experts to new VivaScope users.
Procedure identifier : cea81aaf-f3c8-4a87-868f-4f1c47620631
Previous notice : 210840-2024
Internal identifier : SVUH-24002
Type of procedure : Negotiated without prior call for competition
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33100000 Medical equipments
Additional classification ( cpv ): 33166000 Dermatological devices
Additional classification ( cpv ): 33124100 Diagnostic devices
Additional classification ( cpv ): 38510000 Microscopes
Additional classification ( cpv ): 50421000 Repair and maintenance services of medical equipment

2.1.2 Place of performance

Country : Ireland
Anywhere in the given country

2.1.3 Value

Estimated value excluding VAT : 500 000 Euro
Maximum value of the framework agreement : 500 000 Euro

2.1.4 General information

Additional information : The Contracting Authority observed a stand still period of 30 calendar days before entering into a contract, starting a day after the date of publication of Voluntary ex Ante Transparency Notice notice 210840-2024 OJ S 71/2024 published on 10/04/2024.
Legal basis :
Directive 2014/24/EU
Directive 2014/24/EU Article 32.2.b.ii - Negotiated without prior call for competition.

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Negotiated procedure without prior call for competition - Voluntary ex ante Transparency Notice for the Provision of a Confocal Laser Scanning Microscope system for Dermatology, including Training and maintenance services for 10 years
Description : The proposed contract is for the purchase of the VivaScope Combination unit; which is an integrated Dermascopic and Confocal Imaging system consisting of a high-quality video dermatoscope, an arm-mounted confocal microscope (the VS1500 Gen4) for larger area, dermoscopy-correlated images of lesions, plus a handheld VS3000 confocal handpiece for quick evaluation and mapping of lesions and for access to more anatomically difficult areas. The combo unit is on a cart and integrates VivaScope® and DermaGraphix® imaging systems to present one coherent software interface to generate and manage high-definition clinical images, whole body photography (via integration with the DermaGraphix body mapping solution), dermatoscopic, and confocal images. The system is to be integrated with VivaLAN software running on a local server, so that all patient information and image data is stored centrally and all acquired images can be viewed on computers connected to the network, leading to an efficient workflow enabling a high throughput of patients. The system comprises the capital equipment and includes a two-year warranty; annual maintenance, specialized technician support, and the option to have all parts included with the package. The system has a service and maintenance life of seven (7) years. Consumables are comprised of tissue windows, which are stuck to the skin to allow the dermoscopy and confocal images to be correlated, and ultrasound gel and mineral oil which are used to couple the infrared light into the skin. VivaScope are to provide an extensive modular training program and ongoing support; VivaTeach, a telemedicine learning tool enabling knowledge transfer from established confocal imaging experts to new VivaScope users.
Internal identifier : 1

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33100000 Medical equipments
Additional classification ( cpv ): 33166000 Dermatological devices
Additional classification ( cpv ): 33124100 Diagnostic devices
Additional classification ( cpv ): 38510000 Microscopes
Additional classification ( cpv ): 50410000 Repair and maintenance services of measuring, testing and checking apparatus
Quantity : 1 piece
Options :
Description of the options : The system has a service and maintenance life of seven (7) years (the Initial Term); SVUH may (but shall be under no obligation to) extend the term of the Maintenance Agreement for a 12 month period from the end of the Initial Term on or before the last day of the Initial Term, and on an annual basis for 120 months, being the anticipated duration of the useful life of the system.

5.1.2 Place of performance

Country : Ireland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Start date : 01/01/2025
Duration : 10 Year

5.1.4 Renewal

Maximum renewals : 3

5.1.5 Value

Estimated value excluding VAT : 500 000 Euro

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no

5.1.7 Strategic procurement

Aim of strategic procurement : No strategic procurement

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Direct Award
Description of the method to be used if weighting cannot be expressed by criteria : Direct award. The contract can be provided only by a particular economic operator because of an absence of competition for technical reasons.
Justification for not indicating the weighting of the award criteria : The VivaScope in vivo Confocal Microscope provides a unique capability to diagnose and map dermatological conditions at the bedside and without prior excision of tissue. A cellular resolution of significantly better than one micron allows melanocytic lesions and melanoma to be diagnosed. Additionally, the handheld VS 3000 allows melanoma and lentigo maligna to be mapped before excision, leading to more accurate surgery and better outcomes. VIVASCOPE GmbH is currently the sole authorized provider of VivaScope®products in Europe. These items are not available from any other distributor or dealer. Competitors do not have the optical resolution to diagnose Melanoma or other melanocytic lesions.

5.1.12 Terms of procurement

Information about review deadlines : Please refer to the European Communities (Public Authorities’ Contracts) (Review Procedures) Regulations 2010 (SI 130/2010) as amended (the Public Contracts Remedies Regulations).

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : The High Court of Ireland -
Information about review deadlines : Please refer to the European Communities (Public Authorities’ Contracts) (Review Procedures) Regulations 2010 (SI 130/2010) as amended (the Public Contracts Remedies Regulations).
Organisation signing the contract : St. Vincent's University Hospital

6. Results

Maximum value of the framework agreements in this notice : 500 000 Euro
Approximate value of the framework agreements : 500 000 Euro
Direct award :
Justification for direct award : The contract can be provided only by a particular economic operator because of an absence of competition for technical reasons
Other justification : The VivaScope in vivo Confocal Microscope provides a unique capability to diagnose and map dermatological conditions at the bedside and without prior excision of tissue. A cellular resolution of significantly better than one micron allows melanocytic lesions and melanoma to be diagnosed. Additionally, the handheld VS 3000 allows melanoma and lentigo maligna to be mapped before excision, leading to more accurate surgery and better outcomes. VIVASCOPE GmbH is currently the sole authorized provider of VivaScope® products in Europe. These items are not available from any other distributor or dealer. Competitors do not have the optical resolution to diagnose Melanoma or other melanocytic lesions.
Identifier of the previous procedure that justifies direct award : 5a18698d-794d-4533-9d5e-8baf577adbc6

6.1 Result lot ldentifier : LOT-0001

At least one winner was chosen.
Framework agreement :
Maximum value of the framework agreement : 500 000 Euro
Re-estimated value of the framework agreement : 500 000 Euro

6.1.2 Information about winners

Winner :
Official name : VIVASCOPE GmbH
Tender :
Tender identifier : VIVASCOPE GmbH
Identifier of lot or group of lots : LOT-0001
Subcontracting : No
Contract information :
Identifier of the contract : CM24008
Organisation signing the contract : St. Vincent's University Hospital

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders submitted electronically
Number of tenders or requests to participate received : 1

8. Organisations

8.1 ORG-0001

Official name : St. Vincent's University Hospital
Registration number : 338585
Postal address : Elm Park
Town : Dublin
Postcode : D04 T6F4
Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Telephone : 012214000
Internet address : https://www.stvincents.ie/
Roles of this organisation :
Buyer
Organisation signing the contract

8.1 ORG-0002

Official name : The High Court of Ireland
Registration number : The High Court of Ireland
Department : The High Court of Ireland
Postal address : Four Courts, Inns Quay, Dublin 7
Town : Dublin
Postcode : D07 WDX8
Country subdivision (NUTS) : Dublin ( IE061 )
Country : Ireland
Telephone : +353 1 8886000
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : European Dynamics S.A.
Registration number : 002024901000
Department : European Dynamics S.A.
Town : Athens
Postcode : 15125
Country subdivision (NUTS) : Βόρειος Τομέας Αθηνών ( EL301 )
Country : Greece
Telephone : +30 2108094500
Roles of this organisation :
TED eSender

8.1 ORG-0004

Official name : VIVASCOPE GmbH
Registration number : HRB No. 258401; UST-ID-Nr. DE 337284294
Town : Munich
Postcode : 81829
Country subdivision (NUTS) : München, Kreisfreie Stadt ( DE212 )
Country : Germany
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0001

11. Notice information

11.1 Notice information

Notice identifier/version : 4c0c2414-a37c-4c55-ad08-1e69530b8671 - 01
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 10/03/2025 12:51 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00156368-2025
OJ S issue number : 49/2025
Publication date : 11/03/2025