ETENDERS

Contract notice

Information

Published

Date of dispatch of this notice: 13/12/2019

Expire date: 20/01/2020

External Reference: 2019-284974

TED Reference: 2019/S 243-596608

Contract notice

Contract notice

Directive 2014/24/EU

Section I: Contracting authority

I.1)

Name and addresses

Trinity College Dublin, the University of Dublin
2200007u
College Green
Dublin 2
Co. Dublin
IE
Contact person: Kevin Ryan
Telephone: +353 18962376
E-mail: ryank8@tcd.ie
Internet address(es):
Main address: http://www.tcd.ie
Address of the buyer profile: https://irl.eu-supply.com/ctm/Company/CompanyInformation/Index/336

I.3)

Communication

Access to the procurement documents is restricted. Further information can be obtained at:  
http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=159813&B=ETENDERS_SIMPLE
Additional information can be obtained from
the abovementioned address:  
Tenders or requests to participate must be submitted
electronically via:  http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=159813&B=ETENDERS_SIMPLE
Tenders or requests to participate must be submitted
to the abovementioned address
I.4)

Type of the contracting authority

Body governed by public law
I.5)

Main activity

Education

Section II: Object

II.1)

Scope of the procurement

II.1.1)

Title

Medical Device Manufacture for a Research consortium led by Trinity College Dublin
Reference number:  TCD-19-127 Medical Device
II.1.2)

Main CPV code

33190000  -  Miscellaneous medical devices and products
II.1.3)

Type of contract

Supplies
II.1.4)

Short description

Researchers within Trinity College Dublin have developed the Selio Sealant System™, a sterile, single-use medical device to prevent complications associated with percutaneous access of the body. The device is designed for use as part of a CT-guided interventional procedure with the end-user being an Interventional Radiologist.
Trinity College Dublin is seeking a suitable Contract Manufacturing Organisation (CMO) that can facilitate the development, manufacture, assembly, packaging & sterilization of these sub-components of the Selio Sealant System™. The CMO will develop the product under their Quality Management System. All design & quality files generated as part of this development process must be suitable to be included in the Design History File for the product.
II.1.5)

Estimated total value

Value excluding VAT: 350000.00  EUR
II.1.6)

Information about lots

This contract is divided into lots: no
II.2)

Description

II.2.2)

Additional CPV code(s)

33190000  -  Miscellaneous medical devices and products
II.2.4)

Description of the procurement

Researchers within Trinity College Dublin have developed the Selio Sealant System™, a sterile, single-use medical device to prevent complications associated with percutaneous access of the body. The device is designed for use as part of a CT-guided interventional procedure with the end-user being an Interventional Radiologist.
Trinity College Dublin is seeking a suitable Contract Manufacturing Organisation (CMO) that can facilitate the development, manufacture, assembly, packaging & sterilization of these sub-components of the Selio Sealant System™. The CMO will develop the product under their Quality Management System. All design & quality files generated as part of this development process must be suitable to be included in the Design History File for the product.
II.2.5)

Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents
II.2.6)

Estimated value

Value excluding VAT: 350000.00  EUR
II.2.7)

Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48
This contract is subject to renewal: no
II.2.9)

Information about the limits on the number of candidates to be invited

Envisaged minimum number: 1  /  Maximum number: 3
Objective criteria for choosing the limited number of candidates:
It is possible only one bidder will respond to this competition due to the specialised requirement.
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: yes
Identification of the project: EIT KIC 2020 innovation grant Selio (20186)

Section III: Legal, economic, financial and technical information

III.1)

Conditions for participation

III.1.2)

Economic and financial standing

Selection criteria as stated in the procurement documents
III.1.3)

Technical and professional ability

Selection criteria as stated in the procurement documents
III.2)

Conditions related to the contract

III.2.3)

Information about staff responsible for the performance of the contract

Obligation to indicate the names and professional qualifications of the staff assigned to performing the contract

Section IV: Procedure

IV.1)

Description

IV.1.1)

Type of procedure

Restricted procedure
IV.1.3)

Information about a framework agreement or a dynamic purchasing system

The procurement involves the establishment of a framework agreement
Framework agreement with a single operator
IV.1.8)

Information about the 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:  20/01/2020
Local time:  12:00
IV.2.3)

Estimated date of dispatch of invitations to tender or to participate to selected candidates

Date: 24/02/2020
IV.2.4)

Languages in which tenders or requests to participate may be submitted

English
IV.2.6)

Minimum time frame during which the tenderer must maintain the tender

Duration in months : 48  (from the date stated for receipt of tender)

Section VI: Complementary information

VI.1)

Information about recurrence

This is a recurrent procurement:  no
VI.2)

Information about electronic workflows

Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
VI.4)

Procedures for review

VI.4.1)

Review body

High Court
Dublin
IE