Malta – Materiały medyczne – CT2308/2026 - FRAMEWORK CONTRACT FOR THE SUPPLY OF BREAST BIOPSY SITE HYDROGEL MARKERS

Rama 2308/2026 - RAMOWY UMOWA NA DOSTAWCZĘ BIOMARKERÓW HYDROGELU DLA MIEJSC BIOPSJI PIERŚCI

**Section I: Contracting authority**

I.1) Name and addresses

Official name: European Commission, Directorate-General for Health and Food Safety, Directorate C - Health Systems and Products

Postal address: Rue de la Loi, 200, 1049 Brussels

Country: Belgium

Contact person: EUROPEAN COMMISSION

E-mail: [email protected]

Internet address(es):

General address of the contracting authority: http://ec.europa.eu/dgs/health_and_consumers/index_en.htm

Address of the buyer profile: https://etendering.ted.europa.eu/cf/access.html

I.2) Joint procurement

I.3) Communication

The procurement documents are available for unrestricted and full direct access, free of charge, at: https://etendering.ted.europa.eu/cf/access.html

Additional information can be obtained from the abovementioned address

Tenders or requests to participate must be submitted electronically via: https://etendering.ted.europa.eu/cf/access.html

I.4) Type of the contracting authority

European institution/agency

I.5) Main activity

Health

**Section II: Object**

II.1) Scope of the procurement

II.1.1) Title:

Framework contract for the supply of breast biopsy site hydrogel markers

II.1.2) Main CPV code

33140000

II.1.3) Type of contract

Supplies

II.1.4) Short description:

The purpose of this framework contract is to establish a framework agreement for the supply of breast biopsy site hydrogel markers for use in the European Commission's Directorate-General for Health and Food Safety.

II.1.5) Estimated total value

Value excluding VAT: 1 500 000.00 EUR

II.1.6) Information about lots

This contract is divided into lots: no

**Section III: Conditions for participation**

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:

The economic operator must be registered in the Official Journal of the European Union (OJEU) as a supplier of medical devices.

III.1.2) Economic and financial standing

List and brief description of selection criteria:

The economic operator must provide evidence of its economic and financial standing by submitting:

- the annual accounts for the last three financial years, or

- a statement from a bank or other financial institution confirming the existence of sufficient funds to cover the contract performance, or

- a statement from a public authority confirming the existence of sufficient funds to cover the contract performance.

III.1.3) Technical and professional ability

List and brief description of selection criteria:

The economic operator must provide evidence of its technical and professional ability by submitting:

- a list of similar contracts performed in the last three years, including the value, duration and scope of each contract, or

- a certificate from a public authority or a professional body confirming the technical and professional ability of the economic operator.

III.2) Conditions for participation

III.2.1) Information about reserved contracts

III.2.2) Information about electronic auction

An electronic auction will be used: no

III.3) Conditions for participation

III.3.1) Information about a particular profession

III.3.2) Information about staff responsible for the performance of the contract

**Section IV: Procedure**

IV.1) Description

IV.1.1) Type of procedure

Open procedure

IV.1.2) Information about electronic auction

An electronic auction will be used: no

IV.1.3) Information about framework agreement

The procurement involves the establishment of a framework agreement

IV.1.4) Information about dynamic purchasing system

IV.1.5) Information about electronic auction

IV.1.6) Information about the participation of SMEs

IV.2) Administrative information

IV.2.1) Previous publication concerning this procedure

IV.2.2) Information about time limits

IV.2.3) Information about the award criteria

The most economically advantageous tender in terms of the criteria stated below:

1. Price. Weighting 60

2. Quality. Weighting 40

IV.3) Information about the award criteria

IV.3.1) Information about the award criteria

IV.3.2) Information about the award criteria

**Section V: Award of contract**

V.1) Award of contract

V.1.1) Information about the criteria for the award of the contract

V.1.2) Information about the criteria for the award of the contract

V.2) Information about the award of the contract

V.2.1) Information about the award of the contract

V.2.2) Information about the award of the contract

V.3) Information about the award of the contract

V.3.1) Information about the award of the contract

V.3.2) Information about the award of the contract

**Section VI: Complementary information**

VI.1) Information about the European Union funds

VI.2) Additional information

VI.3) Information about the European Union funds

VI.4) Information about the European Union funds

VI.5) Information about the European Union funds

VI.6) Information about the European Union funds

VI.7) Information about the European Union funds

VI.8) Information about the European Union funds

VI.9) Information about the European Union funds

VI.10) Information about the European Union funds

VI.11) Information about the European Union funds

VI.12) Information about the European Union funds

VI.13) Information about the European Union funds

VI.14) Information about the European Union funds

VI.15) Information about the European Union funds

VI.16) Information about the European Union funds

VI.17) Information about the European Union funds

VI.18) Information about the European Union funds

VI.19) Information about the European Union funds

VI.20) Information about the European Union funds

VI.21) Information about the European Union funds

VI.22) Information about the European Union funds

VI.23) Information about the European Union funds

VI.24) Information about the European Union funds

VI.25) Information about the European Union funds

VI.26) Information about the European Union funds

VI.27) Information about the European Union funds

VI.28) Information about the European Union funds

VI.29) Information about the European Union funds

VI.30) Information about the European Union funds

VI.31) Information