Delivery of microsurgical operating microscope, phototherapy lamp and bilirubinometer. Order. declares that being a data controller and taking into account the provisions of the Act of 10.5.2018 on the protection of personal data (hereinafter referred to as GDPR), it has implemented security measures

adequate to the risks identified by them and guaranteeing proper protection of personal data provided as part of the proceedings. A detailed information clause from Article 13 of the GDPR is included in the SWZ. Order. does not require a deposit. Order. does not provide for the possibility of awarding contracts referred to in Article 214(1)(8). provides for the application of the so-called reverse procedure referred to in Article 139(1) of the PPL.

A detailed description and method of execution of the order is included in Annex 2,3,4 to SWZ.1. The Ordering Party requests that the following means of proof be submitted together with the offer in electronic form to confirm that the offered supplies meet the requirements specified by the Ordering Party:

1) Information materials containing a description of the offered subject of the contract (prospectus, catalog, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Annex 3 to the SWZ –

excluding the terms of "Warranty and Service" (with the indication of the required parameters, the position of the offered subject of the contract).

2) Current documents and statements confirming marketing authorization and for use as a medical device that meets the requirements within the meaning of the Act of 07 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), i.e.

(a) the declaration/certificate of conformity (issued by the manufacturer or by an authorised/authorised representative) confirming that the product complies with the essential requirements;

b) the Contractor's statement confirming that the offered assortment is approved for marketing and use as a medical device in the Polish;

(c) a document certifying that the conformity assessment procedure has been carried out

with a notified body (notified body certificate), if applicable

or:

Contractor's statement confirming that the offered products meet the requirements specified by the Ordering Party and are admitted to trading

and use in Polish in accordance with applicable regulations in the event that the subject of the contract described in the SWZ has not been classified as a medical device.

2.If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for their submission or supplement within the time limit set.

The subject of the contract is executed as part of a targeted subsidy granted for co-financing from the state budget for the implementation of the investment program entitled "Establishment of an interdisciplinary treatment and diagnostics center of the Institute of Mother and Child" - contract no. DOI/FM/SIS/2/106/1155/2023.

A detailed description and method of execution of the order is included in Annex 2,3,4 to SWZ.1. The Ordering Party requests that the following means of proof be submitted together with the offer in electronic form to confirm that the offered supplies meet the requirements specified by the Ordering Party:

1) Information materials containing a description of the offered subject of the contract (prospectus, catalog, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Annex 3 to the SWZ –

excluding the terms of "Warranty and Service" (with the indication of the required parameters, the position of the offered subject of the contract).

2) Current documents and statements confirming marketing authorization and for use as a medical device that meets the requirements within the meaning of the Act of 07 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), i.e.

(a) the declaration/certificate of conformity (issued by the manufacturer or by an authorised/authorised representative) confirming that the product complies with the essential requirements;

b) the Contractor's statement confirming that the offered assortment is approved for marketing and use as a medical device in the Polish;

(c) a document certifying that the conformity assessment procedure has been carried out

with a notified body (notified body certificate), if applicable

or:

Contractor's statement confirming that the offered products meet the requirements specified by the Ordering Party and are admitted to trading

and use in Polish in accordance with applicable regulations in the event that the subject of the contract described in the SWZ has not been classified as a medical device.

2.If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for their submission or supplement within the time limit set.

The subject of the contract is executed as part of a targeted subsidy granted for co-financing from the state budget for the implementation of the investment program entitled "Establishment of an interdisciplinary treatment and diagnostics center of the Institute of Mother and Child" - contract no. DOI/FM/SIS/2/106/1155/2023.

A detailed description and method of execution of the order is included in Annex 2,3,4 to SWZ.1. The Ordering Party requests that the following means of proof be submitted together with the offer in electronic form to confirm that the offered supplies meet the requirements specified by the Ordering Party:

1) Information materials containing a description of the offered subject of the contract (prospectus, catalog, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Annex 3 to the SWZ –

excluding the terms of "Warranty and Service" (with the indication of the required parameters, the position of the offered subject of the contract).

2) Current documents and statements confirming marketing authorization and for use as a medical device that meets the requirements within the meaning of the Act of 07 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), i.e.

(a) the declaration/certificate of conformity (issued by the manufacturer or by an authorised/authorised representative) confirming that the product complies with the essential requirements;

b) the Contractor's statement confirming that the offered assortment is approved for marketing and use as a medical device in the Polish;

(c) a document certifying that the conformity assessment procedure has been carried out

with a notified body (notified body certificate), if applicable

or:

Contractor's statement confirming that the offered products meet the requirements specified by the Ordering Party and are admitted to trading

and use in Polish in accordance with applicable regulations in the event that the subject of the contract described in the SWZ has not been classified as a medical device.

2.If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for their submission or supplement within the time limit set.

The subject of the contract is executed as part of a targeted subsidy granted for co-financing from the state budget for the implementation of the investment program entitled "Establishment of an interdisciplinary treatment and diagnostics center of the Institute of Mother and Child" - contract no. DOI/FM/SIS/2/106/1155/2023.