Bulgaria – Medical consumables – “Supply of gloves – non-sterile nitrile – S, M, L, XL for the needs of the Emergency Medical Care Center – Sofia within the framework of the DPS”

Opportunity description

The subject of the public procurement is the supply of gloves – non-sterile nitrile – S, M, L, XL for the needs of the Emergency Medical Care Center – Sofia within the framework of the DPS. The estimated quantity is 400000 units in view of the contracting authority's planned needs, taking into account the actual activities of the medical staff at EMCC–Sofia and the equipping of medical bags. The contracting authority is not bound by the indicated quantities and will place orders according to its specific needs during the contract. Performance requirements: 1. The contract will be valid from the date of its signing until 19.03.2027. 2. The contractor is obliged to make each delivery to the contracting authority's address within 24 /twenty-four/ hours after receiving an order (specifying items and quantities) from the contracting authority. The risk of accidental loss of or damage to the goods passes to the contracting authority after acceptance of the delivery at the place of delivery. 3. The place of performance is at the contracting authority's location – Sofia, 129 “Vasil Levski” Blvd. 4. Upon handover of the delivery, all items must be packaged in a manner that guarantees their storage and transport, as well as any additional requirements imposed by the contracting authority (e.g. the original cartons must be preserved, they must be in liquid-impermeable bags, etc.). The packaging of the goods must protect them from all damage due to weather conditions and transport, must be intact, and must not be wet. 5. The delivered goods must have a remaining shelf life of at least 50% of the total shelf life (items with a shorter shelf life are permissible only where it is objectively impossible to comply with this requirement and/or with the contracting authority's express written consent). Each item must be accompanied by the relevant documentation for its use. 6. Payment shall be made within 30 /thirty/ days of the delivery. The price includes all costs for delivery to the contracting authority's address (including all customs duties, taxes, fees, transport, VAT, etc.). The price of medical devices for which there is a statutorily regulated maximum value must not exceed that maximum value (e.g. the value under Art. 30b of the Medical Devices Act). The contractor is obliged to monitor the price referred to in the preceding sentence and invoice accordingly. 7. Contractors must supply goods that meet the statutorily established quality requirements and European standards applicable to them (including those mandatory for medical devices: they must comply with the requirements of the Medical Devices Act, including bearing the CE marking, bearing the identification number of the notified body where the relevant conformity assessment procedure requires it, legible marking of the date of manufacture, shelf life, batch number, and all other data specified in Art. 16 of the Medical Devices Act must be displayed on the device, its packaging, and in the instructions for use, instructions for use and others). All goods must be fit for their intended use. 8. Donations or the provision of equipment in another manner as a condition for concluding a contract are not accepted. Anyone wishing to make a donation to EMCC-Sofia may do so in accordance with the relevant procedure provided for this purpose, but not as part of the public procurement. 9. Pursuant to Art. 37, para. 1, item 3 of Ordinance No. 7 of 31.03.2021 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value up to which they are paid for, for the relevant medical device there must be no data registered with the Bulgarian Drug Agency and/or EUDAMED concerning incidents during the last 18 months, nor batches blocked or withdrawn from the market for reasons related to the safety of medical devices during the last 18 months, according to information provided by the Bulgarian Drug Agency. 10. In accordance with Art. 37, para. 1, item 2 of Ordinance No. 7 of 31.03.2021 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value up to which they are paid for, the medical devices are required to be included in the list under Art. 1, item 1, letter “b” of the above-mentioned ordinance, and the proposed price must be lower than that indicated in the list. 11. In accordance with Art. 37, para. 1, item 4 of Ordinance No. 7 of 31.03.2021 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value up to which they are paid for, the medical devices must be paid for in at least three Member States of the European Union through their respective publicly funded payment systems or respective health insurance funds. 12. If the participant submits an offer for an item that is part of a medical device (e.g. replacement glass) and that is not independently included in the list under the above-mentioned ordinance, the participant shall provide information on the registration of the complete medical device. Procedure: restricted. Estimated value: 16,000 EUR. Review the original TED notice for the complete requirement, lots, amendments and attachments.