Reagents for hematology analyzers

The bidder must confirm the standard exclusion grounds in the ESPD, including criminal organisation, corruption and the other mandatory grounds listed in the tender documents. If an exclusion ground applies, the bidder may provide evidence of self-cleaning where allowed. The machine-readable notice also requires confirmation that the bidder can provide proof of payment of taxes and social security contributions.

The bidder must submit the completed ESPD and the technical bid data form, and confirm that the bid complies with the tender documents. The bidder must be the official representative and/or authorised reseller of the offered product and provide a manufacturer-issued document or copy proving sales rights and technical support. The offered products must bear the CE marking and comply with Regulation (EU) 2017/746, or be lawfully on the market under its transitional provisions; if products compliant with Directive 98/79/EC are offered, the manufacturer’s confirmation must be submitted that they will be replaced by products compliant with Regulation (EU) 2017/746 by the end of the transition period. Manufacturer technical data documents must also be submitted, including certificates, safety data sheets, user manuals, and storage and preservation conditions. If the bid is submitted as a joint bid, a power of attorney for the joint bidders must be attached. If equivalent solutions are used, equivalence must be explained and supporting evidence attached where necessary.