Frequently asked questions

This section includes the questions received during the Open Market Consultation (OMC), as well as the questions and answers related to the Call for Tenders submitted through the Tuttogare platform.

For any other questions about THERESA PCP, please contact us at questions@theresa-pcp.eu

Call for Tenders

1. Can I associate with a THERESA’s partner hospital for the tender or try the technology? ​

No. Selected contractors will test and pilot their solution withing 2 hospitals of THERESA PCP consortium, but it is not possible to summit a joint tender with any partner of the THERESA consortium.

Each contractor will keep the ownership of their bakcgorund IPRs, as well as the IPR attached to the results they generate during the PCP implementation.

The PBG has the right to:

  1. Receive an irrevocable, royalty free, non-exclusive license for all healthcare centres, services and establishments belonging to the PBGs to use the developed technology up until TRL7 or 8 (or up to the point it was developed by contractors of Phase 1 and 2) for indefinite time. This entails the access to the PCP Results, on a royalty-free basis, for their own use, non-commercially and at no additional cost. This includes all IPRs of what has been developed in the PCP and the pre-existing rights that are needed to perform the Project for the purpose of executing the Project as well as for non-commercial research purposes.
  2. Grant (or require the contractors to grant) non-exclusive licences to third parties to exploit the results under Fair, Reasonable and Non-Discriminatory (FRAND) conditions (without the right to sub-license).
  3. Require the contractors to transfer ownership of the IPR if the contractors fail to comply with their obligations, notably concerning the protection or exploitation of the results or to protect public interests (including security interests) – this applies for Results under the three phases – or to commercialize the solution – this applies for Results under phase.

Yes. Tenders may be submitted by a single entity or in collaboration with others. The latter can involve either submitting a joint tender or subcontracting, or a combination of the two approaches.

However, each tenderer may only participate in one tender (alone, as part of a consortium, main contractor or as subcontractor). This means that the tenderer may only submit a bid on his own or in one (temporary) consortium. It also means that an economic operator or affiliated entity can participate as a subcontractor in one tender. Failure to do so leads to the exclusion of all bids in which they take part.

Microbiological analyses will be carried out by SAS in accordance with what is described in Section 20 of Annex 6. The remaining analyses required to quantify other contaminants (cytostatics, contrast agents, and antibiotics) will be performed in laboratories subcontracted by CHV. In both cases, if it is considered appropriate to involve either of the two partners to carry out the analyses, the cost will be covered by these two entities.  For the detection and quantification of microbiological contaminants, the following molecular techniques and analyses will primarily be used: Quantitative PCR (qPCR): Primary technique for the quantitative molecular detection of ARG.Whole-Genome Sequencing (WGS): Sequencing platforms such as MiSeq (Illumina) will be employed for the detailed characterization of bacterial strains used in spiking (enrichment) assays. This ensures that the resistant bacteria utilized during testing are precisely identified genetically.Automated DNA Extraction: The laboratory utilizes TECAN platforms for automated DNA extraction and genomic library preparation, which guarantees the standardization of molecular samples.Bioinformatic Analysis: Specialized software including CLC Genomics Workbench, Ridom™ SeqSphere+, and BioNumerics will be used to analyze the sequences obtained and for the molecular typing of multidrug-resistant pathogensChemical analyses for the relevant target contaminants ( cytostatics, X-ray contrast agents and antibiotics)may be performed by specialised external laboratories coordinated or subcontracted by CHV, where applicable. The scope of these analyses should cover the whole panel of target contaminants as listed in TD1 Request for Tenders, Section 3.5 Award Criteria. The specific Phase 2 Test Plan will be prepared by the contractor using the applicable template and requirements, and will be subject to review and formal approval by SAS before testing starts. The exact analytical panel, number and type of samples, sampling points, analytical methods and quality requirements will therefore be defined in the approved Phase 2 Test Plan. Accordingly, the coverage applies to the analyses required for the agreed Phase 2 testing protocol and should not be interpreted as covering any additional or non-agreed analyses outside that approved Test Plan. Operational costs related to the prototype itself, including installation, operation, optimisation, consumables, transport, waste handling and safe discharge management, remain the responsibility of the contractor, as established in the tender documents.

The Public Buyers Group, primarily through SAS, can provide hospital wastewater for Phase 2 testing, even if conducted at the contractor’s own facilities.However, the contractor must propose this matrix in their Phase 2 Test Plan and obtain formal approval from SAS prior to testing. While real wastewater is available, the tender documents emphasize that synthetic spiked wastewater is the standard method used to ensure that testing is fully representative and comparable across all prototypes. If real wastewater is used, contractors must ensure that it is representative of the intended application and includes all target contaminants relevant to the evaluation.If a contractor opts for off-site testing using samples provided by SAS, they are fully responsible for the logistics and transportation cost. This includes the shipment of influent samples to the contractor’s laboratory and the return of post-test samples to SAS for analysis, if applicable. Ultimately, the contractor retains total operational and technical responsibility for the prototype and must justify the statistical adequacy and representativeness of their selected matrix within the approved Test Plan. Please check Annex 6. Phase 2 testing strategy & requirements.

Please see section 3.3. Selection criteria of TD1 Request for Tenders, in particular selection criterion 2: «The CV must clearly demonstrate at least 5 (five) years of experience in managing multi-disciplinary innovation projects and/or multi-disciplinary integration projects with challenges on a European scale. The individual must have verifiable experience in monitoring tasks, managing planning and budgets, coordinating stakeholders, and ensuring project governance. Together with the CV it is necessary to submit at least one reference letter signed by a public or private client referred to at least 1 (one) such project, in which the expert has taken part. The role is not technical in nature: the primary focus is on a multi-disciplinary project delivery and strategic alignment across domains, rather than on content-level or technical development». The more information the CV provides, the more straightforward will be to ensure compliance with this criterion. Please note that the projects do not necessarily need to be «European public projects», they can refer to «managing multi-disciplinary innovation projects and/or multi-disciplinary integration projects with challenges on a European scale». A European Public project would be indeed a great reference, but not the only possibility. For the Environmental Sustainability Expert profiel, please see section 3.3. Selection criteria of TD1 Request for Tenders, in particular selection criterion 2:  «At least 1 (one) CV of an expert with minimum 5 (five) years of experience in sustainability experience projects/designs. The CV will specifically indicate at least 1 (one) project linked to sustainability design, assessment, or implementation in the last 5 (five) years.» As indicated, the project should be linked to sustainability design, assessment, or implementation. The provider has certain leeway to select a project that covers these aspects (not necessarily altogether).

This is indeed possible. One single professional who complies with several of the criteria can be proposed to cover these criteria on their own. In any case, please note that the personnel mentioned in criteria 2, 3, 4, 5, 6 and 7 will be required to execute the contract. Please see section 3.3. Selection criteria of TD1 Request for Tenders.

The Procurers cannot pre-assess or confirm the eligibility of specific individuals prior to the formal evaluation of tenders. As stated in section 3.3. Selection criteria of TD1 Request for Tenders, in particular selection criterion 3: «At least 1 (one) CV of an expert with experience and knowledge on cytostatics, and/or contrast agents and/or antibiotics (in water) over the past 5 (five) years. The CV will specifically indicate at least 1 (one) project/research linked to the removal of cytostatics, and/or contrast agents and/or antibiotics in water in the last 5 (five) years. They must be employed by the Contractor(s) at the time of executing the contract.Compliance with this criterion will be assessed based on the information and evidence provided in the submitted tender. Tenderers should therefore clearly demonstrate the relevance of the proposed expert’s experience to the contaminants and objectives addressed by the THERESA PCP.

The Phase 3 pilot system is not required to treat the total wastewater flow generated by a hospital. Instead, the pilot shall operate at a scale that is representative of the intended deployment model proposed by the tenderer (e.g. a specific hospital department, unit, source-separated stream, or other justified treatment scope). As specified under requirement SSI1.4 (Solution Layout), tenderers may propose and justify centralised, decentralised, or hybrid treatment configurations. Consequently, a decentralised solution targeting a specific hospital department or unit may be validated at the corresponding wastewater flow generated by that deployment scenario, rather than at the total hospital flow. The key requirement is that the pilot installation is representative of the intended final deployment configuration and operates under real hospital conditions. Tenderers shall justify the selected treatment capacity and deployment scale in relation to their proposed implementation model and demonstrate that the pilot is capable of generating statistically robust, traceable and representative performance data for the purposes of verification. The pilot shall be of sufficient scale to support the generation of performance data required under the ETV process and ISO 14034 verification framework, reflecting the operational and treatment conditions of the proposed solution. Therefore, a decentralised pilot treating may be acceptable, provided that it is representative of the intended deployment model, is technically justified, and generates sufficient data to support the required Phase 3 verification activities.

As specified in section 3.5. Award Criteria of TD1 Request for Tenders, particularly under Space & Site Integration requirements, it is not prescribed a specific reactor size, module volume or architecture. The purpose of the requirements is not to favour a particular technology, but to ensure that proposed solutions can be realistically deployed and scaled within hospital environments. Contractors are therefore free to propose the technical configuration that they consider most appropriate for their technology, provided that the proposed design demonstrates technical feasibility, scalability, and suitability for the intended deployment scenario. There is no predefined «optimal» trade-off between modularity and treatment capacity. Tenderers should justify how their proposed configuration represents the most appropriate balance for their technology and intended deployment model, while ensuring compliance with the requirements related to space efficiency, site integration, scalability and Phase 3 pilot validation.

a) The timeline set out in TD1. Request for tenders reflects the expected overall schedule for Phase 3. The detailed planning of site access, any necessary infrastructure adaptations, installation activities and commissioning will be coordinated between the selected contractors and the Procurers following the allocation of pilot sites.Contractors should note that information on the test sites is already provided in Annex 1. Test Sites and that site visits may be carried out during the different phases, as indicated under SSI1.1. Site Compatibility and Installation (section 3.5 Award Criteria of TD1. Request for tenders). In addition, during Phase 2 contractors will further define their deployment approach and coordinate pilot implementation requirements with the Procurers. Prior to Phase 3 deployment, contractors will have the opportunity to verify technical feasibility, infrastructure compatibility, spatial constraints, safety conditions and integration requirements at the assigned sites, as specified under GER1.2. Phase 3 Pilot Deployment (section 3.5 Award Criteria of TD1. Request for tenders).Contractors should therefore use the information and opportunities provided throughout Phases 1 and 2 to prepare for deployment. Where infrastructure adaptations are required, these will be addressed as part of the Phase 3 implementation planning to ensure that installation and commissioning can be completed within the contractual timeframe. b) As indicated in Annex 7. Phase 3 verification strategy & requirements, each solution shall be tested in two hospitals during Phase 3. Contractors should therefore be prepared to operate and support both pilot installations during the applicable testing and verification period. c) The contractor is responsible for organising and financing the performance testing activities required for Phase 3, including the engagement of an independent test body in accordance with the requirements set out in Annex 7. Phase 3 verification strategy & requirements and the ETV process. Performance data used for verification must be generated by the selected test body in compliance with the applicable requirements. The contractor remains responsible for coordinating these activities and providing all necessary operational support and access to the pilot installations.

The location of the contractor’s personnel or partners will not constitute a formal award or allocation criterion and cannot guarantee assignment to any specific hospital.The final allocation of the hospital sites will be communicated to the Phase 3 contractors during the transition from Phase 2 to Phase 3, specifically as part of the Third tender procedure (call-off for Phase 3). Please see section 2.1. Description of the services to be provided and 2.6 Time schedule of TD1. Request for Tenders The process follows these stages: Definition During Phase 2: Although the specific sites are implemented in Phase 3, they are defined during Phase 2 in close coordination with the procurers and relevant end users. Formal Confirmation: The selected testing locations for each contractor are confirmed during the transition period and reflected in the ETV Application file, the Specific Verification Protocol (SVP), and the Test Plan.Tender and Contractual Communication: The Third tender procedure (call-off for Phase 3) is scheduled to be launched in June 2028. Following the selection of winners, the final site requirements are formally embedded in the specific contracts for Phase 3, which are signed in July 2028.Testing Locations Phase 3 involves validating at least two final solutions across four EU Member States. Each solution must be tested in a minimum of two hospitals to ensure coverage of representative northern and southern European climatic conditions. The designated hospital sites are: HUN – Hospital Universitario de Navarra (Spain). AZM – Maastricht University Medical Center (Netherlands).PERH – Põhja-Eesti Regionaalhaigla (Estonia).WSS – Wojewódzki Szpital Specjalistyczny in Olsztyn (Poland)Please see Annex 1. Test Sites for more information.

The budget of up to €389,537.04 referred to in Section 2.5. Total budget and budget distribution (per phase) of TD1. Request for Tenders is reserved for infrastructure adaptations that may be required at the selected Phase 3 pilot sites.Tenderers are not required to include site-specific infrastructure adaptation costs in the TD9. Financial Form submitted as part of the Phase 1 tender. At the time of tender submission, the final allocation of pilot sites and the specific infrastructure requirements are not yet known.Infrastructure adaptation needs, where applicable, will be identified and assessed at a later stage based on the selected solutions, the assigned pilot sites, and the corresponding installation requirements. Relevant information on the identified adaptations and their implementation will be included in the Test Plan (see TD12. Generic test plan template). Any decision regarding the use and allocation of this budget will be made by the Procurers in accordance with the needs identified for the Phase 3 implementation.Please refer to Question 12 for more information.

-Do the cover pages and table of contents count towards the maximum page limits? Yes. Tenderers are requested to refer, for each document to be prepared, to the specific instructions set out in the relevant Tender Document (TD). The documents mentioned in the question, TD8 and TD9, contain explicit requirements regarding maximum length and formatting, and no exceptions or alternative arrangements are provided within those instructions. Accordingly, tenderers should comply with the requirements expressly stated in each Tender Document. -Does the pre-existing instructional text provided in the templates count towards the limit? Are we allowed to delete it to save space? Alternatively, if it must be retained, are we permitted to reduce its font size? Pre-existing instructional text provided in the templates counts towards the limit and elimination of sections and/or modifications of the templates are not allowed. Where the tender documentation does not provide specific derogations or exemptions, none should be assumed. This applies, among other aspects, to page limits, cover pages, tables of contents, instructional text included in the templates, bibliographies, reference sections, and font requirements. In addition, the templates provided as part of the tender documentation must be completed as issued. -Regarding the bibliography and references section, must it strictly adhere to the Calibri 11 font requirement, or is it acceptable to use a smaller font size for this specific part? Please refer to previous answer. The documents mentioned in the question, TD8 and TD9, contain explicit requirements regarding maximum length and formatting, and no exceptions or alternative arrangements are provided within those. Where the tender documentation does not provide specific derogations or exemptions, none should be assumed. This applies, among other aspects, to page limits, cover pages, tables of contents, instructional text included in the templates, bibliographies, reference sections, and font requirements.

The Financial Form (TD9) is provided as a template to be completed by tenderers. Therefore, tenderers are expected to provide the information expressly requested in the template (and in each field) while respecting the maximum length of 10 pages applicable to TD9. In this regard, the level of detail should be consistent with the structure of the tables included in TD9 and should not exceed what is necessary to complete them. These tables are intended to harmonise the manner in which financial information is presented, ensuring comparability between tenders and supporting a consistent assessment of the submitted information. For personnel costs, tenderers should provide the breakdown requested in the TD9 template, namely the personnel categories, applicable hourly rates, and the corresponding number of hours per phase. Where indicated in the template, personnel categories may be linked to the relevant phase. However, TD9 does not require a full breakdown by consortium partner and by individual staff member unless such information is specifically requested elsewhere in the form. Tenderers should therefore present the information in a manner that enables the contracting authority to understand the allocation of resources while remaining within the page limits established in TD9. The list of staff requested in the table should be completed in accordance with the instructions provided therein. For materials, subcontracting, and other cost categories, tenderers should provide the information requested by the relevant fields of the TD9 template. The purpose is to allow an assessment of the cost structure and the realism of the proposed budget. The information should be presented in a concise manner, aligned with the categories and tables included in TD9.

1)TD1, section 3.5 Award criteria, criterion A2.1, states:»In case adequately justified, suppliers may propose additional cytostatic compounds (…) beyond the above listed substances (as long as at least one (1) of the mandatory cytostatic drugs listed above is addressed).»2)Removal Rate Thresholds for Scoring Purposes:For contaminants included in an offer to be considered valid for scoring, they must meet the removal efficiency thresholds established in Section A1 (Removal Rates). The minimum required thresholds are as follows:-Cytostatic Drugs (A1.1): A removal efficiency of at least 80% is required. Scoring starts above this level: 0 points are awarded for 80% or less, 3 points for 81-90%, and 4 points for 91-100%.-Contrast Media (A1.2): The removal efficiency threshold must be at least 40%. Scoring is distributed as: 0 points for 40% or less, 2 points for 41-60%, 3 points for 61-80%, and 4 points for 81-100%.-Antibiotics (A1.3): A removal efficiency of at least 90% is required. 0 points are awarded for 90% or less, and 4 points for 91-100%.-Antimicrobial-Resistant Bacteria – ARB (A1.4): The threshold is at least 90% (log reduction). 0 points are awarded for 90% or less, and 4 points for 91-100%.-Antimicrobial Resistance Genes – ARG (A1.5): A removal efficiency of at least 90% is required. 0 points are awarded for 90% or less, and 4 points for 91-100%

The assessment of the Pass/Fail Award Criteria will be based exclusively on the information provided by the tenderer in Section 4 of TD8 (Technical Form), within the table provided for that purpose. Tenderers must therefore include in the relevant table field all information necessary to demonstrate compliance with the applicable requirement. Supporting evidence, such as references to scientific literature, validation tests, technical documentation or published data, may be included in the corresponding table entry where relevant (Please refer to TD8, Section 4). Please see also Question 11 for more information.

According to the Annex 7, Phase 3 focuses on validation in a real operational environment, follows a structured timeline to ensure proper setup and independent verification of the solutionsExplicitly, Phase 3 consists of the following stages:· Up to one (1) month of technical arrangements between hospitals, the Contractor, the Test Body, and the ETV Body IETU. This period covers agreements regarding the pilot location, installation conditions, access requirements, sampling arrangements, and the ETV application· Up to four (4) months of pilot installation, commissioning, and optimization· A minimum of three (3) months of pilot testing under real operational conditions to generate the necessary performance data· Up to one (1) month for the preparation and submission of the Test Report by the contractor· Verification reporting by the ETV Body IETU, which follows the assessment of the Test Report and the accepted test data to issue the final Verification Statement.

Sampling and laboratory analyses will be performed by SAS/CHV (or laboratories designated by them). All testing costs, except laboratory analyses, shall be borne by the Contractor. These costs include sampling consumables, logistics, transportation, storage, chain of custody and sample preparation. Laboratory analyses will be funded by SAS/CHV. Please check Section 2.1 of TD1.

Please refer to TD1, Section 3.5 (Weighted Award Criteria), page 76. The intention is not to introduce substantial changes to the procurement framework, but to allow limited adjustments based on the results obtained in the previous phase. The overall weighting between technical quality and price will not be modified. Any update or fine-tuning will be limited to the elements expressly identified in the tender documentation and may be introduced where justified by the outcomes of the previous phase.

For mandatory requirements that can only be fully demonstrated through prototype or pilot testing in Phases 2 or 3, final experimental evidence is not required at the initial tender stage. However, at Phase 1, the tenderer must instead provide sufficiently substantiated concept documentation demonstrating that the proposed solution has a credible technical basis and a feasible route to compliance. A general declaration or unsupported commitment to achieve compliance will not be sufficient. The evidence must enable the evaluators to conclude that the proposed solution is technically credible, coherent and capable of meeting the requirement during the relevant PCP phase. As an example, see TD1, section 3.5 Award criteria. PASS/FAIL AWARD CRITERIA, CRR 1.1. Cytostatics Removal (…) Suppliers are expected to provide a concise description of how their solution achieves the required removal in these particular contaminants, including the key treatment mechanisms, process steps, removal rates and any supporting evidence from published data, literature, technical specifications of the units processes, validated test results and/or technical documentation. (…) TD1, section 3.5 Award criteria. PASS/FAIL AWARD CRITERIA, CRR 1.2 Watersoluble, nephrotropic, low osmolar iodinated x-ray contrast media removal (…) Suppliers are expected to provide a concise description of how their solution achieves the required removal in these particular contaminants, including the key treatment mechanisms, process steps, removal rates and any supporting evidence from published data, literature, technical specifications of the units processes, validated test results and/or technical documentation.

The specifications listed in Annex 6, Section 20 represent the infrastructure the SAS Microbiology laboratory currently has available for prototype evaluation While Section 3.3 explicitly states that contractors electing to test at SAS premises «shall ensure compatibility» with these conditions, the documents allow for flexibility through an approval process. Prototypes requiring resources beyond the standard offering may be accepted, subject to the following mandatory conditions: -Prior Written Approval: Any requirements beyond the standard infrastructure must be subject to prior written approval by SAS. -Contractor Provision: The contractor is responsible for providing any additional infrastructure, utilities or auxiliary systems required for their prototype. -Documentation and Justification: These needs must be clearly specified in the test plan and technically justified. -Compatibility: SAS reserves the right to reject installation proposals that it deems fundamentally incompatible with the available infrastructure. If a prototype’s technical requirements are significantly beyond what the standard laboratory can accommodate, the contractor may justify testing at an alternative site where they can ensure the necessary infrastructure is available, provided SAS/CHV can still supervise the activities

The final selection of the pilot locations is made by the Public Buyers Group. The assigment will involve close coordination with the contractors during Phase 2 to define the sites. The selection is then formally confirmed during the transition from Phase 2 to Phase 3. The site allocation will ensure the coverage of representative northern and southern European climatic conditions relevant to the solution’s operating envelope. The available sites are: · Hospital Universitario de Navarra (Spain) · Maastricht University Medical Center (Netherlands) · Põhja-Eesti Regionaalhaigla (Estonia) · Wojewódzki Szpital Specjalistyczny in Olsztyn (Poland) Please see section 2.1. Description of the services to be procured and 2.6 Time schedule of TD1. Request for Tenders.

Annex 1 provides the baseline information currently available for each demonstration site, including infrastructure characteristics, utility availability, connection points and other relevant technical information. However, as indicated, certain parameters, particularly the concentrations of target contaminants, are currently unavailable for some hospitals. Throughout the PCP process, the Public Buyers Group will provide contractors with reasonable access to the relevant technical documentation available at each site. Furthermore, more detailed information on site-specific conditions and implementation requirements for Phase 3 will be included in the corresponding Call-Off documentation, to the extent that such information is available at that stage. Contractors will also be required to conduct site visits to verify technical feasibility, spatial constraints, infrastructure compatibility, operational conditions and safety requirements. Where specific effluent characterization data are not available from the hospital, any additional analyses required to support the proposed solution or substantiate performance claims shall be carried out and funded by the contractor. Please note what phase 3 (section 2.1 of TD1) states: «Please consider field testing in the four test site locations (suppliers need to consider in their budget for the phase at least 1 travel to each test site location). In the case a hospital doesn’t have any information about their effluent, suppliers have to take charge of this analysis, so they would need to pay for it For the preparation of initial proposals, bidders should rely on the information provided in the procurement documentation and adopt reasonable engineering assumptions where site-specific data are unavailable. All assumptions should be clearly identified and supported by estimates, calculations, scientific literature, previous testing experience or comparable technical references. Procurers will provide the best and most up-to-date site information available and will share any additional relevant information on an equal and transparent basis with all contractors. However, bidders remain responsible for clearly documenting their assumptions and verifying site-specific conditions, including any additional wastewater characterization required for the development and validation of their solutions.

The tender documents clarify that the expected TRL for the solution at the end of Phase 3 is within the range TRL 7-9, but the complete and integrated solution is not expected to reach TRL 9. The complete solution will be at lower TRL than 9, but some integrated parts maybe TRL9. (Please see TD1 Request for Tender section 2.1).

The procurement does not establish a single average flow rate that must be treated by all proposed solutions. As stated in Annex 6, Section 2.1, for phase 2 «The prototype capacity shall be functionally representative of the intended deployment configuration (centralised, decentralised, source-separated, polishing step, etc.) and sufficient to demonstrate full treatment performance and operational stability». Accordingly, it is the responsibility of each tenderer to determine and justify the treatment capacity of its proposed prototype, including demonstrating that the selected capacity is appropriate for generating representative performance data. In addition, Annex 7, Section 3.1 states that the objective for phase 3 is «The Phase 3 installation shall be a pilot-scale system representative of the intended deployment configuration, including where relevant». Tenderers are also required to define the nominal treatment capacity and operating range of their solution, including minimum and maximum flow conditions and allowable peak loads, in accordance with Requirement OPR1.1 and the related space and site integration requirements (SSI 1.4). For reference, Annex 1 provides the flow information currently available for the demonstration sites. Tenderers should use this information when preparing their proposals and clearly justify the flow rate selected for their prototype. Where a solution targets a specific source or wastewater stream within a hospital, the proposed treatment capacity may be based on that stream rather than on the total hospital effluent flow.

The problem that THERESA PCP aims to avoid with this request is twofold:1. Having two tenders unduly influenced by the same entity (facilitating collusive practices). 2. Having two tenders in which an entity has exceeded its capacity due to participation in several tenders. The easiest way for the Administrative Procurement Committee (APC) to check this double participation is indeed the registration number in the chamber of commerce (the NIF in Spain). I.e., an entity with a different identification number will be considered independent. However, if the participants from the same entity can demonstrate that they are under no means linked and working in completely different silos, they could be accepted. Different research teams or departments or researchers that belong to the same University or Research Institute and wish to present a tender joining different consortia should provide evidence that they are independent from each other by using a different identification number, different representative signing the declaration forms, etc. In addition, the statements can refer to relevant statutes or other relevant official documents to demonstrate, for example, that research teams belong to different departments. In the case of individual researchers, they may act independently with their personal identification number. For the sake of certainty and to avoid exclusions, any entity comprising multiple institutes/entities/researchers shall implement appropriate internal due diligence procedures to ensure the fair and transparent dissemination of this tender opportunity. Such entities must clearly inform all constituent institutes/entities/researchers of the tender and explicitly require that any participating institute demonstrate its factual and legal independence where applicable. In particular, participating entities must be able to substantiate that they operate and submit bids independently, including in terms of governance, decision-making, and representation. The use of the same authorised signatory for multiple submissions will be considered a strong indication of lack of independence. In such cases, unless duly justified and legally substantiated, the contracting authority reserves the right to exclude the affected tenders from the procedure to safeguard the principles of equal treatment, non-discrimination, and fair competition.

a) As indicated under 2.7 Intellectual Property Rights (IPR) of TD1 Request for Tenders «Each contractor will keep the ownership of the IPR attached to the results they generate during the PCP implementation». This includes the prototypes developed under phase 2. b) Please refer to section 2.1 Description of the services to be procured of TD1 Request for Tenders, stating «Each contractor or consortium shall allocate sufficient resources and include the costs of the Phase 2 testing activities in their budget proposal.» Please also refer to Annex 6. Phase 2 testing strategy & requirements. Under this annex it is clearly stated: «Role of the Contractor. The Contractor shall: · Develop, install and operate the prototype. · Propose and justify testing conditions. · Submit a Phase 2 test plan for approval. · Ensure safe operation and optimisation. · Cooperate with analytical laboratories; · Provide full access to operational data. · Bear all operational, consumable, shipment and waste handling costs.» Yes, contractor is expected to remove and recover the prototype from the testing site at the end of Phase 2. c) As indicated above, that is only possible if the PBG indicate it for phase 3. It is not a possibility under Phase 2. See section 2.1 Description of the services to be procured of TD1 Request for Tenders

Please refer to the answer provided to Question 10.

Please refer to the answers provided to Questions 8 and 29.

The final allocation of the hospital sites will be communicated to the contractors during the transition from Phase 2 to Phase 3, specifically as part of the call-off for Phase 3. Please see section 2.1. Description of the services to be provided and 2.6 Time schedule of TD1. Request for Tenders.The process follows these stages: · Definition During Phase 2: Although the specific sites are implemented in Phase 3, they are defined during Phase 2 in close coordination with the procurers and relevant end users. · Formal Confirmation: The selected testing locations for each contractor are confirmed during the transition period and reflected in the ETV Application file, the Specific Verification Protocol (SVP), and the Test Plan. · Tender and Contractual Communication: The Third tender procedure (call-off for Phase 3) is scheduled to be launched in June 2028. Following the selection of winners, the final site requirements are formally embedded in the specific contracts for Phase 3, which are signed in July 2028. Testing Locations Phase 3 involves validating at least two final solutions across four EU Member States. Each solution must be tested in a minimum of two hospitals to ensure coverage of representative northern and southern European climatic conditions. The designated hospital sites are: · HUN – Hospital Universitario de Navarra (Spain). · AZM – Maastricht University Medical Center (Netherlands). · PERH – Põhja-Eesti Regionaalhaigla (Estonia). · WSS – Wojewódzki Szpital Specjalistyczny in Olsztyn (Poland) Please see Annex 1. Test Sites for more information.

Please see section 3.3. Selection criteria of TD1 Request for Tenders, in particular selection criterion 4: “The CV (which can be from a different person that the previous one, i.e., IT IS POSSIBLE TO SUBMIT 2 DIFFERENT CVS TO COMPLY WITH THIS SELECTION CRITERION) should include at least 1 (one) project in the last 5 (five) years in which these elements were included.  
 
Compliance with this criterion may be demonstrated through the experience contained in one or two CVs, (no more than that) provided that all required expertise areas and project-related aspects are covered and clearly evidenced. The Tender Specifications do not provide for the combination of experience across more than two experts/CVs for the purposes of this criterion. 

General questions

1. What is an Open Market Consultation (OMC)?

An OMC is a preliminary market engagement process used in European public procurement. It is a structured dialogue between public procurers and the market (industry, suppliers, research organisations) conducted before launching a formal procurement procedure. The OMC allows public buyers to verify availability of solutions, assess market maturity and procure-ability of innovations, understand technological possibilities, and gather market capacity insights before designing their procurement strategy.

  • To reveal whether a solution meeting the need is already commercially available (and select the best procurement strategy).
  • To reveal the feasibility of developing a solution for the proposed unmet need and the Technology Readiness Level (TRL) of the components.
  • To inform the market, raise awareness, and invite participation in the OMC and the future tender.
  • To help forming consortia of suppliers.
  • To refine the tender scope, specifications, challenge definition and procurement strategy based on market feedback.
  • To identify barriers, enablers, state-of-the-art, and remaining R&D gaps.

The OMC helps public buyers understand market capabilities, identify potential solutions, and gather input to improve procurement design before launching formal procedures.

Anybody is welcome to participate in an OMC. Usual participants are  suppliers/industry, SMEs, start-ups and research organisations.

An OMC may include some or all the following activities:

  • PIN Publication: Publication of a Prior Information Notice (PIN) in the Official Journal of the EU (Tenders Electronic Daily – TED) to announce the upcoming procurement
  • Questionnaires: Launch of a written Request for Information (RFI) via EU Survey to gather structured feedback from market actors
  • Questions & Answers: Q&A platform published on the project website to address participant queries.
  • OMC Documentation: Comprehensive documentation including challenge description, requirements, and participation guidelines.
  • Events: Series of national and international workshops/webinars to present the project, explaining the PCP process.
  • Company pitches: included frequently in the planned events.
  • Bilateral Meetings: One-on-one consultation sessions with interested suppliers and research organizations.
  • Matchmaking Tool: Platform to facilitate consortium formation among potential participants.
  • OMC Dissemination: Distribution of promotional materials including FAQs and brochures about the OMC.
  • Analysis: Evaluation of market responses to refine challenge definition, specifications, and procurement approach.

No, participation is voluntary for suppliers, though it provides valuable insights into upcoming procurement opportunities. Participation in the OMC does not guarantee  participation in the upcoming tender (nor it is an eligibility consideration).

Discussions during the OMC should centre on market capabilities, technological possibilities, and high-level requirements, rather than on any procurement-specific details. Information gathered through the OMC may be used to inform the subsequent procurement process; however, this must be done in a transparent manner that avoids granting any unfair advantage to participants over non-participants.

  • A report summarising market capabilities, state-of-the-art, gaps, trends, and viable solution approaches.
  • A refined specification or challenge description for the upcoming tender.

A list or map of interested suppliers/consortia and potential match-making

OMC in the context of innovation procurement (PCP/Publis procurement of Innovative solutions – PPI) has a proactive innovation role: exploring whether R&D is needed and feasible, shaping the procurement challenge, engaging early with the market, understanding market dynamics. In standard procurement, market consultation may be more limited to supplying specifications or testing supply capacity.

OMCs are typically conducted in the early planning phases, well before launching the formal procurement procedure. While there is no fixed rule, good practice suggests several months ahead of the tender to allow proper market engagement, consortia formation and specification refinement.

The procuring authority should ensure that information provided by market participants is treated appropriately (careful balance between confidentiality and transparency and non-discrimination) and that future competition is not distorted. Some OMC documents include explicit IPR/confidentiality clauses.

In many PCP frameworks, Phase 0 is the initial preparation phase (including market consultation/OMC, needs analysis, drafting tender documents) before moving to the actual PCP which includes: Phase I (solution design), Phase II (prototype development), Phase III (pilot/validation). (procure-pcp.eu)

 

Yes, the involvement of SMEs, start-ups and new entrants to stimulate innovation and wide participation is encouraged.

The procurers typically provide: challenge description, objectives, expected user needs, rough timeframe, budget indications (if possible), legal/performance context as well as modes of participation; and invites market feedback on technological, organisational and commercial viability.

No. The feedback helps shape the procurement, but the procurer retains the decision-making power (e.g., what type of procurement to launch, final specifications, contract conditions). The OMC is a consultation tool and thus, not binding.

Pre commercial procurement

1. Presentations and recordings will be shared?

Yes, they will be shared and accessible through the webpage

Yes, you can submit another answer indicating that you are amending some sections

The questionnaire is based on a tool provided by the EC (EU Survey tool). It is an online tool. I.e., not available in word to fill by hand. 

Yes, you can register here: https://theresa-pcp.eu/matchmaking/

Not necessary, but if there is room, you are welcome to do so. However, we will prioritise the new companies who want to pitch.

Please note that suppliers are not warded a grant, but an R&D services contract. R&D covers fundamental research, industrial research and experimental development, as per the definition given in the EU R&D&I state aid framework. R&D does not include quantity production or supply to establish commercial viability or to recover R&D costs. It also excludes commercial development activities. The purchase of commercial volumes of products or services is not permitted.

The definition of R&D services means that the value of the total amount of products covered by the contract must be less than 50 % (fifty) of the total value of the PCP framework agreement:

  • The offers for all 3 Phases may include only products needed to address the challenge in question and to deliver the R&D services.
  • The total value of products offered in Phase 1 and in Phase 2 must be less than 50% (fifty) of the value of the Phase 1 and Phase 2 contracts’ value.

Tenders that go beyond the provision of R&D services will be excluded.

Please not that PCP Theresa aims to buy R&D services to develop a solution. R&D does not include quantity production or supply to establish the commercial viability or to recover R&D costs. It also excludes commercial development activities such as incremental adaptations or routine/periodic changes to existing products, services, production lines, processes or other operations in progress, even if such changes may constitute improvements. However, the contractors are expected to commercialize their results outside the PCP. Depending on the outcome of the PCP (whether it will result in innovative solutions that meet the tender requirements and offer best value for money), procurers may decide to follow-up the PCP with a Public Procurement of Innovative solutions (PPI).

It was a compendium of the different hospitals with common limitations. But in each event session, the local hospitals present their particular cases. This will be further detailied in the to-be-published tender documents.

At this stage of the Open Market Consultation, the available information regarding the participating hospitals has been published in the OMC documentation and event recordings available on our website: https://theresa-pcp.eu/repository/

Additional technical parameters are currently being finalized and this information will be included in the Request for Tenders documentation when it is officially published. To ensure equal treatment and transparency in accordance with public procurement principles, we cannot disclose unpublished technical specifications.

We recommend:

  • Review the OMC documentation thoroughly for currently available baseline information
  • Submit any clarification questions about already published information

 No. While advanced solutions based on installing a dedicated drainage network to collect and route wastewater from toilets in specific areas already exist, these are valid approaches and proposals including them are welcome. However, since this infrastructure is not technically or structurally feasible in all hospitals, the PCP also seeks novel approaches that can address those cases and broaden the range of facilities that can effectively treat and remove toxic substances from their wastewater. 

No, since the Open Market Consultation closed on February 28th.

technical aspects

1. This is the fourth meeting I have attended regarding the project. The goals are clear, and the targets are well-defined. However, the technical characteristics of each hospital are not included. For example, design flow, concrete concentrations, special needs, differences between the hospitals and their particularities, and the regulations of each country (not only EU compliance). Also, the locations to install the equipment in each case.

We are collecting this information. It is good to know what PRECISELY you want to know. 

Procedure

1. Partners, manufacturers: are these are obliged to be from the consortium countries only or any other EU country?

From any EU country, HE associated country or from countries beloning to the EEA.

As long as you, your consortium partners, your subcontractors and third parties on whose capabilities you may be relying on, comply with elegibility aspects, selection criteria and are under no exclusion grounds, you are free to choose with whom you participate. This will be detailed in the to be published Request for Tenders

This is not possible due to the rules. In order to arrange a meeting with the public buyers group, first fill the questionaire, and there you can ask for a bilateral meeting in order to solve any particular questions you may have. This procedure is in the OMC document.

It may be because of the captcha in the last section. Please, check that last bit and note that we need rigorous details about your solutions, general assessments will not help. And remember: we need QUALITY more than QUANTITY

Yes. A budget of €100,000 for each of the four hospitals has been allocated for the building and construction works in PCP Phase 3.

No. The suppliers selected for Phase 2 will verify their solutions in two hospitals, while in Phase 3 they will have the opportunity to validate them in two hospitals.

Tech development

1. As the hospitals that will be part of Phase 2 are already defined (CHV and HUVM), and the Prototypes will be built according to these hospitals needs, will the Phase 3 be implemented in the same hospitals?

In Phase 2, suppliers will be developing the prototype in SAS and CHV premises. Phase 2 prototypes have to demonstrate in lab conditions (SAS, CHV, HUVM) their capacity to remove the toxic substances specified in the requirements from the hospital wastewater, that will be described in the tender documents. Then we are testing the 2 final solutions in phase 3 in 4 different hospitals, 2 hospitals per solution.

Detailed information about the testing sites will be provided in the to-be-published tender documents

Phase 1 is the design of a solution. There is no testing at this early stage. Suppliers have to come up wih a proposal to address THERESA PCP challenge and the work for Phase 2 and Phase 3.

Under selection criteria, the Public Buyers Group will likely ask for previous project references in the field. But in principle it is not necessary that a solution is supported by prior data. Having said that, if a supplier grounds their solution on previously patented solutions, on data sets, data bases… Supplier will be asked to declare it and to ensure that you have full right to use those background information and that the Public Buyers Group will be able to use the solution based on said prior background information.

The set up of each hospital is very different. In each of the OMC sessions, the hospitals will give suppliers and interested market parties some insights to their needs and set up. This will be further clarified in the tender documents and in particular in the testing strategy.

This list of compounds is available in the EU Survey questionnaire. Feedback from the industry is needed in order to understand if the demands are reasonable.

It is not decided yet, it will depend on the location of the installation of the phase 3 pilot.

The THERESA PCP partners are not expecting anything unrealistic or technically unfeasible, but we do expect the proposed solutions to incorporate innovative approaches, particularly in terms of enhanced monitoring capabilities.

The solution should be scoped around the lowest-TRL components and the integration challenges, since combining individually mature components can still result in a low system-level TRL. Higher-TRL elements are treated as enabling technologies, while the PCP focuses on developing, validating, and de-risking whatever is needed to bring the overall solution to market readiness.

 In hospitals where the building layout allows it, installing a dedicated drainage network to route wastewater to a holding tank is a valid implementation pathway, with the exact technical design to be proposed by the contractor based on each facility’s conditions. However, this type of retrofit can involve significant structural modifications — replacing toilets, routing new piping through limited technical spaces, installing basement tanks — and in buildings where such interventions are not viable, implementation may not be possible. This remains an open limitation of the solution.