Study on market surveillance of products with embedded software

The European Innovation Council and SMEs Executive Agency (EISMEA) has announced an open call for tenders for a study focused on market surveillance of products with embedded software available in the EU market. The contract is estimated to be valued at €289,880, aiming to develop a robust inspection methodology for Market Surveillance Authorities (MSAs) to ensure product safety and compliance with EU legislation.

Eligible applicants include organizations with relevant expertise such as research institutes, consultancies, and legal or technical firms. The tender does not prioritize small and medium enterprises (SMEs) explicitly but does not restrict the size of applicants. The application type requires electronic submission through the EU Funding and Tenders Portal, with a deadline for receipt set for July 7, 2025. The award will be made based on the best price-quality ratio, with selection criteria focusing on the applicant's suitability to conduct professional activities, their financial standing, and technical ability.

The project is at the research and development stage, striving to enhance MSAs' operational capabilities regarding embedded software products. Geographic eligibility covers EU member states and potentially EEA countries, without specifying individual nations. The funding does not impose a co-funding requirement and follows a single-stage tendering process, which involves submission and evaluation.

No specific success rates are mentioned, but the competitive nature of EU tenders suggests that applicants may face significant competition. The call aims to foster collaboration and knowledge sharing among MSAs, driving improvements in the regulatory landscape for products containing embedded software.

Organizations must register for a Participant Identification Code (PIC) to apply. The electronic submission system allows for the upload of various document types, with specific requirements for file naming and size. The tender documents outline the necessary specifications and support compliance with various EU laws and obligations related to market surveillance processes.

The European Innovation Council and SMEs Executive Agency (EISMEA) has published an open call for tenders, EISMEA/2025/OP/0012, for a study on market surveillance of products with embedded software placed and available on the EU market. The TED reference for this call is 96/2025 322924-2025. The estimated total value of the contract is 289880 EUR. The TED publication date is 20/05/2025.

The general objective of the study is to ensure that products with embedded software on the EU market are safe and compliant with applicable legislation. The specific objective is to develop a robust inspection methodology for Market Surveillance Authorities (MSAs) that takes into account European legislation and the risks inherent to these types of products. This action aims to strengthen the operational market surveillance capacities of MSAs and foster their collaboration and knowledge-sharing. This procurement action falls under Section 2.8.2.6 of Annex I to the 2025 WP - Commission Implementing Decision C(2024)8194.

This is an open procedure, and the nature of the contract is for services. The maximum contract duration is 12 months. The award method will be based on the best price-quality ratio. There is no framework agreement associated with this tender.

The deadline for receipt of tenders is 07/07/2025 at 10:00 Europe/Brussels time. The date and time of the public opening is 07/07/2025 at 15:00 Europe/Brussels time. The contracting authority is not bound to reply to questions submitted after 26/06/2025 at 05:00 Europe/Brussels time.

Submissions must be sent exclusively via electronic submission at the address provided.

Selection criteria include:
Suitability to pursue the professional activity (consult the procurement documents).
Economic and financial standing (consult the procurement documents).
Technical and professional ability (consult the procurement documents).

The main classification (CPV) code is 79300000 - Market and economic research; polling and statistics.

The following documents are available for download:
ENTS Study - Products with embedded software final comments Technical specifications (Published 20/05/2025, Version 1, No translations available)
ENEN-Invitation to tender EISMEA2025OP0012 Study on market surveillance of products Invitation to tender (request for offer) (Published 20/05/2025, Version 1, No translations available)
ENAnnex 1-list of documents to be submitted EISMEA 2025 OP 0012 Other invitation to tender document (Published 20/05/2025, Version 1, No translations available)
ENAnnex 2-Declaration on honour-EISMEA2025OP0012 Declaration on honour (tender) (Published 20/05/2025, Version 1, No translations available)
ENAnnex 2.1-Statement of turnover-EISMEA2025OP0012 Other invitation to tender document (Published 20/05/2025, Version 1, No translations available)
ENAnnex 2.2 - technical capacity (EISMEA-2025-OP-0012) Other invitation to tender document (Published 20/05/2025, Version 1, No translations available)
ENAnnex 3-Power of attorney-EISMEA2025OP0012 Other invitation to tender document (Published 20/05/2025, Version 1, No translations available)
ENAnnex 4-List of identified subcontractors EISMEA2025OP0012 Other invitation to tender document (Published 20/05/2025, Version 1, No translations available)
ENAnnex 5 -Letter of submission EISMEA2025OP0012 Other invitation to tender document (Published 20/05/2025, Version 1, No translations available)
ENAnnex 5.1-Commitment letter subcontractor EISMEA2025OP0012 Other invitation to tender document (Published 20/05/2025, Version 1, No translations available)

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In summary, this is a call for tenders by EISMEA seeking a study on the market surveillance of products containing embedded software within the EU. The goal is to ensure these products are safe and compliant with EU laws. The study should develop a methodology for Market Surveillance Authorities to inspect these products effectively. The tender is open to any organization that meets the selection criteria related to professional activity, financial standing, and technical ability. The selected contractor will have 12 months to complete the study and will be awarded the contract based on the best price-quality ratio. The submission process is electronic, and all relevant documents and annexes must be submitted by the deadline. A Participant Identification Code (PIC) is mandatory for tenderers. The eSubmission system supports various file types and uses encryption to protect the confidentiality of the submissions.

Eligible Applicant Types: The eligible applicant types are not explicitly stated in the provided text. However, based on the nature of the tender, it is likely that eligible applicants include organizations with expertise in market research, economic analysis, and potentially legal or technical fields related to product safety and compliance. This could include research institutes, consulting firms, universities, and other entities with relevant capabilities. The selection criteria mention "Suitability to pursue the professional activity," "Economic and financial standing," and "Technical and professional ability," suggesting that the applicant must be a legal entity capable of fulfilling the contract requirements.

Funding Type: The funding type is procurement, specifically an invitation to tender (request for offer) for services. The contracting authority is seeking a service provider to conduct a study.

Consortium Requirement: The text does not explicitly state whether a consortium is required or if a single applicant is sufficient. However, the presence of "Annex 4-List of identified subcontractors" and "Annex 5.1-Commitment letter subcontractor" suggests that applicants may involve subcontractors, implying that both single applicants and consortia could be eligible.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility is not explicitly defined, but the study focuses on products placed and available on the EU market. This suggests that applicants from the EU and potentially EEA countries are eligible. The call aims to strengthen the operational market surveillance capacities of Market Surveillance Authorities (MSAs), which operate within the EU framework.

Target Sector: The target sector is market surveillance of products with embedded software. This encompasses aspects of ICT, software services, manufacturing, and regulatory compliance. The study aims to ensure the safety and compliance of these products with European legislation.

Mentioned Countries: No specific countries are mentioned, but the focus is on the EU market, implying that the study and its outcomes are relevant to all EU member states.

Project Stage: The project stage is research and development, specifically focused on developing a robust inspection methodology. The tender is for a study, indicating an early stage of development rather than commercialization or scale-up.

Funding Amount: The estimated total value of the tender is 289,880 EUR.

Application Type: The application type is an open call for tenders, with electronic submission.

Nature of Support: The beneficiaries will receive money in exchange for services rendered, specifically for conducting the study on market surveillance of products with embedded software.

Application Stages: The number of application stages is not explicitly stated, but it involves at least one stage of submitting a tender, which will then be evaluated based on the selection criteria outlined in the procurement documents.

Success Rates: The success rates are not mentioned in the provided text.

Co-funding Requirement: The text does not explicitly mention a co-funding requirement.

Summary:

This is an open call for tenders issued by the European Innovation Council and SMEs Executive Agency (EISMEA) for a study on market surveillance of products with embedded software available on the EU market. The primary goal is to develop a robust inspection methodology for Market Surveillance Authorities (MSAs) to ensure the safety and compliance of these products with European legislation. The estimated total value of the contract is 289,880 EUR, and the maximum contract duration is 12 months.

The tender is open for electronic submissions, and the deadline for receipt of tenders is July 7, 2025. The contracting authority will not reply to questions submitted after June 26, 2025. The award method is based on the best price-quality ratio.

The tender documents include technical specifications, the invitation to tender, a list of documents to be submitted, declarations of honor, statements of turnover, evidence of technical capacity, power of attorney, lists of subcontractors, letters of submission, and commitment letters from subcontractors.

The study falls under the broader objective of strengthening the operational market surveillance capacities of MSAs and fostering collaboration and knowledge-sharing among them. The successful tenderer will be responsible for developing a methodology that considers European legislation, the obligations of manufacturers, and the risks associated with products containing embedded software.

To participate, organizations must register for a Participant Identification Code (PIC). The eSubmission system supports various file types and has specific requirements for attachment names and sizes (files must be less than 50 MB, and a maximum of 200 files can be uploaded per tender). The system supports all 24 official EU languages and uses encryption to ensure the integrity and confidentiality of information.