Call for expression of interest for medical device and in-vitro diagnostics medical devices experts (EXPAMED) and patient, consumer and healthcare professional experts (P&HCP)

The European Medicines Agency (EMA) has initiated a call for expression of interest, identified as EMA/2024/CEI/0011, aimed at establishing a pool of external experts across two designated lots: one for medical device and in-vitro diagnostics experts and the other for patient, consumer, and healthcare professionals. This opportunity falls within procurement contracts for services, specifically geared toward individual applicants rather than organizations.

The call encompasses two distinct lots: Lot 1 focuses on experts in medical devices and diagnostics, while Lot 2 is designed for patient and healthcare professional expertise. The aim is to recruit a diverse range of specialists who can provide advisory and regulatory services related to the EMA's projects. The contract duration is set for a maximum of 60 months. Importantly, applicants are required to submit individual applications per lot using a non-electronic method, adhering to guidelines specified in the provided procurement documents.

Geographically, the eligibility for applicants is primarily centered on EU membership or association, aligning with the norms for EMA contracts. While specific countries are not detailed, the operation emphasizes EU and EEA frameworks. The financial specifics concerning funding amounts remain unspecified but will follow standards consistent with EMA service contracts.

Key details include a single-stage application process and no co-funding requirements for selected experts. Although success rates are not indicated within the available information, the selection process emphasizes thorough evaluation criteria based on expertise and professional integrity.

This initiative invites professionals to contribute their knowledge and skills toward the evaluation and regulation of medical products, and it represents a pivotal opportunity within the healthcare and medical technology sectors. Interested applicants are encouraged to review the tender documents for comprehensive instructions, including submission requirements and eligibility criteria.

The European Medicines Agency (EMA) has issued a call for expression of interest, EMA/2024/CEI/0011, to establish a pool of experts in two distinct lots: medical device and in-vitro diagnostics medical devices experts (EXPAMED), and patient, consumer, and healthcare professional experts (P&HCP). This is a call for tenders. The TED reference is 170/2024 525420-2024.

The procedure type is a Call for Expression of Interest (CEI) for preselection of candidates. The estimated total value is not specified. The TED publication date was 02/09/2024. The lead contracting authority is the European Medicines Agency, MED. The main classification (CPV) code is 73000000, which refers to research and development services and related consultancy services.

Lot 1 focuses on medical device and in-vitro diagnostics medical devices experts (EXPAMED). The nature of the contract is for services, with a maximum contract duration of 60 months. The award method and estimated value are not specified. The lead contracting authority is the European Medicines Agency, MED, and a framework agreement will be used. The selection criteria include suitability to pursue the professional activity, economic and financial standing, and technical and professional ability, all detailed in the procurement documents. The main CPV code is 73000000, with an additional CPV code of 33000000 for medical equipment, pharmaceuticals, and personal care products.

Lot 2 focuses on patient, consumer, and healthcare professional experts (P&HCP). The description is a call for expression of interest for Patients and Health Care Professionals. The nature of the contract is for services, with a maximum contract duration of 60 months. The award method and estimated value are not specified. The lead contracting authority is the European Medicines Agency, MED, and a framework agreement will be used. The selection criteria include suitability to pursue the professional activity, economic and financial standing, and technical and professional ability, all detailed in the procurement documents. The main CPV code is 73000000.

Submissions must be sent exclusively to the address for submission given in the procurement documents, using a non-electronic submission method.

The available documents include:

Administrative Part- Corrigendum 1: Tender specifications - adm. part, published on 22/10/2024, Version 2, for all lots.
Annex 1: Technical Specifications Medical Devices Experts, published on 02/09/2024, Version 1, for Lot 1.
Annex 2: Technical Specifications P&HCP, published on 02/09/2024, Version 1, for Lot 2.
Annex 3A: Model Contract for Experts Group 1 Medical Devices, published on 02/09/2024, Version 1, for Lot 1.
Annex 4: Declaration of honour, published on 02/09/2024, Version 1, for all lots.
Annex 3B: Model Contract for Experts Group 2 P&HCP, published on 02/09/2024, Version 1, for Lot 2.
Annex 5: Data protection Notice, published on 02/09/2024, Version 1, for all lots.
Invitation - Admin Part Lot 1 and Lot 2, published on 06/06/2025, Version 1, for all lots.
Annex 6: Application Guidance, published on 06/06/2025, Version 2, for all lots.

Several questions and answers have been published regarding the call. It is clarified that the call is open only to individuals, not organizations. Separate applications are required for each lot. The application guidance can be found in Annex 6, and the conditions of the call are available on the EU Funding & Tenders Portal. The submission method is non-electronic, meaning applications cannot be submitted directly via the EU Funding & Tenders Portal.

Regarding technical aspects of the eSubmission system, it is recommended to use the latest versions of Google Chrome or Mozilla Firefox. Attachments should be less than 50 MB in size, and the maximum number of documents per tender is 200. The system supports all 24 official EU languages and uses UTF-8 character set encoding. The system encrypts all uploaded documents. A Personal Identification Code (PIC) is mandatory for participation.

In summary, this is a call for individuals with expertise in medical devices and in-vitro diagnostics, as well as patients, consumers, and healthcare professionals, to express their interest in becoming experts for the European Medicines Agency. The EMA is seeking to establish a pool of experts to provide services related to research and development in these areas. The call is divided into two lots, and applicants must submit separate applications for each lot they are interested in. The submission method is non-electronic, and applicants should consult the procurement documents for detailed instructions and requirements. The selected experts may be involved in various activities related to the evaluation and regulation of medical products.

Eligible Applicant Types: The call is open only to individuals. The call aims to establish a pool of experts.

Funding Type: The opportunity is a procurement, specifically a call for expression of interest for remunerated external experts.

Consortium Requirement: The opportunity is for single applicants only.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility is not explicitly stated, but based on the Q&A, it is advisable to consult the European Commission website and Annexes for details on conditions, implying a focus on EU or associated countries.

Target Sector: The program targets the health sector, specifically medical devices, in-vitro diagnostics, and patient, consumer, and healthcare professional expertise.

Mentioned Countries: No specific countries are mentioned, but the European Commission and the European Medicines Agency (EMA) are referenced, implying a focus on the EU.

Project Stage: The opportunity is for pre-selection of candidates to form a pool of experts, implying the experts will be involved in various stages related to medical device and healthcare product evaluation.

Funding Amount: The estimated total value is not specified. However, the experts will be remunerated, suggesting a variable funding amount based on the services provided.

Application Type: The application type is an open call for expression of interest.

Nature of Support: Beneficiaries will receive money in the form of remuneration for their expert services.

Application Stages: The number of stages is not explicitly mentioned, but it involves at least one stage of submitting an expression of interest, followed by a pre-selection process.

Success Rates: The success rates are not mentioned.

Co-funding Requirement: Co-funding is not required.

Summary:

This opportunity is a call for expression of interest by the European Medicines Agency (EMA) to establish a pool of external experts. The call is divided into two lots: one for medical device and in-vitro diagnostics medical device experts (EXPAMED), and the other for patient, consumer, and healthcare professional experts (P&HCP). The selected experts will be remunerated for their services. The application is open to individuals only, and the submission method is non-electronic. Applicants need to consult the procurement documents and Annexes for details on eligibility criteria, selection criteria, and the application process. The TED reference for this call is 170/2024 525420-2024, and the procedure identifier is EMA/2024/CEI/0011. The maximum contract duration is 60 months. The call aims to pre-select candidates to provide expertise in the evaluation and regulation of medical devices and healthcare products.