Summary
- Closed for EoI
- Profile Type
- Business request
- POD Reference
- BRGB20251128018
- Term of Validity
- 28 November 2025 - 28 November 2026
- Company's Country
- United Kingdom
- Type of partnership
- Commercial agreement
- Targeted Countries
- Belgium
- Finland
- Cyprus
- Greece
- Austria
- Denmark
- Germany
- Bulgaria
- Croatia
- France
- Czechia
- Estonia
- Luxembourg
- Slovakia
- Netherlands
- Portugal
- Malta
- Lithuania
- Slovenia
- Ireland
- Latvia
- Hungary
- Poland
- Sweden
- Spain
- Italy
- Romania
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General information
- Short Summary
- A UK based SME specialising in women’s health biotechnology is seeking collaboration with EU-based regulatory organisations or authorised representatives to support CE-marking and ensure compliance with the In Vitro Diagnostic Regulation (IVDR). The company has developed a UKCA-marked digital diagnostic that predicts preeclampsia risk from routine blood tests. It now aims to establish a long-term partnership to facilitate EU certification and market entry.
- Full Description
-
A biotechnology SME from the United Kingdom develops diagnostic and therapeutic innovations targeting pregnancy-related complications, particularly preeclampsia.
The company has developed a Software-as-a-Medical-Device (SaMD) that predicts preeclampsia risk by analysing routine biochemical data collected during standard antenatal care. The algorithm uses results from hospital or laboratory systems to generate a rule-in diagnostic result, enabling early identification of at-risk pregnancies before clinical symptoms occur.
The product holds UK Conformity Assessed (UKCA) marking as a General In Vitro Diagnostic (IVD) under the UK Medical Devices Regulations 2002. The next development phase involves obtaining CE-marking and ensuring full compliance with the EU In Vitro Diagnostic Regulation (IVDR).
The company is looking for regulatory cooperation with established EU-based organisations capable of providing regulatory guidance, technical documentation review, and representation during the CE-marking and IVDR conformity assessment process. The ideal partner will act as, or facilitate contact with, an EU Authorised Representative.
The collaboration will include:
• Preparation and submission of technical documentation for CE-marking.
• Review and alignment of quality management system (QMS) documentation to IVDR standards.
• Coordination with notified bodies and regulatory authorities.
• Post-market surveillance and vigilance planning for ongoing compliance.
• Strategic advice on future product extensions and regulatory lifecycle management.
By engaging with experienced regulatory partners, the company aims to accelerate certification, ensure regulatory continuity, and establish a robust foundation for its expansion into the European market. - Advantages and Innovations
-
• The product is the first digital rule-in diagnostic for preeclampsia, predicting disease risk before clinical symptoms occur.
• Uses existing blood test data, requiring no new laboratory reagents or assays.
• Fully cloud-based and GDPR-compliant, interoperable with hospital Laboratory Information Systems (LIS) and Electronic Health Records (EHR).
• Already UKCA-marked and supported by clinical validation studies demonstrating high predictive accuracy. - Technical Specification or Expertise Sought
-
The partner should have:
• Proven expertise in IVDR and CE-marking processes for medical devices and Software-as-a-Medical-Device (SaMD).
• Capability to act as, or collaborate closely with, an EU Authorised Representative.
• Experience liaising with EU-notified bodies for conformity assessments.
• Knowledge of regulatory requirements for digital health and diagnostic software products.
• Capacity to provide strategic and operational support in documentation, compliance, and regulatory submissions. - Stage of Development
- Available for demonstration
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- IPR status
- IPR granted
- IPR notes
- Protected under proprietary algorithm and software copyright. Trademark registered in the United Kingdom.
Partner Sought
- Expected Role of a Partner
-
Regulatory consultancy firms, notified body liaison services, or authorised representatives based in the European Union with proven experience in IVDR compliance for in vitro diagnostics and digital health products.
Role of partner:
• Provide regulatory and compliance expertise for CE-marking and IVDR certification.
• Serve as, or support the appointment of, an EU Authorised Representative.
• Advise on technical documentation, clinical evidence requirements, and post-market obligations.
• Ensure efficient communication with notified bodies and competent authorities. - Type and Size of Partner
- SME <=10
- Other
- SME 50 - 249
- SME 11-49
- Big company
- Type of partnership
- Commercial agreement
Dissemination
- Market keywords
- 05001002 - In-vitro diagnostics
- Targeted countries
- Belgium
- Finland
- Cyprus
- Greece
- Austria
- Denmark
- Germany
- Bulgaria
- Croatia
- France
- Czechia
- Estonia
- Luxembourg
- Slovakia
- Netherlands
- Portugal
- Malta
- Lithuania
- Slovenia
- Ireland
- Latvia
- Hungary
- Poland
- Sweden
- Spain
- Italy
- Romania