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Clinical Trials

End-to-end clinical investigation management for medical devices and IVDs under EU MDR/IVDR.

Clinical Investigation Management

Clinical trials for medical devices are essential for demonstrating safety and performance, and are a key requirement under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).

Our team of clinical research professionals manages the entire clinical trial lifecycle, from feasibility assessment and protocol design through to the final clinical study report and regulatory submission.

We work with medical device manufacturers, IVD companies, and MedTech innovators across Europe to generate robust clinical evidence supporting CE marking and market access.

Why Choose CEHP for Clinical Trials?

  • Deep expertise in MDR/IVDR clinical requirements
  • Experienced clinical operations team
  • Pan-European site network
  • Integrated regulatory and clinical strategy
  • Efficient study timelines and cost management
  • Full transparency and regular reporting

Our Clinical Trial Services

Study Planning & Design

  • Feasibility assessment and study design
  • Protocol development (ISO 14155 compliant)
  • Statistical analysis plan
  • Case report form (CRF) design
  • Informed consent document preparation

Regulatory & Ethics

  • National competent authority submissions
  • Ethics committee applications
  • EUDAMED clinical investigation registration
  • Substantial amendment management

Study Execution

  • Investigator and site selection
  • Site initiation, monitoring, and close-out visits
  • Clinical data management
  • Safety reporting and pharmacovigilance
  • Quality assurance and audit readiness

Reporting & Submission

  • Biostatistical analysis
  • Clinical study report (CSR) authoring
  • Clinical evaluation report integration
  • Regulatory submission dossier support
  • Notified Body liaison

Post-Market Clinical Follow-up (PMCF)

  • PMCF plan development
  • PMCF study design and execution
  • Registry-based studies
  • Real-world evidence generation
  • PMCF evaluation report

All services are conducted in strict accordance with Regulation (EU) 2017/745 and Regulation (EU) 2017/746, as well as with all applicable national legislation. Our objective is to ensure that every study conducted in Bulgaria meets the highest ethical, scientific, and regulatory requirements, enabling manufacturers to generate robust, reliable evidence while benefiting from an efficient and supportive environment.

Why Choose Bulgaria for Your Clinical Trials

Regulatory and Administrative Environment

  • Bulgaria offers a stable and predictable regulatory environment fully aligned with European Union standards, enabling faster and smoother approval and study start-up compared to many other countries.
  • The Bulgarian Drug Agency, also acting as a Notifying Body, is ensuring adherence to the highest international requirements for quality, safety, ethics, and regulatory compliance.

High-Quality Medical Workforce

  • Clinical trials in Bulgaria are conducted by competent, experienced, and well-trained healthcare professionals, many of whom hold international certifications.
  • Rigorous protocol compliance and consistently high-quality data are well-recognized strengths of Bulgarian clinical research sites.

Financial and Economic Benefits

  • Bulgaria offers highly competitive operational costs for conducting clinical trials compared with Western Europe including lower site-related expenses.
  • Clinical trials generate economic value by attracting investment, creating jobs, and providing additional income to medical institutions and professionals.

Access to Patients and Innovations

  • The centralized healthcare system, strong clinical infrastructure, and large regional medical centers allow for efficient and rapid patient recruitment across a wide range of medical conditions.
  • Patients benefit from early access to innovative technologies and advanced healthcare services that may not otherwise be available.
  • Universal healthcare coverage and a sizeable, diverse population facilitate recruitment across multiple demographics and therapeutic areas.

Scientific Advancement and Know-How Transfer

  • Conducting clinical research in Bulgaria promotes scientific exchange, collaboration with international partners, and continuous professional development for local investigators.
  • Clinical trials help elevate clinical standards and strengthen Bulgaria's overall scientific and research capacity in the MedTech field.

Patient Rights and Safety

  • Bulgaria provides a strong ethical and regulatory framework that ensures robust protection of patient rights, safety, privacy, and voluntary participation, supported by transparent oversight mechanisms.

Dedicated CRO Expertise

  • CEHP is an organization dedicated to clinical trials of medical devices and in vitro diagnostic medical devices operating in Bulgaria, working in close cooperation with the Bulgarian Medical Association to ensure professional, compliant, and efficient study execution.

These strengths make Bulgaria an attractive, reliable, and competitive location for international clinical trials of MedTech innovations.

Beyond Clinical Trials — Additional Services

Comprehensive regulatory, technical, clinical, and post-market support

Technical Documentation and Regulatory Support

  • Full Technical Documentation preparation for conformity assessment under MDR 2017/745 and IVDR 2017/746
  • Support and coordination with Notified Bodies, including direct communication with a Notified Body in Poland
  • Clinical Evaluation Report (CER) preparation and updates according to MDR
  • Updating of Biological Evaluation documentation according to ISO 10993-1
  • Preparation of complete CE marking documentation packages

Post-Market Surveillance (PMS) Services

  1. PMS Plans
  2. PMS Reports
  3. PSURs
  4. PMCF Plans
  5. PMCF Reports

EU Market Access and HTA

  • Health Technology Assessment (HTA) preparation under Regulation (EU) 2021/2282
  • Support for early access and EU market-entry strategies
  • Preparation of strategies, programs and documentation for reimbursement of medical devices and in vitro diagnostic devices by state and public institutions in Bulgaria

All activities strictly comply with European legislation, ensuring robust evidence generation, scientific quality, regulatory alignment, and efficient project execution.

Ready to Start Your Clinical Program?

Contact our team to discuss your clinical trial needs and how we can support your path to CE marking.

Get in Touch