Clinical Evaluation
of Medical Devices
TentaConsult Italia supports medical device manufacturers, biomedical companies, and healthcare organizations in the preparation, maintenance, and management of clinical evaluation activities in compliance with Regulation (EU) 2017/745 (MDR).
From the development of the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER) to Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities, we assist companies in the collection and assessment of clinical evidence, scientific literature reviews, and the continuous updating of MDR technical documentation.
What is the Clinical Evaluation of medical devices?
The clinical evaluation of a medical device is a systematic and documented process aimed at demonstrating the device’s safety, clinical performance, and benefit-risk profile throughout its entire lifecycle.
Regulation (EU) 2017/745 (MDR) requires clinical evaluation to be planned, documented, and continuously maintained through an ongoing process based on:
- Clinical data
- Scientific evidence
- Published scientific literature
- Post-market surveillance (PMS) data
- PMS and Post-Market Clinical Follow-up (PMCF) activities
Clinical evaluation is a core component of MDR technical documentation and represents one of the key elements assessed during conformity assessment and regulatory compliance activities.
TentaConsult Italia supports medical device manufacturers and healthcare organizations in managing clinical and regulatory activities through a technical, documentation-driven, and compliance-focused approach.
Clinical Evaluation according to MDR 2017/745
Requirements of Regulation (EU) 2017/745
The Medical Device Regulation (MDR) introduced more stringent requirements for the clinical evaluation of medical devices, requiring manufacturers to continuously demonstrate the safety, clinical performance, and benefit-risk profile of their devices throughout the product lifecycle.
Article 61 of the MDR establishes the requirements for clinical evaluation and specifies that clinical evidence must be appropriate to the device’s risk class, intended purpose, and specific characteristics.
MDR compliance requires:
- Periodic updates of the clinical evaluation
- Integration of post-market data into the clinical evaluation process
- Collection and analysis of clinical evidence
- Consistency between technical documentation, the Clinical Evaluation Report (CER), Post-Market Surveillance (PMS), and Post-Market
- Clinical Follow-up (PMCF) documentation
- Continuous monitoring of the device’s benefit-risk profile
TentaConsult Italia supports medical device manufacturers and healthcare organizations in aligning their clinical documentation with MDR requirements, helping reduce the risk of regulatory non-compliance and supporting successful conformity assessment processes.
Clinical Evaluation Plan (CEP)
Preparation of the Clinical Evaluation Plan
The Clinical Evaluation Plan (CEP) defines the methodology, strategy, and criteria used to conduct the clinical evaluation of a medical device.
The CEP is a fundamental component of MDR technical documentation and must be developed in alignment with:
- The intended purpose of the device
- Its clinical and functional characteristics
- Applicable safety and performance requirements
- The current state of the art
- Available clinical data and evidence
- The Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) strategy
TentaConsult Italia supports manufacturers in the preparation, review, and maintenance of Clinical Evaluation Plans in accordance with MDR requirements and applicable guidance documents, ensuring a structured methodological approach that is fully aligned with the device’s technical documentation.
Clinical Evaluation Report (CER)
Preparation and Maintenance of the CER
The Clinical Evaluation Report (CER) documents the outcomes of the clinical evaluation process and demonstrates that the medical device meets the applicable requirements for safety, clinical performance, and regulatory compliance under the MDR.
The CER typically includes:
- Analysis of available clinical data
- Evaluation of clinical evidence and scientific data
- Systematic literature review and appraisal
- Benefit-risk assessment
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) data
- Clinical conclusions regarding the device’s conformity with applicable MDR requirements
Maintaining an up-to-date CER is an ongoing regulatory requirement and a critical element in ensuring continued compliance throughout the device lifecycle.
TentaConsult Italia supports manufacturers in the preparation, review, and updating of Clinical Evaluation Reports through a technical and regulatory approach focused on scientific robustness, documentation completeness, and MDR compliance.
Literature review and state of the art assessment
Collection and Evaluation of Clinical Evidence
The collection of clinical evidence is one of the most critical components of the clinical evaluation process.
A comprehensive literature review enables manufacturers to:
- Identify relevant scientific publications
- Assess the current state of the art
- Evaluate available clinical data and evidence
- Support the demonstration of device safety and clinical performance
- Integrate clinical evidence into the Clinical Evaluation Report (CER)
TentaConsult Italia supports medical device manufacturers in conducting scientific literature searches, publication screening, literature appraisal, and critical evaluation of clinical evidence in accordance with MDR requirements and applicable clinical evaluation guidance.
PMS e PMCF
Post-Market Surveillance in Compliance with MDR
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities are essential for monitoring the safety, performance, and clinical benefit-risk profile of a medical device after it has been placed on the market.
The MDR requires manufacturers to establish a continuous system for collecting and analyzing post-market data in order to:
- Monitor device safety and clinical performance
- Identify trends, emerging risks, and potential issues
- Collect and assess market feedback
- Evaluate incidents, complaints, and adverse events
- Update the clinical evaluation and benefit-risk assessment
PMS and PMCF activities typically include:
- PMS Plan
- PMS Report or Periodic Safety Update Report (PSUR), where applicable
- PMCF Plan
- PMCF Evaluation Report
- Integration of post-market clinical data into the Clinical Evaluation Report (CER)
TentaConsult Italia supports medical device manufacturers in the planning, implementation, and management of PMS and PMCF activities, ensuring effective integration of post-market clinical evidence into MDR technical documentation and ongoing regulatory compliance.
MDR Support and Technical Documentation
TentaConsult Italia provides specialized support for the management of clinical and regulatory documentation in accordance with Regulation (EU) 2017/745 (MDR).
Our services include:
- Clinical evaluation of medical devices
- Preparation and maintenance of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER)
- Clinical evaluation updates throughout the device lifecycle
- Scientific literature reviews and clinical evidence assessment
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
- Collection and analysis of post-market data
- Support for MDR technical documentation
- Regulatory Affairs support
- Documentation updates for Class I medical devices
Our consulting approach is focused on regulatory compliance, documentation quality, and the effective management of clinical and regulatory requirements throughout the product lifecycle.
You may also be interested in
FAQ
What is the clinical evaluation of a medical device?
Clinical evaluation is a documented and systematic process used to demonstrate the safety, clinical performance, and regulatory compliance of a medical device through the assessment of clinical data, scientific evidence, and post-market information in accordance with MDR requirements.
What is the difference between a CEP and a CER?
The Clinical Evaluation Plan (CEP) defines the methodology, objectives, and strategy for conducting the clinical evaluation. The Clinical Evaluation Report (CER) documents the results of the evaluation, including clinical data analysis, evidence appraisal, benefit-risk assessment, and conclusions regarding the device’s conformity.
Is clinical evaluation mandatory under the MDR?
Yes. Regulation (EU) 2017/745 (MDR) requires manufacturers to perform and maintain a clinical evaluation as an integral part of the technical documentation for medical devices.
When should a CER be updated?
The CER must be reviewed and updated periodically throughout the device lifecycle and whenever new clinical data, PMS or PMCF findings, safety information, or significant device changes become available.
What is PMS in medical devices?
Post-Market Surveillance (PMS) is the system established by manufacturers to proactively collect, analyze, and evaluate data on a medical device after it has been placed on the market, supporting the ongoing assessment of safety and performance.
What is PMCF?
Post-Market Clinical Follow-up (PMCF) is a continuous process of collecting and evaluating clinical data from real-world use of a medical device after market placement to confirm its safety, clinical performance, and benefit-risk profile.
What does Article 61 of the MDR cover?
Article 61 of Regulation (EU) 2017/745 establishes the requirements for clinical evaluation and defines the clinical evidence necessary to demonstrate a device’s conformity, safety, and clinical performance.
Why is the collection of clinical evidence important?
Clinical evidence provides the foundation for demonstrating compliance with MDR requirements and supports the assessment of a device’s safety, clinical performance, and benefit-risk profile.
Does MDR technical documentation need to be updated?
Yes. MDR technical documentation must be maintained and updated throughout the entire lifecycle of the medical device, incorporating new clinical evidence, PMS and PMCF data, and other relevant post-market information.
Do Class I medical devices require a clinical evaluation?
Yes. Class I medical devices must also have a clinical evaluation that complies with MDR requirements and is appropriate to the device’s intended purpose, characteristics, and associated risks.