Clinical Evaluation for Medical Devices & IVD
Reliable clinical evidence for safe, complaint Market Access
What is Clinical Evaluation?
What is Clinical Evaluation?
Clinical Evaluation is a systematic, planned process for assessing whether the device is safe, performs as intended, and continues to meet regulatory requirements throughout the entire time on the market. In many jurisdictions, it’s a critical part of demonstrating conformity with applicable medical device regulations. Regulatory approval and market access now require robust clinical evidence under EU MDR, IVDR, and other global frameworks.
Purpose of Clinical Evaluation
The primary objectives of clinical evaluation are to:
- Verify that the device performs as intended by the manufacturer
- Confirm that the device doesn’t pose unacceptable risks to patients or users
- Demonstrate that the clinical benefits outweigh any residual risks
Clinical evaluations need to be updated throughout the lifetime of the device with clinical data obtained in the post-market phase.
How we can help
Qserve delivers Clinical Evaluation services that combine regulatory expertise, clinical rigor, and device‑only specialization to help manufacturers meet MDR/IVDR expectations. Our team of clinical experts is involved in clinical evaluation planning, systematic literature selection, appraisal, and review. We write your Clinical Evaluation Report (CER), and Post-Market Clinical Follow-Up plans (PMCF), and we guide your device lifecycle end-to-end, enabling you to achieve and keep regulatory compliance and market access.
Our CPS services cover multiple disciplines. Discover them:
Evaluation
We start by understanding your device, your existing clinical data, and your regulatory goals. This initial evaluation enables us to tailor a clinical evaluation strategy to your specific needs.
Clinical Evaluation planning & strategy
We define your clinical evidence requirements and determine whether new clinical studies are needed. Our strategic approach balances regulatory expectations, market access requirements, and operational efficiency.
Clinical Evaluation Plan (CEP)
We define the scope, methodology, and acceptance criteria for the evaluation, including the intended purpose, target population, and relevant safety and performance endpoints.
Literature search & appraisal
We conduct a systematic literature search and critically assess each source for scientific validity, relevance, and quality, ensuring your clinical evidence is comprehensive and robust.
Clinical Evaluation Report (CER)
We prepare detailed, audit-ready CERs that clearly demonstrate safety, performance, and benefit-risk. Reports are aligned with MDR/IVDR Annex requirements and are designed to withstand regulatory scrutiny.
Post-Market Clinical Follow-up Plan
We prepare a PMCF-plan that outlines the methods and procedures for pro-actively gathering and evaluating clinical data in the post-market phase.
Failing to address clinical evaluation requirements—such as providing insufficient clinical data, a poor clinical strategy, an incomplete literature review, missing PMCF plans, insufficient equivalence justification, or outdated CERs—can result in regulatory rejection, delayed CE marking approvals, or market access restrictions.
We apply a structured, audit-ready approach that starts early and stays aligned with your regulatory goals.
Failing to address clinical evaluation requirements—such as providing insufficient clinical data, a poor clinical strategy, an incomplete literature review, missing PMCF plans, insufficient equivalence justification, or outdated CERs—can result in regulatory rejection, delayed CE marking approvals, or market access restrictions.
We apply a structured, audit-ready approach that starts early and stays aligned with your regulatory goals.
Still have questions?
What is a Clinical Evaluation, and why is it required?
A Clinical Evaluation assesses clinical data todemonstrate a medical device’s safety and performance in its intended usepopulation. It’s a mandatory requirement under EU MDR, IVDR, and other globalregulations for regulatory submission.
Can we use existing clinical data from other regions?
Yes. If it is relevant, robust, reliable, and aligns with MDR/IVDR requirements, it must be critically appraised, systematically reviewed, and documented in a CER (Clinical Evaluation Report).
What is needed in the Clinical Evaluation process?
Many devices can rely on published literature, registry data, or post-market experience. Through meticulous planning, comprehensive data analysis, gap mitigation, and CER preparation, we help you maintain compliance and confidence from pre-market submission through post-market lifecycle.
How long does the clinical evaluation process take?
Timelines vary by device complexity and available data. From a few weeks or months for low-risk devices and legacy devices. The process and timelines mainly depend on the availability of clinical data as input to the clinical evaluation. If clinical trials, registries, or surveys are needed for novel or high-risk devices, the timelines are much longer.