Clinical Evaluation
During your medical device journey to market, you must produce and maintain a Clinical Evaluation Report (CER) that complies with Article 61 and Part A of Annex XIV of Medical Devices Regulation (MDR) 2017/745. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device and evaluation of clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the your medical device Instructions for Use. Clinical Evaluation Plan create the framework to assess the medical device and ultimately resulting in the Clinical evaluation reports.
The purpose of the Clinical Evaluation Plan is to highlight how the manufacturer is intending to plan, conduct and update a clinical evaluation. The output of the Clinical Evaluation Plan will be detailed within the Clinical Evaluation Report to state clinical benefits, safety characteristics of the device and performance requirements based on clinical data.
The Clinical Evaluation Report will be thorough and objective and take into account both favourable and unfavourable data.
Clinical Evaluation Plan
In accordance with Article 5.3, demonstration with the general safety and performance requirements shall include a clinical evaluation in accordance with article 61. The general safety and performance requirements which require the clinical evaluation to demonstrate conformity.
The following are planned to be assessed:
General Safety and Performance Requirements (GSPR)
Device Information
Clinical evaluation strategy
Clinical data sources
Benefit-risk analysis
Post Market Clinical Follow-up(PMCF) Review
Clinical Evaluation Report
The scope of this Clinical Evaluation Report is to demonstrate conformity of the device with the General Safety and Performance Requirements (GSPR) of EU MDR 2017/745, specifically those requiring clinical evaluation under Article 61 and Annex XIV. The CER assesses the safety, clinical performance, and benefit–risk profile of the medical device under evaluation.
The evaluation focuses on:
The intended purpose and target population
Identification and assessment of known and foreseeable risks
Confirmation that clinical benefits outweigh residual risks
Alignment with the current state of the art
The CER demonstrates MDR conformity by systematically reviewing non‑clinical evidence, scientific literature, and state‑of‑the‑art data to confirm that the device is safe, performs as intended, and has an acceptable benefit–risk profile for its intended professional use.
Frequently Asked Questions
Is Clinical Evaluation required for medical device registration?
A Clinical Evaluation is a structured, documented assessment of clinical data to demonstrate that a medical device achieves its intended clinical benefits and meets safety and performance requirements when used according to the IFU. Under EU MDR (Article 61 and Annex XIV), a compliant Clinical Evaluation Report (CER) is mandatory for CE and UKCA marking and must be maintained throughout the device lifecycle.
What types of clinical data are used in a Clinical Evaluation?
Clinical Evaluations draw on a combination of pre‑market and post‑market data, which may include clinical investigations, published literature, equivalent or similar device data (where justified), post‑market surveillance (PMS), post‑market clinical follow‑up (PMCF), and complaint or vigilance data. All data are appraised for scientific validity, relevance, and adequacy against defined criteria.
Do all medical devices need a Clinical Evaluation?
Yes. All medical devices, regardless of class, require a Clinical Evaluation under EU MDR. The depth and complexity depend on the device classification, risk profile, novelty, and availability of existing clinical evidence. Higher‑risk and implantable devices typically require more extensive clinical evidence and ongoing PMCF activities.
What is the difference between a Clinical Evaluation Plan (CEP) and a Clinical Evaluation Report (CER)?
The Clinical Evaluation Plan (CEP) defines how the evaluation will be conducted, including scope, clinical strategy, data sources, appraisal criteria, and analysis methods. The Clinical Evaluation Report (CER) documents the outcomes of that process, presenting the critical appraisal, analysis, and conclusions on safety, performance, and benefit–risk in line with MDR requirements.
When does a Clinical Evaluation need to be updated?
Clinical Evaluations are living documents and must be reviewed and updated regularly. Updates are required when new clinical data become available, following significant design or manufacturing changes, changes in intended use, safety signals from PMS/PMCF, or updates to the state of the art. Regular review is essential to demonstrate ongoing MDR compliance.