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A Clinical Evaluation Report (CER) documents the clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of a medical device or the results of other studies on substantially equivalent devices. The CER demonstrates that the device achieves its intended purpose without exposing users and patients to further risk. Clinical evaluation reports are required for all medical devices in Europe. Medical device manufacturers must submit the CER to the notified body as an attachment to the European CE technical file. The technical file is an essential step to obtaining CE marking for a medical device, required to market medical devices in Europe.


The European Union (EU) is an economic and political union of 28 member states in Europe. It was founded in 1993 with the aim of creating a closer union between the peoples of Europe and has 23 official languages. The CE marking is mandatory for all products sold within the European Union that fall within the scope of CE marking directives.

There are three main directives for medical devices:

  • Medical Device Directive (93/42/EEC)
  • Active Implantable Medical Device Directive(90/385/EEC)
  • In Vitro Diagnostic Device Directive (98/79/EC)

Contents of technical documentation

  • Legal manufacturer and general information
  • Product description
  • Essential requirements (General Safety and Performance Requirements)
  • Manufacturing process
  • Risk management
  • Clinical data
  • Labeling
  • Device performance
  • Product specification
  • Special materials
  • Post-market surveillance
  • Declarations and certificates

Clinical Evaluation Overview

Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise, and analyze clinical data pertaining to a medical device, and to analyze whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s instructions for use. Clinical evaluation is conducted throughout the life cycle of a medical device as an ongoing process. Usually, it is first performed during product development to identify data needed for market access. Clinical evaluation is mandatory for initial CE marking and must be actively updated thereafter. Clinical evaluation is necessary and important because it ensures that the evaluation of the device’s safety and performance is based on sufficient clinical evidence throughout the lifetime that the medical device is on the market. This ongoing process enables manufacturers to provide notified bodies and competent authorities with sufficient clinical evidence for demonstration of conformity of the device with the Essential Requirements throughout its lifetime (for example for CE marking, fulfilment of post- market surveillance and reporting requirements, or during surveillance procedures).


Regulatory strategy for new product development


Regulatory compliance for sustenance

EU MDD to EU MDR2017745 transition

EU MDD to EU MDR2017/745 transition

Medical device regulatory strategy and phase-wise activity for new product development The regulatory strategy for NPD is carried out in three stages:


Feasibility assessment

Understanding the product and identifying applicable standards as per the intended purpose of the product.


Product development

Identifying applicable regulatory requirements and preparation of regulatory assessment report.


Product launch

Compiling the technical documentation, product registration, and launch.

Active update of the CER


  • Ratio benefit/risk profile, side effects and risk mitigation measures:-
    - Confirmation of safety and acceptance per current state-of-the-art clinical evaluation 
    - Accuracy/relevance of device information materials 
    - Accuracy of Post Market Surveillance (PMS) plan
  • Confirmation of existing claims
  • Justification of new claims


  • Frequency of CER defined and justified based on criteria (risk, innovation, changes)
  • If new information comes from the PMS, potentially impacting the current evaluation
  • If no new information comes from the PMS: 
    - Annually, if the device carries significant risk and or is not yet well established 
    -Every two to five years, if the device is not expected to carry significant risk and is well established


The clinical evaluation should be conducted by a suitably qualified individual or a team, taking into consideration:

  • Research methodology, information management, regulatory requirements, and medical writing knowledge
  • A qualified degree in the respective field and five years of documented professional experience; or 10 years of documented professional experience if a degree is not a prerequisite for a given task
  • Justification of choice of the evaluator(s)
  • Declaration of interest of each evaluator
  • Technical and scientific knowledge
  • Training and experience



Different Stages of Clinical Evaluation


WP - Overview of Clinical Evaluation for Medical Devices - 0423

CyARC: Cyient’s Accelerated Regulatory Compliance Offering

CyARC is a solution offering to accelerate the Regulatory Compliance process for regulated industries such as- Healthcare. It is an automated solution which intends to replace time taking manual and tedious processes and thereby speeding up time-to-market. CyARC’s intelligent framework utilizes NLP techniques and data clustering algorithms. Powered by a rule-based engine CyARC automatically generates pre-populated regulation checklists and templates, device-specific applicability assessments, and gap analysis. It offers the quickest way to provide design input to R&D engineers. CyARC’s digital database is designed to capture information and knowledge. Capable of scaling up, getting trained with user actions, and continuously improving, CyARC’s architecture is flexible and modular. Considering the state of the art, CyARC is one of the most promising solutions to fast-paced product development and sustenance.


cloud-based solution

A cloud-based solution to accelerate the regulatory compliance process. It helps to search worldwide regulations, and offers a digitized form regulation database for easy search and analysis. The standard module consists of a library of 1500+ international standards such as ISO/IEC/AAMI.


The solution offers a device classification tool, device-specific compliance, and regulatory intelligence services such as regulation assessment, gap assessment, and impact analysis.


Its regulatory watch feature monitors changes in regulations and provides a personalized news feed to users consisting of regulations news, safety communication, and warning letters.

Contents of a Clinical Evaluation Report

  • Executive Summary
  • Scope
  • State-of-the -Art Evaluation
  • Subject Device Description
  • Equivalence Study
  • Data Sources—Identification and Appraisal
  • Post-Market Experience and Surveillance
  • Risk Benefit Analysis
  • Conclusion

Challenges in Clinical Evaluation

  • Updated risk management data, where full risk management data are defined as delivery of the following: Risk analysis report + Failure Mode and Effects Analysis (FMEA) + Process Failure Mode and Effects Analysis (PFMEA) + Risk management report.
  • Biocompatibility reports.
  • Verification and validation (V&V) testing reports.
  • Full PMS data as an indication of an active PMS program, where full PMS data are defined as delivery of all the following: Sales + Complaints + Trend reporting + Corrective and Preventative Actions (CAPAs) if issued + Field Safety Corrective Actions (FSCAs) if applicable + PMCF data + data from registries.
  •  Technical documentation as per Annexes II and III to the MDR.
  • Copies of the instructions for use (IFU) and other applicable labeling documents.
  • Essential Requirement (ER)/General Safety and Performance Requirement (GSPR) checklists.
  •  Compliance with applicable standards.
  • Previously released CER, regardless of its compliance statement.



Most medical device companies are racing against time to ensure compliance to EU MDR-217/745 where clinical evaluation is critical. Cyient offers a one-stop solution for helping medical device companies with clinical evaluation for regulatory compliance. Empowered by our Quality Assurance and Regulatory Affairs (QARA) CoE, Cyient has certified professionals across all functions who have the required skill sets and expertise to support medical device companies throughout the clinical evaluation of medical devices.


About the Author

Abhishek Kumar is an SME in medical device regulatory and quality assurance services. With 12+ years of experience, he has successfully led multiple engagement programs for Europe, US, China, ASEAN markets for NPD and sustenance. Additionally, Abhishek has prepared and implemented the regulatory plan for NPD for 90+ countries by analyzing project feasibility, freezing regulatory requirements, and coordinating with various cross-functional teams.

About Cyient

Cyient (Estd: 1991, NSE: CYIENT) is a consulting-led, industry-centric, global Technology Solutions company. We enable our customers to apply technology imaginatively across their value chain to solve problems that matter. We are committed to designing tomorrow together with our stakeholders and being a culturally inclusive, socially responsible, and environmentally sustainable organization.

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