An Overview of Clinical Evaluation for Medical Devices Clinical evaluation is mandatory for EU MDRcompliance and for obtaining the CE markingrequired for sale of medical devices in Europe.

Introduction

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).

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

Active update of the CER

WHY

• 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

WHEN

• 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

WHO SHOULD PERFORM THE CLINICAL EVALUATION?

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

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.

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

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.