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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

MDR-compliant Clinical Evaluation Plan checklist

You can use our MDR-compliant Clinical Evaluation Plan checklist to streamline your clinical evaluation process, ensure regulatory compliance, and simplify documentation for EU submissions.

MDR-compliant Clinical Evaluation Plan checklist

You can use our MDR-compliant Clinical Evaluation Plan checklist to streamline your clinical evaluation process, ensure regulatory compliance, and simplify documentation for EU submissions.

A Clinical Evaluation Plan is needed to outline the strategy and methods for demonstrating the safety and performance of a medical device, ensuring compliance with MDR requirements.



Fill out the Device field, check the checkboxes for available requirements and N/A boxes for requirements that do not apply to your device and print out or create a PDF-document.

Clinical Evaluation Plan checklist

Date:



# Requirement Covered N/A
1 Introduction
2 Identification of the manufacturer
3 Identification of the subject device
3.1 Intended use
3.2 Classification
3.3 Device’s marketing history
3.4 Technical description, product design and characteristics
3.4.1 Identification of applied standards
3.4.2 Applied tests and quality criteria
4 Identification of target groups, indications, contraindications and clinical application
4.1 Intended patient target groups
4.2 User profile
4.3 Indications
4.4 Contraindications / limitations
4.5 Clinical application
4.6 Warnings and precautions
4.7 Clinical performance and degree of innovation
5 Risk analysis and risk management
5.1 General
5.2 Risk analysis and management file
6 Identification of the relevant GSPRs
7 Equivalent devices
7.1 Alternative products
7.2 Equivalent competitor products
7.3 Evidence for equivalence of the devices
8 Clinical data
8.1 Sources of clinical data
8.1.1 Pre-market sources of clinical data
8.1.2 Post-market sources of clinical data
8.2 Strategy and methodology to identify, analyze and appraise all relevant available clinical data
8.3 Appropriate level of clinical evidence in view of the characteristics of the device and its intended purpose
8.4 Strength of evidence provided by data related to subject device, equivalent devices and state-of-the-art
8.5 Methods to be used for examination of qualitative and quantitative aspects of clinical safety
8.6 Clinical investigations
8.6.1 Rationale for waiving clinical investigations (if applicable)
8.7 Evaluation of clinical performance and risks in the context of medical literature
8.7.1 Methodology of literature search
8.7.2 Literature appraisal
8.7.3 Relevance of publications
8.7.3.1 Inclusion Criteria
8.7.3.2 Exclusion Criteria
8.7.3.3 Full-Text Review
8.7.4 Literature search and appraisal protocol
8.7.5 Medical literature review
8.8 Evaluation of clinical performance and risks in the context of market surveillance
8.8.1 Market surveillance by manufacturer
8.8.2 Market surveillance by authorities
9 Benefit-risk analysis
9.1 Acceptability of the benefit-risk ratio for the indications and intended purpose of the device
10 Clinical follow-up
11 Critical analysis
12 CV of the author(s) of the Clinical evaluation plan

Other checklists for MDR/IVDR compliance

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

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Your products

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Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

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Send us an email:
info@mdrc-services.com

Or use the contact form below

 

Solutions

EU Authorised Representative (EC REP)

EU PRRC

Technical documentation

Risk management

Clinical evaluation

Notified Bodies

Quality management system

Post-market surveillance

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

MDR-compliant quality system documentation checklist for medical device software

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

PRRC under MDR or IVDR

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

Devices

General medical devices and equipment

In vitro diagnostics (IVD)

Medical software

Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.