EU IVDR Technical File Checklist

Purpose: This checklist serves as a comprehensive guide for manufacturers to ensure that their medical devices comply with the European Union's In Vitro Diagnostic Regulation (EU IVDR - 2017/746). It outlines the necessary steps and documentation
required throughout the device's lifecycle, from initial planning and design to manufacturing, testing, and post-market surveillance. By following this checklist, manufacturers can demonstrate conformity with EU regulations, ensuring the safety, quality, and
efficacy of their medical devices.

Reference-
Applicable/Not Applicable ( Include justification in case
EU IVDR Specifications Company's Detail Reference Documents
of Non-Applicability)
2017/746

<Provide reference of the document

where this is covered and mention
<Mention if the section is applicable or not. Incase if the
the section of the document>
Company's Name Name of the company section is not applicable provide the justification on why it is not
applicable>
eg: Technical File_XYZ
General
Product_Section 5.2.1
Details
Company's Address Official Address - -
Company's Website URL of website - -
E-mail Official mail ID - -
Contact Number Official Number - -
Product Name Commercial name/ generic name - -

Explain the use for which the device is intended such as intended population, intended user, function of the
Intended Pupose of the
device, whether it is automated or not, if it detects any specific disorder, what is to be detected, details of the - -
Product
specimen if required, and whether it is for qualitative, semi-quantitative or quantitative analysis.

Instruction for Use and How to use this device, when and why device should be used, technical specifications, maintainance
- -
Labelling requirements, troubleshooting infomation, risk-related information, copies of labeling and packaging.

UDI Number Include a UDI or product code. - -

Risk Class & Justification The organization should specify the product class and provide a rationale for this classification. - -

Principle of Operation of the

Document explaining how the entire system can be operated correctly. - -
Device

Justification of Product Being Define intended use and indications for use correctly, Global Unique Device Identification Database can also
- -
Considered as Medical Device be used.
Device
Description Explanation of Novel Feature,
Address unique features that were previously unavailable, if any. - -
and if any.
Specifications
Specimen Collection and The description of the specimen collection and transport materials provided with the device or description
- -
Transport Material of specifications recommended for use.
Specifications
Description
and
Specifications

<Mention if the section is applicable or not. Incase if the

section is not applicable provide the justification on why it is not
applicable>
Software Description A description of any software to be used with the device. -
eg: This section is not applicable as the product does not
include software
Language in which IFU is
Mention language in which IFU is written. - -
Written

An overview of the previous versions or current version of the device produced by the manufacturer (if
Version - -
applicable).
A summary of similar devices identified in the Union or international markets, where such devices are
Predicate Device Information - -
available.

Description of Accessories for

Document explaining additional medical device accessories to be used. - -
a Device, if any.

Product Planning Report Document includes market research, customer focus and requirements. - -

Customer Requirement Report The specifications or features of a product or service that are deemed necessary by customers. - -

Design information includes details about the design process, components, specifications, and requirements
Design Information - -
of the device.

A description of the critical ingredients of the device such as antibodies, antigens, enzymes and nucleic acid
Critical Device Ingredients - -
primers provided or recommended for use with the device.
Description
Information of Personnel Who
Reviewed and Approved Define responsibility and authority, mention name and designation of the personnel who reviewed and
- -
Product During Development approved product during development phases.
Phases
Design Change Evidence, if Include relevant evidence, if there is any kind of Modifications made during development phases or after
- -
any. development.

Verification Evidence Demonstrate design outputs meet the design inputs. - -

The document explaining how the final device meets the user requirements such as assay cut-off,
Validation Evidence measuring range of assay,biocompatibility, usability engineering, cybersecurity, code, architectural review, - -
and specimen testing evidences.

Comprehensive System Provide system Overview for Instruments and Software. - -

Overview

Design and Design Features - -

Include design characteristics for self-testing or near-patient testing devices.
Manufacturing
Information
Data Interpretation - -
Algorithm description for data interpretation methodology.
Methodology

Stability and Shelf Life Provide evidence relevant to in-use stability, shipping stability and claimed shelf life. - -

In the case of devices placed on the market in a sterile or defined microbiological condition, a description of
Sterlization - -
the environmental conditions for the relevant manufacturing steps.
It should include information on the device's analytical sensitivity, specificity, accuracy, precision, and
Analytical Data - -
analytical accuracy, provide evidence relevant to a comprehensive understanding of its performance.
Document includes planning, user requirements, design inputs and outputs, risk analysis,usibility testing,
Design History File - -
verification and validation, design approval, design transfer.
 Include the documents relevant to manufacturing processes for production, assembly, final product testing,
Manufacturing Process - -
and packaging.
Information

Manufacturing Site
Identification of all sites, including suppliers and sub-contractors, involved in manufacturing activities. - -
Identification

How the product is created and maintained, specifications, drawings, assembly procedures, inspection
Device Master Record - -
sheets, test protocols, service procedures.

Device History Record It includes production records, inspection, testing result, device labelling and packaging record - -

Traceability Information Information on how device can be traced throughout the entire lifecycle, including batch and serial numbers. - -

Define list of material and amount is used, packaging material used, detail of steps completeded in
Batch Manufacturing Record manufacturing process and time of completion, personnel responsible for every step,quality control - -
information, quality product and deformities,if any.
Evidence of Conformance Audit reports, certifications, policies, training records, monitoring logs, testing results etc. - -
Clinical Data Clinical evaluation reports, information of any clinical investigation conducted. - -
Non-Conformance, if any. Mention and justify if there is any failure to conform to standard norms. - -

Justification on Regular
Define Management review practices. - -
Review of Safety Requirement
General
Safety and Packaging Information relevant to packaging methods used for the device shall be included. - -
performance Applied Standard Mention standards applied such as ISO 123485:2016. - -
Requirement Evidence of Amendments, if
Justification and evidence of any changes if made after validation. - -
any.
Integrated Device
Configuration and
If the device is to be connected to other equipment to operate as intended, a description of the resulting - -
Conformance to Safety and
combination including proof that it conforms to the general safety and performance requirements.
Performance Requirements

The risk management plan outlines strategies for identifying, analyzing, and responding to potential risks to
Risk Plan - -
ensure the safety and performance of the device.

The risk file includes documentation related to the identification, assessment, and management of risks
Risk File - -
throughout the product lifecycle.
Risk Analysis
A risk report includes identified risks, potential impact, and mitigation strategies, providing stakeholders with a
Risk Repot clear understanding of the product's risk landscape and the actions being taken to manage them effectively. - -

A human factors study should include an analysis of how users interact with the device, considering aspects
Human Factor Study - -
like user interface design, usability, and ergonomics to optimize user experience and safety.
How post-market data will be collected, analysed, what actions will be taken in case of safety and
Post Market Surveillence Plan - -
Post Market performance concerns and the frequency of planned revision.
Surveillence Post Market Surveillence Description of any corrective and preventive action taken, main findings and analyses of PMS activities,
- -
Report sales volume of the device.