The technical file for In-Vitro Diagnostic (IVD) medical devices refers to all the documents that an IVD manufacturer must prepare and submit to demonstrate that the product conforms to the applicable and current In-Vitro Diagnostic medical device regulations. This documentation serves as evidence that the device meets essential safety and performance requirements under the In-Vitro Diagnostic Regulation (IVDR).
The IVDR technical documentation for such devices includes, for instance, a detailed description of the device and its specifications, references to previous and similar generations of the device, design and development information, pre-clinical testing data, performance evaluation results, and risk management processes associated with the medical device. Each of these components is critical for assessing the overall compliance of the device with the regulatory framework.
The IVD technical file must also be meticulously organized. The information included should be clear, readily searchable, and presented in a logical, unambiguous manner. This ensures that regulatory authorities and notified bodies can easily evaluate the device’s safety and performance. The tech file medical device submission should comprehensively demonstrate the device’s ability to perform as intended, without posing any risks to patients or users.
Manufacturers can benefit from using an IVD technical file template to streamline the preparation process, ensuring that all necessary details are included and structured correctly. Additionally, an IVDR technical documentation template can help maintain consistency and compliance with regulatory requirements, reducing the risk of errors or omissions.
Proper preparation and maintenance of the IVDR technical documentation are vital for successful market access and the long-term compliance of In-Vitro Diagnostic medical devices.
In-Vitro Diagnostic Medical Device (IVDR) Technical Documentation preparation
Want to prepare an IVDR Technical Documentation as per the requirements of MDR 2017/746? If your answer is yes, you likely have many questions about preparing medical device technical files, such as:
What should be covered in the IVDR Technical Documentation?
Which Annex of EU 746/2017 should be referred to for preparing the documentation?
Who will review and approve the IVDR Technical Documentation?
At Maven Profcon Services LLP, we provide all the answers to these questions and guide you through the preparation process.
The In-Vitro Diagnostic Medical Device (IVDR) Technical Documentation must comply with the requirements of Annex II and Annex III of IVDR 2017/746. This documentation serves as evidence that the medical device meets the applicable safety and performance requirements under the regulation.
The completed tech file medical device should be submitted to the notified body or competent authority for review and approval as part of the CE certification process. It must be prepared in the English language or an official language of an EU member state.
Manufacturers, authorized representatives, and importers of in vitro diagnostic devices must retain the IVDR Technical File, declarations of conformity, and copies of all relevant certificates for a period of 10 years after the last device is placed on the market.
Economic operators of in vitro diagnostic devices are also required to maintain supply chain records during the 10-year retention period, as stipulated in Article (10)(7) of MDR 2017/746.
The EU IVDR explicitly requires manufacturers (or their authorized representatives) to retain several key documents for 10 years after the last device is placed on the market, including:
The EU declaration of conformity;
Quality management system documentation;
Documentation of procedures for monitoring, verifying, validating, and controlling the design;
The IVD Technical File Template and technical documentation;
Copies of EU type-examination certificates; and
Similar supporting documents.
Moreover, Annex XIV-Chap II.3 requires sponsors of clinical trials for IVD medical devices to maintain records such as application forms, investigators’ brochures, performance study plans, and other similar documents for at least 10 years after the conclusion of the clinical performance study. If the device is marketed, the retention period extends to 10 years after the last device is placed on the market.
If you are searching for an IVD Technical File or need a comprehensive IVDR Technical Documentation Template, our team can assist you in developing a compliant tech file medical device to meet EU MDR 2017/746 standards.
Technical File content
Sr. No.
Section
Description
Section 1 General and Administrative Information
1.
1.0
Table of Content
2.
1.1
Technical file approval team
3.
1.2
General information for the Technical file structure including purpose, scope
4.
1.3
Company Profile
5.
1.3.1
Legal Name & Address of the Manufacture
6.
1.4
Authorized Representative name, address and contact details
7.
1.5
Notified Body Name, Number and Address
Section 2 Technical Documentation
8.
2.1
Device Description And Specification, Including Variants And Accessories
9.
2.1.1
Device description and specification
Product name or trade name
General Description of Device
Intended Purpose
Indication of use
10.
2.1.1.1
11.
12.
13.
14.
2.1.1.2
Basic UDI-DI
15.
2.1.1.3
Intended patient populations, including details of if applicable;
Medical Condition to be diagnostic, treatment, or monitoring
Patient selection criteria
Indication
Contraindications
Warning
16.
2.1.1.4
Principle of operation including mode of action
17.
2.1.1.5
Rational for considering the product as medical device
18.
2.1.1.6
Device Classification and Justification for the classification rule as per Annex VIII
19.
2.1.1.7
Explanation of Novel Features
20.
2.1.1.8
Description of Accessories of device
21.
2.1.1.9
A Description of various configurations/variants
22.
2.1.1.10
General description of key components for including software where appropriate required add photograph, drawing and Diagram
23.
2.1.1.11
Description of Raw Materials
24.
2.1.1.12
Technical Specification like feature, dimension
25.
2.2
Reference of Previous and Similar Generations of the device
26.
2.3
Information Supplied by the Manufacturer
27.
2.3.1
Labels: Primary Label, Secondary label and Tertiary label
If you are selling device require specific county language then label should be available on that language
28.
2.3.2
Instruction for use (IFU)
If you are selling device require specific county language then IFU should be available on that language
29.
2.4
Design and Manufacturing Information
30.
2.4.1
Product design File
31.
2.4.2
Manufacturing process and their process validations
32.
2.4.3
Final Product Specification & Testing
33.
2.4.4
Manufacturing Environment Control
34.
2.4.5
Identifying the sites including supplier & subcontractors, where design activities are performed
35.
2.5
Safety & Performance Requirements
36.
2.5.1
List of Applicable Harmonized Standards, Common Specification (CS), Non-harmonized standards, applicable guidelines
37.
2.5.2
General Safety & Performance Requirements (GSPR)
38.
2.5.3
Declaration of Conformity
39.
2.6
Benefit and Risk Analysis & Risk Management
40.
2.7
Product Verification and Validation
41.
2.8
Performance testing
42.
2.8.1
Analytical performance testing
43.
2.8.2
Clinical Performance testing
44.
2.8.3
Electrical Safety and compatibility
45.
2.8.4
Physical, Chemical & Microbiological Compatibility
46.
2.8.5
Software Verification and Validation
47.
2.8.6
Stability or self-life
48.
2.8.7
Sterilization
49.
2.8.8
Performance Evaluation Plan & Report
50.
2.8.9
Summary of Safety & Performance
51.
2.8.10
Post Marketing Activities
PMPF Plan & Report
PSUR Report
PMS Plan & Report
Trend Reports
52.
2.8.11
Packaging & Transportation information
53.
2.9
Additional Information is required in specific case:
54.
2.9.1
When device incorporate a substance consider separately as medicine
55.
2.9.2
Device is manufactured by using tissue or cells of human or animal origin
56.
2.9.3
Device that are composed of substance or combination of substance
57.
2.9.4
CMR or Endocrine-Disrupting Substance
58.
2.10
Detail of Device with measuring function
59.
2.11
Details of the device to be connected to other device to achieved its intended purpose
60.
2.12
Revision History
61.
2.13
Conclusion & Approval
Consultant for Technical Documentation
Our regulatory consultants in Maven who are experienced in various fields of Medical & In-vitro Medical Device Regulations are well versed in taking care of IVDR Technical Documentation like Performance evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering file, safety and biological evaluation, and chemical characteristics evaluation.
Our regulatory consultants help you in identifying requirements as per EU IVDR, identification of CE assessment route according to the class of the device, helps in performance evaluation and also in post-marketing activities, risk analysis, and quality management implementation.
Maven as a developing medical device and In-Vitro Diagnostic medical device regulatory consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The below mentioned activities are taken care by us
Gap analysis of IVDR Technical Documentation as per the requirement of EU-IVDR
Identification and classification of the In-Vitro Diagnostic medical device as per EU IVDR
Help in selection of conformity route of assessment and Notified body
Preparation and review of the tech file medical device documents as per EU IVDR
Support in maintaining and updating the tech file medical device post-certification
