You can use our IVDR Technical Documentation Checklist to evaluate the completeness and alignment of your technical documentation with IVDR requirements.
When pursuing the CE-marking and entering the EU medical device market, a comprehensive grasp of the essential components and proper structure of your technical documentation becomes indispensable.
Fill out the Device field, check the checkboxes for available documents and N/A boxes for documents that do not apply to your device and print out or create a PDF-document.
IVDR technical documentation checklist for in vitro diagnostic medical devices
Date:
Sec.
Requirement / Document
Available
N/A
1
Device description and specification, including variants and accessories
1.1
General description of the device, its variants and its intended purpose
1.1.1
Name and address of the manufacturer
1.1.2
Overview of devices/ device groups/device types
1.1.3
All trade names under which the device is placed on the market
1.1.4
Specification of the device
1.1.5
Technical specifications of the device
1.1.6
Variants/components/configurations and accessories of the device
1.1.7
Exact software version (if applicable)
1.1.8
Explanations of new characteristics and new intended purposes/indications
1.1.9
Sampling and preparation
1.2
UDI
1.3
Qualification as IVD and classification
1.4
Declaration of Conformity (DoC)
1.5
Description of the principles of operation of the device and its mode of action
1.6
Summary of safety and clinical performance (for classes C and D)
1.7
Raw materials, components, packaging materials
1.7.1
Overview of all raw materials, components, packaging materials
1.7.2
Specifications of raw materials components/subassemblies
1.7.3
Specifications of packaging materials (primary and secondary packaging)
1.7.4
Certificates of analysis from the suppliers
1.8
Previous and similar generations
1.8.1
Overview of the previous generation(s) of the device produced by the manufacturer
1.8.2
Overview of the similar generation(s) of the device available on the market in the European Union or on international markets
1.9
European Authorised Representative valid agreement and disply of name and contact information in technicla file and information panels.
2
Labelling / instructions for use
2.1
Labelling
2.2
Instructions for use
3
Design and manufacturing information
3.1
Description of the design
3.1.1
Description of the applied design process
3.1.2
Identification of all sites where design processes were performed
3.2
Description of the manufacturing
3.2.1
Comprehensible description of manufacturing
3.2.2
Addresses of all manufacturing sites with information on the manufacturing steps
3.2.3
Information on specific processes and their validation
3.2.4
Information on controlled conditions under which certain manufacturing steps take place
3.3
Description of quality control
3.4
Outsourced processes, subcontractors
3.4.1
Overview in tabular format of outsourced processes and name/address of the executing companies
3.4.2
Evidence of qualification of subcontractors
3.4.3
Quality assurance agreements with subcontractors for outsourced production steps and in the case of sterile devices for outsourcing of packaging and/or sterilisation
4
General Safety and Performance Requirements
4.1
Systematic evidence of compliance with the General Safety and Performance Requirements
4.2
List of applied standards and common specifications
5
Benefit-risk analysis and risk management
5.1
Risk management plan
5.2
Risk analysis including risk control measures
5.3
Risk management report including the evaluation of residual risks and the evaluation of benefit-risk ratio
5.4
Usablity reports
5.5
Specific Usability Risks (only for Self-Testing / Near-Patient Testing)
6
Product verification and validation
6.1
Device performance
6.1.1
Specimen Type / Handling
6.1.2
Analytical Performance
6.1.3
Analytical Performance Report
6.1.4
Clinical Performance
6.1.5
Performance of self-testing devices / Near-patient testing devices
6.1.6
Scientific Validity
6.1.7
Performance Evaluation Report
6.2
Chemical, Physical and Biological Properties
6.2.1
Nanoparticle Technology
6.2.2
Hazardous Substances
6.2.3
Biological Evaluation
6.2.4
Substances of Animal / Human / Microbiological Origin
6.2.5
Sterile Devices or Devices with Defined Microbiological Condition
6.3
Constructional Safety
6.3.1
Mechanical Safety
6.3.2
Electrical safety / electromagnetic compatibility
6.3.3
Ionising and non-ionising radiation
6.3.4
Environmental protection and safe disposal
6.3.5
Packaging
6.3.6
Devices with connection to other device(s)
6.4
Software verification and validation (if applicable)
6.4.1
Description of the software development process (e.g. according to EN 62304)
6.4.2
Description of the software design (e.g. according to EN 62304, EN 62366)
6.4.3
Validation of the software as used in the finished device: e.g. a. summary results of verifications, validations and tests performed (in-house or in a simulated or in a real user environment)
6.5
Stability, including shelf life
6.5.1
Planning and overview of performed tests
6.5.2
Evidence that the devices meet the defined specifications during the defined shelf life. Results of the individual stability studies and evaluations on the following aspects
6.5.3
Storage stability (accelerated ageing (e.g. Arrhenius equation) and real-time data)
6.5.4
Transport stability
6.5.5
In-use stability
6.5.6
Concept for maintenance and servicing over the entire lifecycle
6.5.7
Evaluation of data and test results
6.6
Measuring function (if applicable)
6.6.1
Planning and overview of performed tests
6.6.2
Test reports of performed tests
6.6.3
Evaluation of data and test results
6.7
Combination with other devices (if applicable)
6.7.1
Planning and overview of performed tests
6.7.2
Test reports of performed tests
6.7.3
Evaluation of data and test results
7
Post-market surveillance
7.1
Post-market surveillance plan (PMS-Plan)
7.2
Periodic safety update report - PSUR (classes C and D)
7.3
Post-market surveillance report (classes A and B)
7.4
Post-market performance follow-up plan (PMPF-Plan)
