Custom file system for IVDR
Appfront builds dossier systems for manufacturers of in vitro diagnostic medical devices that fall under the European IVDR regulation. For each device: the technical documentation, the general safety and performance requirements with the evidence behind them, the performance evaluation with plan and report, risk management, and post-market data. With versioning, an overview of what is still missing, and a dossier that is ready when the notified body asks questions.
What is an IVDR dossier system?
Since the European in vitro diagnostic regulation, IVDR, applies, far stricter documentation requirements have come into force for tests, reagents, analysers and diagnostic software. Devices are classified from Class A to Class D. Each device needs technical documentation, including the general safety and performance requirements, a performance evaluation with plan and report, risk management and post-market surveillance data. For most classes, a notified body reviews that documentation.
In practice, that documentation sits in folders of documents, linked through a spreadsheet that shows which document covers which requirement. A document gets a new version, but the spreadsheet still points to the old one. A requirement has no evidence, and that only comes to light when the notified body asks for it. Post-market surveillance data has to feed back into the performance evaluation, but it lives in a different system.
We build custom solutions because manufacturers differ: which devices and classes they have, how their quality management system is set up, which documents already exist, and which notified body they work with. What the regulation requires for your devices is determined by you with your regulatory adviser and the notified body; the system records what is needed and shows where it is missing.
Complete per device
Technical documentation for each device, with class, intended purpose and all the components the regulation requires.
Requirements with evidence
Every general safety and performance requirement linked to its evidence and the standards applied, with versions.
Ready for assessment
An overview of what is missing, and access for the notified body or adviser to what they need to see.
How we build your IVDR dossier system
We start with one device: which class, what documentation already exists, how it is currently organised, and where the gaps are.
Your devices, classes, existing documents, quality management system and notified body.
The structure of the technical documentation, and the requirements linked to evidence.
The performance evaluation plan and report, and post-market data.
An overview of open actions, access for assessors, and management when new versions arrive.
What an IVDR dossier system actually does
The components below come up for almost every manufacturer of in vitro diagnostics. Which ones you need depends on your devices.
Devices
Devices with class and intended purpose.
Technical documentation
The components the regulation requires, for each device.
Requirements and evidence
Safety and performance requirements linked to evidence and standards.
Performance
Performance evaluation plan and report, with the underlying data.
Risk management
Risks and controls for each device.
Versions and approval
Document versions with approval and history.
Who we build an IVDR dossier system for
The system is designed for anyone who drafts, manages or reviews IVDR documentation.
Test manufacturers
Reagents and tests across several classes. Requirements with evidence are at the core.
Software manufacturers
Diagnostic software. The performance evaluation matters most.
Laboratories
In-house tests within an institution. The overview of what is needed is exactly what you need.
Regulatory advisers
Supporting multiple manufacturers. The dossier per client is at the core.
Test your idea first: a working prototype in 1 day
With OneDayBuild, we turn your idea into something tangible in one day for €1,150, so you can see whether further development is worth the investment. Decide to go ahead with the full build? Then we credit the full cost.
Explore OneDayBuild →Technology and integrations
This page is about documentation for IVDR. For medical devices under the MDR, see our page on an MDR technical file and PMS system, for laboratories our page on laboratory software, and for quality systems our page on a custom quality management system. You can read about our approach at custom software development.
Why choose Appfront for your IVDR technical file system?
A requirement without evidence will be spotted by the notified body, and fixing it takes time you may not have. That is where we focus: documentation per device, requirements linked to evidence, and an overview of what is missing.
Gaps spotted early
Anything missing is visible before the assessment.
Versions in order
Every requirement always points to the current version of its evidence.
Fewer questions
The assessor finds what they need.
Security and privacy in an IVDR technical file system
The system holds confidential information about your devices, such as design, performance and risks. Access is set up by role and by device, assessors see only what is intended for them, and every change is logged.
The system runs in a European data centre or in your own environment, with encrypted storage, daily backups and sign-in with a second factor.
Frequently asked questions about an IVDR technical file system
Questions manufacturers and consultants ask before getting started.
It organises the technical documentation for each device, links every general safety and performance requirement to its evidence, manages the performance evaluation and risk management, keeps track of versions, and shows what is still missing. A reviewer sees only what is intended for that review.
The European regulation for in vitro diagnostic medical devices, Regulation (EU) 2017/746. It applies to tests, reagents, analysers and diagnostic software, classifies devices into classes A to D, and sets requirements for technical documentation and performance evaluation.
The MDR applies to other medical devices and requires a clinical evaluation. The IVDR requires a performance evaluation, with its own requirements for scientific validity and analytical and clinical performance. There is a separate page for the MDR.
That depends on the class and type of device. The regulation describes what the technical documentation must contain. You determine what applies to your devices with your regulatory consultant and the notified body; the system follows the structure you define.
Yes. Existing documents are placed into the structure and linked to the requirements. That makes it immediately clear which requirements already have evidence and which do not.
Yes, if that system offers an interface. Documents and versions can come from the quality management system, so they are not maintained twice.
Check this first. A quality management system manages documents and versions, and that is a large part of the work. Custom development makes sense when the linking of requirements to evidence, the performance evaluation and the overview of gaps are missing.
Technical documentation ready for assessment?
Tell us which devices and classes you have, how your documentation is currently organised, and which notified body you work with. We will show you what the file, the requirements and the overview look like.