EU IVDR: more devices need a notified body, and more evidence
Under IVDR most diagnostics need a notified body for the first time. Production records have to keep up with the new evidence.
In Short
- Four classes, A to D; most beyond non-sterile A need a notified body.
- Legacy-device transition depends on conditions; check Article 110.
- People decide what is a reportable serious incident.
The Medical Device Production Guide
Built to revision. Inspected. On record.
- What the QMSR changed in February 2026
- Supplier to finished build
- Inspect, review, correct
- Labels, UDI and traceability
Plus Evidence map and four worksheets.
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The Medical Device Production Guide
Built to revision. Inspected. On record.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has applied in the EU since 26 May 2022. It replaced a directive under which most IVDs were self-declared. It has since been amended, including by Regulation (EU) 2024/1860, which extended transitional provisions for certain legacy devices under conditions. This guide covers what IVD manufacturers ask about most. Checked against the European Commission's medical devices pages on 2 Oct 2026; the EUR-Lex text could not be opened from our tools, so exact transition dates are not stated here.
Risk Classes
IVDR uses four classes, A to D, set by classification rules in Annex VIII. Class D covers the highest public-health risk, such as tests for transmissible agents in blood for transfusion.
IVDR Classes at a Glance
Pick a class.
- Self-declared if non-sterile. Sterile class A needs a notified body for sterility aspects.
More on risk Classes
Most devices beyond class A (non-sterile) need a notified body, which is the biggest change from the old directive.
Transition for Legacy Devices
Devices certified or declared under the old directive may stay on the market for limited periods if conditions are met, including a compliant quality management system and an application to a notified body. Amending Regulation 2024/1860 extended these periods by class.
More on transition for Legacy Devices
Check the consolidated text of Article 110 and your notified body for the dates that apply to your devices.
Performance Evaluation
Every IVD needs a performance evaluation covering scientific validity, analytical performance and clinical performance, kept up to date across the device's life. For class C and D devices a summary of safety and performance is published.
The Quality Management System
Article 10 requires a quality management system covering, among other things, production, supplier control, risk management, post-market surveillance and corrective action. Many manufacturers base it on ISO 13485.
Production Evidence a Notified Body May Sample
More on the Quality Management System
Production records should show which lots of reagents and components went into each finished lot.
Post-Market and Vigilance
Manufacturers run post-market surveillance, report serious incidents and field safety corrective actions, and keep technical documentation current. People decide whether an incident is reportable and record why.
Questions
When did IVDR start to apply?
26 May 2022. Transitional provisions, extended by Regulation (EU) 2024/1860, let certain legacy devices stay on the market for limited periods under conditions.
Do class A devices need a notified body?
Non-sterile class A devices are self-declared. Sterile class A devices need notified body involvement for the sterility aspects. Classes B, C and D need a notified body.
Is ISO 13485 required under IVDR?
IVDR requires a quality management system under Article 10. ISO 13485 is the standard most manufacturers use to meet it, and notified bodies audit against it, but the regulation sets the requirement.
Does V5 handle IVDR submissions?
No. V5 keeps production and device history records, lot trace, documents, complaints and CAPA. Your regulatory team prepares technical documentation and decides what is reported.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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