The IVDR is the regulation that caught the diagnostics industry off guard. Under the old IVD Directive roughly 80% of in vitro diagnostics were self-certified. Under Regulation (EU) 2017/746 that figure inverted — the large majority now need a notified body.
This guide sets out what IVDR requires, where the extended deadlines actually land, and what an IVD manufacturer outside the EU has to put in place.
What changed from the IVD Directive
Directive 98/79/EC classified IVDs by list membership. IVDR replaced that with a risk-based, rule-driven classification in Annex VIII, running from Class A (lowest risk) to Class D (highest).
The consequences:
- Notified body involvement became the norm. Everything above Class A non-sterile requires one.
- Performance evaluation became a formal structure. Annex XIII requires scientific validity, analytical performance and clinical performance, documented as a Performance Evaluation Report and kept current.
- Class D devices face additional layers — EU reference laboratory testing, batch verification and common specifications where they exist.
- In-house devices came into scope. Article 5(5) brings laboratory-developed tests under defined conditions.
Classification under Annex VIII
| Class | Risk | Examples | Notified body |
|---|---|---|---|
| A | Low individual, low public health | Specimen receptacles, buffers, general lab instruments | Only if sterile |
| B | Moderate individual, low public health | Pregnancy tests, cholesterol, most self-tests | Yes |
| C | High individual, moderate public health | Cancer markers, companion diagnostics, infectious disease staging | Yes |
| D | High individual and public health | HIV, hepatitis, blood grouping, transmissible agent screening | Yes, plus EU reference laboratory |
Where the deadlines actually stand
Regulation (EU) 2024/1860 extended the transition for legacy devices — those with a certificate or declaration of conformity under Directive 98/79/EC issued before 26 May 2022.
| Class | May be placed on market until | Notified body application deadline |
|---|---|---|
| Class D | 31 December 2027 | 26 May 2025 |
| Class C | 31 December 2028 | 26 May 2026 |
| Class B | 31 December 2029 | 26 May 2027 |
| Class A sterile | 31 December 2029 | 26 May 2027 |
After each application deadline, a written contract with the notified body must be concluded within four months. Miss that and the extension is lost.
Two categories get nothing: Class A non-sterile devices, and entirely new IVDs that were not on the market before 26 May 2022. Both have had to comply with IVDR in full since 26 May 2022.
The conditions attached to the extension
- The device was legally on the market before 26 May 2022 under Directive 98/79/EC
- It continues to comply with the rules in force when first placed on the market
- No significant change in design or intended purpose
- It presents no unacceptable risk to health or safety
- A QMS compliant with IVDR was in place by 26 May 2025
- The notified body application and written contract deadlines above were met
If your Class C devices are still trading on the extension, the 26 May 2026 application deadline has passed. Confirming whether you met it is not optional housekeeping.
EUDAMED applies to IVDs too
The same four modules that became mandatory on 28 May 2026 apply to in vitro diagnostics: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance.
Devices already on the market before that date must be registered in the UDI module by 27 November 2026. For IVD manufacturers with broad assay portfolios this is a substantial data exercise, because every device and every configuration needs its own UDI-DI. It is not a task to begin in November.
Performance evaluation: the heart of an IVDR file
Annex XIII requires three linked components, and a weakness in any one undermines the whole argument:
- Scientific validity — the association between the analyte and the clinical condition. Usually established from literature, consensus or existing clinical evidence.
- Analytical performance — sensitivity, specificity, trueness, precision, accuracy, limit of detection, linearity, interference, cross-reactivity, specimen stability.
- Clinical performance — diagnostic sensitivity and specificity, predictive values, likelihood ratios, in the intended population and intended use setting.
These are documented in a Performance Evaluation Plan, delivered as a Performance Evaluation Report, and kept current through Post-Market Performance Follow-up (PMPF).
The most common finding we see is clinical performance data drawn from a population that does not match the stated intended purpose — a test validated on a hospital cohort but labelled for primary care screening, for instance.
What a non-EU IVD manufacturer must have
- EU Authorised Representative under Article 11, with a written mandate. As under MDR, the AR carries joint liability for defective devices.
- Person Responsible for Regulatory Compliance under Article 15, with the defined qualifications.
- UDI system — Basic UDI-DI and UDI-DI per device, through a recognised issuing entity.
- QMS to ISO 13485:2016, mapped to IVDR Article 10(8).
Additional requirements for Class D
Class D devices carry obligations no other class does:
- EU reference laboratory verification of performance against common specifications, where an EURL has been designated for that device type
- Batch verification by the notified body or EURL
- Common specifications compliance where they exist, or justification of an equivalent or higher safety level
- Summary of Safety and Performance (SSP), published in EUDAMED
These add real time. A Class D programme planned on a Class C timeline will not hold.
Why IVDR projects overrun
- Classification decided optimistically. Rule 3 catches far more devices in Class C than manufacturers expect. Get classification wrong and the entire conformity route is wrong.
- Legacy performance data that does not meet Annex XIII. Data generated under the Directive frequently lacks the structure IVDR requires.
- Notified body capacity. There are far fewer IVDR-designated notified bodies than MDR ones, and they are selective.
- Intended purpose drafted too broadly. Every claim in the intended purpose must be supported by performance data.
- EUDAMED treated as an afterthought.
How Medfins International supports IVDR compliance
We support IVD manufacturers with Annex VIII classification and rule interpretation, IVDR gap assessment, performance evaluation planning and PER preparation, technical documentation to Annexes II and III, QMS alignment to Article 10(8), notified body selection and application management, EU Authorised Representative arrangements, EUDAMED actor and UDI registration, and post-market performance follow-up.
Frequently asked questions
What are the IVDR transition deadlines?
Under Regulation (EU) 2024/1860, legacy Class D devices may be placed on the market until 31 December 2027, Class C until 31 December 2028, and Class B and Class A sterile until 31 December 2029. Class A non-sterile devices and new IVDs received no extension and have been subject to IVDR in full since 26 May 2022.
Does my IVD need a notified body under IVDR?
Almost certainly, unless it is Class A non-sterile. Class A sterile, and all Class B, C and D devices require notified body involvement. This is the single biggest change from the IVD Directive, under which most IVDs were self-certified.
What is the difference between MDR and IVDR?
MDR (2017/745) governs medical devices; IVDR (2017/746) governs in vitro diagnostics — tests performed on samples taken from the body. They share structure, EUDAMED, UDI and the Authorised Representative concept, but IVDR uses a different Class A to D classification and replaces clinical evaluation with performance evaluation under Annex XIII.
What is a Performance Evaluation Report?
The PER documents scientific validity, analytical performance and clinical performance for your device, following a Performance Evaluation Plan under Annex XIII. It must be maintained throughout the device lifecycle and updated with post-market performance follow-up data.
Do in-house tests fall under IVDR?
Yes. Article 5(5) brings devices manufactured and used within a single health institution into scope under defined conditions, including that no equivalent CE-marked device is available on the market and that the institution operates an appropriate quality management system.
Unsure where your IVD portfolio stands?
If you need classification confirmed, performance evidence assessed against Annex XIII, or EUDAMED registration completed before 27 November 2026, we can review your position and give you a clear answer.
Write to sales@medfinsinternational.com or call +91 8527048221.