IVDR Certification: Complete Guide for IVD Manufacturers (2026)

What Is IVDR?

EU Regulation 2017/746 (IVDR) is the European regulation governing in vitro diagnostic medical devices — products used to examine samples taken from the human body, such as blood, urine, or tissue, in order to provide information about physiological or pathological states.

IVDR replaced the former IVD Directive (98/79/EC, IVDD) and introduced significantly more demanding requirements, particularly around performance evaluation, clinical evidence, and Notified Body involvement. The regulation became fully applicable on 26 May 2022, with transitional arrangements for legacy devices.

IVDR Device Classification

IVDR introduces a four-class risk-based classification system (A, B, C, D), replacing the IVDD's simpler list-based approach:

Classification rules are set out in IVDR Annex VIII. Unlike MDR for medical devices, IVDR classification is based on intended purpose and risk — not just the physical characteristics of the device.

Notified Body Requirements Under IVDR

The requirement for Notified Body involvement under IVDR is dramatically broader than under the IVDD:

• Class A (non-sterile, no measuring function): Self-declaration — no NB required
• Class A (sterile or with measuring function): NB involvement for the sterile or measuring function aspect only
• Class B: NB assessment of technical documentation (at least one representative device per category)
• Class C: Full NB assessment including quality system audit
• Class D: Full NB assessment plus batch release testing at an EU reference laboratory

This represents a massive change from IVDD, where only devices on the IVDD Annex II list required NB involvement. Under IVDR, all Class B, C, and D devices — which represent the majority of IVDs — require an NB.

Performance Evaluation Under IVDR

One of the most significant changes under IVDR is the requirement for performance evaluation — the equivalent of clinical evaluation under MDR. Manufacturers must demonstrate that their IVD devices achieve the intended purpose based on clinical and/or scientific evidence.

IVDR Annex XIII defines the performance evaluation requirements. Performance evaluation encompasses:

• Analytical performance — accuracy, precision, sensitivity, specificity, linearity, measuring range, interference, cross-reactivity
• Clinical performance — diagnostic sensitivity, diagnostic specificity, positive and negative predictive values (where applicable)
• Scientific validity — the association between the analyte and the clinical condition or physiological state

For Class C and D devices, the performance evaluation report must be particularly robust, based on clinical performance studies and/or peer-reviewed published data.

EU Reference Laboratories for Class D Devices

Class D devices face an additional requirement unique to IVDR: EU Reference Laboratories (EURLs). These are designated laboratories that verify the performance claims of Class D devices and conduct batch release testing.

The Notified Body must obtain an opinion from the relevant EURL before issuing a certificate for a Class D device. This process adds significant time to the Class D certification pathway — plan for 6–12 months additional to the standard NB timeline.

Common Specifications for IVDs

The European Commission has the authority to publish Common Specifications (CS) for IVDR devices — similar to those for MDR Annex XVI products. Common Specifications define minimum performance, safety, and performance evaluation requirements for specific device types.

For devices covered by a CS, compliance with the CS is mandatory. Manufacturers must check whether a CS exists for their device type and incorporate its requirements into their technical documentation.

IVDR Transition Timeline

These transition deadlines apply to devices already on the market under IVDD. New devices not previously placed on the market must comply with IVDR from the moment of first placement. Verify your specific situation with a regulatory consultant — the transitional provisions are complex and subject to updated guidance.

IVDR Technical Documentation Requirements

Similar to MDR, IVDR requires comprehensive technical documentation covering:

• Device description, intended purpose, and classification justification
• Design and manufacturing information
• General Safety and Performance Requirements checklist
• Benefit-risk analysis and risk management (per ISO 14971)
• Performance evaluation report (analytical and clinical performance)
• Post-market performance follow-up (PMPF) plan
• Labelling and instructions for use
• EUDAMED registration documentation

EU Authorised Representative for Non-EU IVD Manufacturers

Non-EU manufacturers of IVDs must appoint an EU Authorised Representative under IVDR Article 11 — in exactly the same way as MDR device manufacturers. The AR must be established in the EU, is named on the label, and is registered in EUDAMED.

→ See full guide: EU Authorized Representative Under MDR | EAR Services Guide

Frequently Asked Questions