EU IVDR Compliance: Everything IVD Manufacturers Must Know

The EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) isn’t just an upgrade from the IVDD—it’s a complete overhaul. Enforced since May 26, 2022, the IVDR imposes strict rules on the classification, conformity assessment, and performance evaluation of IVDs in the EU market.

If you manufacture, import, distribute, or place IVD devices in Europe, this regulation applies to you.

What Is the EU IVDR?

The IVDR is a legally binding regulation that governs in vitro diagnostic medical devices—products used to examine specimens derived from the human body (e.g., blood, saliva, tissue) to provide information on health status, diseases, or predispositions.

It replaces the In Vitro Diagnostic Directive (IVDD 98/79/EC) and brings IVDs under a centralized, high-standard regulatory framework. Unlike a directive, the IVDR applies directly across all EU member states, leaving no room for national variation.

Scope and Classification: A Risk-Based Approach

Under the IVDR, devices are classified into four risk classes:

• Class A (low risk – e.g., lab instruments)
• Class B
• Class C
• Class D (high risk – e.g., HIV, Hepatitis, blood grouping)

Most devices under IVDD were self-certified. Under IVDR, approximately 80–90% now require Notified Body involvement.

Classification is based on risk to individuals and public health, not just device function.

Performance Evaluation Requirements

The IVDR mandates robust performance evaluation for all IVDs. This includes:

1. Scientific Validity – evidence linking the analyte to the clinical condition.
2. Analytical Performance – accuracy, precision, sensitivity, specificity.
3. Clinical Performance – ability to yield clinically meaningful results.

Manufacturers must document this in a Performance Evaluation Report (PER), updated throughout the device lifecycle.

##CE Marking and Conformity Assessment

Conformity assessment under IVDR depends on the classification:

• Class A (non-sterile): Self-certification
• Class A (sterile), B, C, D: Require a Notified Body audit

Once compliant, the manufacturer may affix the CE mark, but the requirements to get there are now much stricter.

Documentation: The Technical File and GSPRs

Manufacturers must build a technical documentation file showing conformity with the General Safety and Performance Requirements (GSPRs) in Annex I of the IVDR.

Key inclusions:

• Device description and specifications
• Risk management strategy
• Performance evaluation plan
• Labeling and instructions for use
• UDI assignment and traceability plan

Post-Market Surveillance (PMS) & Vigilance

IVDR requires a proactive PMS system, not a reactive one.

• Class B–D devices must maintain a Periodic Safety Update Report (PSUR)
• Vigilance reporting timelines are accelerated (15 days for serious incidents)

Manufacturers must continuously collect and analyze post-market data to update the benefit-risk profile of the device.

Economic Operators and Their Roles

Like MDR, IVDR defines four economic operators:

1. Manufacturer
2. Authorized Representative
3. Importer
4. Distributor

Each has distinct responsibilities, including:

• Ensuring documentation availability
• Reporting complaints or non-conformities
• Verifying CE marking and labeling language

Manufacturers outside the EU must appoint an Authorized Representative within the EU.

EUDAMED and UDI

The IVDR mandates the registration of:

• Devices
• Economic operators
• Clinical performance studies

…in EUDAMED, the EU’s central regulatory database.

In addition, every IVD must be assigned a UDI (Unique Device Identifier) to ensure traceability throughout its lifecycle.

IVDR Transition Deadlines (As of 2025)

Due to capacity issues among Notified Bodies and industry readiness, the EU has extended IVDR transition periods:

• Class D: Until May 26, 2025
• Class C: Until May 26, 2026
• Class B and Class A (sterile): Until May 26, 2027

Only applies to legacy devices with valid IVDD certificates and no significant changes.

How Acquis Helps You Meet IVDR Compliance

Acquis automates and streamlines IVD regulatory compliance with features like:

• Digital GSPR alignment tools
• Supplier collaboration for substance disclosure
• Performance evaluation traceability
• UDI and EUDAMED registration support
• PSUR and vigilance reporting automation
• Compliance workflows for economic operators

Whether you're Class A or Class D, Acquis helps you reduce compliance risk and accelerate CE marking under the IVDR framework.

Request a demo to align your team with EU IVDR today.