🇪🇺 Live Medical Devices & Diagnostics

EU In Vitro Diagnostic Regulation (Regulation 2017/746)

Regulates the safety, performance, and market placement of in vitro diagnostic medical devices in the EU.

View official source document

Rules extracted

276

Obligations decomposed

19.7x

Avg obligations per rule

🇪🇺 European Union

Jurisdiction

About this regulation

Regulation (EU) 2017/746 establishes the regulatory framework for in vitro diagnostic medical devices in the European Union. It replaces Directive 98/79/EC on in vitro diagnostic medical devices. The IVDR introduces a new risk-based classification system aligned with international best practice, requires conformity assessment by notified bodies for higher-risk devices, strengthens performance evaluation requirements, establishes a comprehensive traceability system through UDI, and mandates post-market surveillance and vigilance obligations. It applies from 26 May 2022 with transitional provisions extending to 2025-2028.

What AuditDSS covers

Source

Regulation

Extracted

Rules

Decomposed

276

Obligations

19.7x

Decomposition ratio

Each rule is decomposed into an average of 19.7 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 276 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in IVDR is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: EU In Vitro Diagnostic Regulation (Regulation 2017/746)
Regulatory body: European Parliament and Council
Jurisdiction: 🇪🇺 European Union
Document type: regulation
Effective date: May 26, 2022
Issuing authority: European Parliament and Council of the European Union
Industry: Medical Devices & Diagnostics
Official source: View source document ↗

Who this applies to

IVD manufacturersauthorised representativesimportersdistributorsnotified bodieshealth institutionslaboratories

Key requirements

general safety and performance requirements
performance evaluation
conformity assessment
risk-based classification (A/B/C/D)
UDI system
EUDAMED registration
post-market surveillance
vigilance reporting
CE marking
companion diagnostic assessment

Frequently asked questions about IVDR

What is IVDR?

Who does IVDR apply to?

IVDR applies to IVD manufacturers, authorised representatives, importers, distributors, notified bodies, health institutions, laboratories.

How many obligations does IVDR contain?

AuditDSS has decomposed IVDR into 276 atomic obligations from 14 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of IVDR?

The key requirements include: general safety and performance requirements, performance evaluation, conformity assessment, risk-based classification (A/B/C/D), UDI system, EUDAMED registration, post-market surveillance, vigilance reporting, CE marking, companion diagnostic assessment.

How can I assess my IVDR compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 276 IVDR obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces IVDR?

IVDR is enforced in European Union by European Parliament and Council.

When did IVDR come into effect?

IVDR became effective on May 26, 2022.

What industry does IVDR apply to?

IVDR is primarily relevant to the Medical Devices & Diagnostics industry. AuditDSS covers 64 regulations in this industry sector.

Build a IVDR compliance pack

Don't have a compliance policy yet? AuditDSS generates a complete compliance pack for IVDR — alone or combined with other regulations your business needs. Every clause is mapped to specific obligations.

Policy

High-level commitments and governance framework covering IVDR requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

Ready-to-use forms, registers, and checklists for day-to-day compliance operations.

Multi-regulation

Combine IVDR with other regulations into a single unified compliance pack for your business.

Build IVDR compliance pack

Already have a policy? Assess it against IVDR

Upload your document

Upload your compliance policy, program manual, or operational document. AuditDSS accepts any text-based document.

AI maps against 276 obligations

Your document is scored against every obligation in IVDR. Each claim is mapped to the obligation tree and evaluated for coverage.

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.