Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices
The IVDR establishes rules for in vitro diagnostic devices, including classification, conformity assessment, quality systems, performance evidence, technical documentation, UDI, registration, vigilance, post-market surveillance, and performance studies.
What the authority record establishes
The IVDR establishes rules for in vitro diagnostic devices, including classification, conformity assessment, quality systems, performance evidence, technical documentation, UDI, registration, vigilance, post-market surveillance, and performance studies.
Directly applicable EU law, subject to its scope and transitional provisions
The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.
Why it matters to this market
IVD quality and regulatory records require device-specific classification, evidence, registration, and post-market workflows. Generic pharma or medical-device templates may not cover performance-study and IVD data needs.
Affected operating stages
- IVD Development And Classification
- Quality-System Operation
- Performance Evaluation
- Conformity Assessment
- Technical Documentation
- Registration And UDI
- Post-Market Surveillance And Vigilance
Capabilities to examine
Controlled Documents
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for controlled documents.
Quality Events And Deviations
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for quality events and deviations.
CAPA
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for CAPA.
Change Control
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for change control.
Audit And Inspection Management
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for audit and inspection management.
Supplier Quality
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for supplier quality.
Complaints And Post-Market Quality
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for complaints and post-market quality.
Quality Risk Management
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for quality risk management.
Design Controls And Product Traceability
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for design controls and product traceability.
Regulatory Product And Registration Data
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for regulatory product and registration data.
Submission Planning And Dossier Management
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for submission planning and dossier management.
Labeling And Structured Product Data
Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for labeling and structured product data.
Affected buyer audiences
- IVD manufacturers
- authorized representatives, importers, and distributors
- quality and regulatory teams
- clinical-performance and laboratory teams
- notified-body stakeholders
Implementation questions
- Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
- What is binding, what is guidance, and what is a technical or consensus standard?
- Which publication, adoption, effective, application, transition, and enforcement dates differ?
- Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
- How will a source revision affect open work and historical decisions?
Interpretation boundary
The applicable transition and conformity path varies by device and status. A platform can support records and deadlines but cannot decide the legal pathway without competent regulatory analysis.