Regulation (EU) 2017/745 on Medical Devices
The MDR establishes rules for placing medical devices on the EU market and covers economic operators, conformity assessment, quality systems, clinical evidence, technical documentation, UDI, registration, vigilance, post-market surveillance, and market surveillance.
What the authority record establishes
The MDR establishes rules for placing medical devices on the EU market and covers economic operators, conformity assessment, quality systems, clinical evidence, technical documentation, UDI, registration, vigilance, post-market surveillance, and market surveillance.
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
MDR work crosses QMS, product lifecycle, regulatory registration, UDI, technical documentation, clinical evidence, and post-market systems. Buyers need explicit system boundaries and reliable traceability across them.
Affected operating stages
- Device Development And Classification
- Quality-System Operation
- Conformity Assessment
- Technical Documentation
- Registration And UDI
- Post-Market Surveillance And Vigilance
- Change And Market Maintenance
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
- medical-device manufacturers
- authorized representatives, importers, and distributors
- quality and regulatory teams
- clinical and post-market teams
- notified-body and conformity-assessment 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 consolidated legal position depends on amendments and transitional provisions. Software can maintain evidence and workflows but cannot determine legal classification, conformity, or market eligibility without accountable regulatory judgment.