EU IVDR 2017/746
Regulatory Consulting
for In Vitro Diagnostics
Specialized regulatory support for IVD manufacturers across Class A, B, C and D under Regulation (EU) 2017/746. NKB Regovanta connects scientific validity, analytical performance, clinical performance and performance evaluation into a robust compliance pathway.
IVDR 2017/746 Evidence Sequence
Intended Purpose → Rule 1–7 → Scientific Validity → Analytical → Clinical → PER → PMPF
IVDR Specialists
Expertise across Class A to D under Rules 1–7
Performance Evaluation
Excellence in PEP, PER & PMPF evidence design
Lab Coordination
Analytical protocol review & study strategy
Notified Body Readiness
Pre-assessment & deficiency resolution
Lifecycle Compliance
PMS, PMPF, PSUR & EUDAMED maintenance
Our IVDR Regulatory Support
Comprehensive performance evaluation, analytical testing strategy and technical documentation under IVDR 2017/746.
IVDR Classification (Class A, B, C & D)
- •Classification under IVDR Rules 1–7
- •Intended purpose assessment & analyte review
- •Risk & public health impact evaluation
- •Conformity assessment route planning
Technical Documentation (Annex II & III)
- •Annex II Technical Documentation compilation
- •Annex III PMS documentation
- •GSPR mapping & evidence matrix
- •Device description & design information
GSPR & Risk Management
- •GSPR applicability assessment
- •Risk management aligned with ISO 14971
- •Risk mitigation & verification records
- •Benefit-risk evaluation & residual risk
Performance Evaluation Plan (PEP)
- •PEP development per Annex XIII
- •Performance claims mapping to state of the art
- •Evidence requirements & study identification
- •Study strategy & acceptance criteria
Scientific Validity
- •Association with clinical condition/marker
- •State-of-the-art literature review
- •Scientific validity report compilation
- •Evidence adequacy & rationale
Analytical Performance
- •Precision, repeatability, reproducibility
- •Analytical sensitivity & analytical specificity
- •Interference, cross-reactivity & carry-over
- •Measuring range, cut-off, specimen stability
Clinical Performance
- •Clinical performance strategy & diagnostic endpoints
- •Clinical performance studies & target population
- •Study protocol support & comparator selection
- •Clinical performance data evaluation & statistics
Performance Evaluation Report (PER)
- •PER development integrating 3 evidence pillars
- •Integration of all scientific & clinical evidence
- •Performance claims substantiation
- •Lifecycle updates & PMPF triggers
Performance Studies & Lab Coordination
- •Analytical & clinical study design
- •Lab selection & protocol review
- •Data review & report alignment
- •GLP / GCP & regulatory considerations
PMPF (Post-Market Performance Follow-up)
- •PMPF Plan linked to residual uncertainties
- •PMPF Evaluation Report compilation
- •Continuous performance monitoring
- •Benefit-risk updates across lifecycle
PMS, PSUR & Vigilance
- •PMS Plan & PMS Report for Class A/B
- •PSUR compilation for Class C/D
- •Vigilance & trend reporting systems
- •Field Safety Corrective Actions (FSCA)
Class D IVD Strategy & EURL Scrutiny
- •Class D regulatory pathway rationale
- •Reference lab (EURL) & batch testing considerations
- •Common Specifications (CS) compliance
- •Notified Body strategy for Class D
Notified Body Strategy & Audit Readiness
- •NB selection & application scope
- •Technical file pre-assessment
- •Mock audits & interview preparation
- •NB findings response & CAPA support
EUDAMED & Economic Operators
- •SRN & actor registration support
- •Manufacturer & EC REP registration
- •EC REP, Importer, Distributor mandates
- •UDI-DI & Basic UDI-DI management
IVDD to IVDR Transition
- •Gap assessment against IVDR requirements
- •Classification changes (85%+ need NB review)
- •Technical file remediation & PER build
- •Transition roadmap & Article 110 compliance
Change Assessment & Lifecycle Support
- •Change impact assessment for reagents & assays
- •Performance claim impact evaluation
- •NB notification assessment
- •Technical file & PER updates
Our IVDR Regulatory Process
The 3-pillar evidence model: Scientific Validity → Analytical Performance → Clinical Performance.
Strategy & Intended Purpose
Classification (Rules 1–7)
Scientific Validity
Analytical Performance
Clinical Performance (PER)
Notified Body Review & CE
Why Choose NKB Regovanta for IVDR?
- Deep expertise across Class A to Class D IVDs under Regulation (EU) 2017/746
- Evidence matrix linking each performance claim directly to laboratory data
- Specialized understanding of Common Specifications (CS) and designated EURL scopes
- Seamless connection of Scientific Validity → Analytical → Clinical Performance
- Laboratory protocol review from the Notified Body technical review perspective
- Rigorous PMPF and post-market surveillance systems to safeguard CE certificates
Evidence-Driven PER & Study Protocols
Under IVDR, over 85% of IVDs require Notified Body certification. We build the evidence matrix linking each performance claim directly to laboratory data, ensuring effortless Notified Body approval.
Schedule an IVDR ReviewIVD Technology Expertise
Proven analytical and clinical track record across advanced assay formats.
Ready to Master EU IVDR 2017/746 Compliance?
We guide IVD manufacturers from early classification to Notified Body defense and CE mark issuance.