EU MDR & IVDR Regulatory Consulting
EU MDR 2017/745 & EU IVDR 2017/746 CE Marking
NKB Regovanta supports Medical Device and IVD manufacturers across the complete European regulatory lifecycle — from intended purpose, classification and conformity assessment through testing strategy, technical documentation, clinical or performance evidence, Notified Body readiness, CE marking and post-market compliance.
MEDICAL DEVICES – EU MDR 2017/745
Support across Class I, Is, Im, Ir, IIa, IIb and III Medical Devices, including implantable, active, software and custom-made devices.
- Product Classification & Conformity Assessment
- GSPR Compliance & Risk Management
- Clinical Evaluation (CEP & CER) & PMCF
- Technical Documentation (Annex II & III)
- Notified Body Strategy & Audit Readiness
- PMS, Vigilance, PSUR & FSCA
- MDD/AIMDD to MDR Transition
- EUDAMED & Economic Operator Support
IN VITRO DIAGNOSTICS – EU IVDR 2017/746
Support across Class A, B, C and D IVDs under Rules 1–7, with deep expertise in scientific validity, analytical performance and higher-risk scrutiny.
- IVDR Classification & Conformity Assessment
- Performance Evaluation Plan & Report (PER)
- Scientific Validity
- Analytical Performance
- Clinical Performance
- Performance Studies & Lab Strategy
- PMS, PMPF, PSUR & Vigilance
- IVDD to IVDR Transition & EUDAMED Support
Our Core EU Services
End-to-end guidance across every phase of qualification, testing, technical documentation, CE marking and post-market compliance.
Regulatory Strategy & Classification
Define regulatory pathway, classification, applicable rules and conformity assessment route under MDR or IVDR.
Learn moreTechnical Documentation & GSPR Compliance
Prepare and review technical documentation aligned with Annex II & III and applicable harmonised standards.
Learn moreClinical Evaluation & MDR Evidence Strategy
CEP, CER, literature strategy, clinical evidence gap analysis and PMCF planning tailored to device risk and claims.
Learn moreIVDR Performance Evaluation
Scientific validity, analytical performance and clinical performance integrated into a robust PER and PMPF.
Learn moreNotified Body Strategy & Audit Readiness
NB selection, application readiness, QMS readiness, audit preparation and response to NB findings.
Learn moreCE Marking & EU Registration
Conformity assessment support, EU Declaration of Conformity, CE marking and registration requirements.
Learn morePMS, PMCF/PMPF & Vigilance
PMS planning, PMCF/PMPF execution, PSUR, trend reporting, vigilance and FSCA support.
Learn moreEUDAMED & Economic Operator Support
SRN, actor registration, EUDAMED modules, data submission and UDI support for devices & IVDs.
Learn moreLegacy Device / Transition Support
MDD to MDR and IVDD to IVDR transition, gap analysis, technical file update and NB re-certification.
Learn moreChange Assessment & Lifecycle Support
Impact assessment for changes, supplements, renewals and ongoing compliance strategy.
Learn moreEnd-to-End Support Across the Product Lifecycle
The Regulatory Decision Chain: How strategy, evidence, files and Notified Bodies connect.
Strategy & Intended Purpose
Define intended purpose, device qualification & regulatory roadmap
Classification & Conformity
MDR rules / IVDR Rules 1–7 & conformity assessment route
Evidence & Testing Strategy
V&V, GSPR mapping, clinical evaluation (CER) & performance studies
Technical Documentation
Annex II & III dossier compilation, risk management & labeling
Notified Body Review & CE
Audit defense, deficiency resolution, DoC & CE marking
Post-Market Compliance
PMS, PMCF / PMPF, PSUR, vigilance & EUDAMED maintenance
Why Choose NKB Regovanta?
- Regulatory strategy before dossier preparation
- Technical documentation built for regulatory scrutiny
- Deep MDR & IVDR expertise across all risk classes
- Evidence-driven approach for MDR & IVDR success
- Strong relationships with leading Notified Bodies
- Lifecycle support beyond initial CE marking
Our Regulatory Expertise
Medical Devices (MDR)
- • Class I, Is, Im, Ir
- • Class IIa & Class IIb
- • Class III & Implantable Devices
- • Software as a Medical Device (Rule 11)
- • Custom-Made & System/Procedure Packs
In Vitro Diagnostics (IVDR)
- • Class A (Non-sterile & Sterile)
- • Class B & Class C Assays
- • Class D High-Risk (EURL / Common Specs)
- • Companion Diagnostics (CDx)
- • Self-Testing & Near-Patient Testing
Industries We Support
Build a Defensible EU MDR & IVDR Conformity Roadmap
We build regulatory strategies and technical documentation that drive CE Marking success and ensure long-term compliance in the European market.