EU MDR 2017/745
Regulatory Consulting
for Medical Devices
End-to-end regulatory support for Medical Devices across Class I, Is, Im, Ir, IIa, IIb and III under Regulation (EU) 2017/745. NKB Regovanta connects regulatory strategy, testing, clinical evidence, technical documentation and Notified Body readiness to help you achieve and maintain CE marking with confidence.
MDR 2017/745 Evidence Sequence
Intended Purpose → GSPR → Risk → Clinical Evaluation → CER → Notified Body Review → CE Marking
MDR Specialists
Deep regulatory expertise across all device classes
End-to-End Support
From classification to post-market lifecycle
Notified Body Readiness
Pre-assessment, mock audit & deficiency defense
Testing Strategy
V&V and laboratory coordination
Global Clients
Proven track record across medical technologies
Our MDR Regulatory Support
Comprehensive technical and clinical consulting across all 12 areas of European medical device compliance.
MDR Classification & Conformity Assessment
- •Classification (I, Is, Im, Ir, IIa, IIb, III)
- •Conformity assessment route determination
- •Notified Body involvement planning
- •Borderline & combination product considerations
Technical Documentation (Annex II & III)
- •Annex II Technical Documentation compilation
- •Annex III PMS documentation
- •Device description, variants & design history
- •GSPR mapping & evidence matrix
- •Verification & validation summary
GSPR & Risk Management
- •GSPR applicability assessment
- •Risk management aligned with ISO 14971
- •Hazard analysis & risk control measures
- •Benefit-risk determination & residual risk
Testing Strategy & Lab Coordination
- •Biocompatibility (ISO 10993) & Sterilization
- •Electrical safety & EMC (IEC 60601)
- •Software (IEC 62304) & Cybersecurity
- •Usability (IEC 62366), Packaging & Shelf life
- •Bench & mechanical performance testing
Clinical Evaluation & CER
- •Clinical Evaluation Plan (CEP)
- •Clinical Evaluation Report (CER)
- •Literature search protocol & documented appraisal
- •Equivalence assessment across tech/bio/clinical
- •Clinical evidence gap analysis & sufficiency
PMCF (Post-Market Clinical Follow-up)
- •PMCF Plan targeted to residual uncertainties
- •PMCF Evaluation Report compilation
- •PMCF user survey & registry strategy
- •Post-market clinical data collection governance
Notified Body Strategy & Audit Readiness
- •NB selection, scope & application readiness
- •QMS & technical file pre-assessment
- •Mock audits & reviewer interview prep
- •Deficiency response & root-cause analysis
- •CAPA support & certificate maintenance
CE Marking & Declaration of Conformity
- •EU Declaration of Conformity preparation
- •CE marking strategy & execution
- •UDI assignment & labeling verification
- •Economic operator obligations (EC REP, Importer)
- •Registration & EUDAMED alignment
PMS, PSUR & Vigilance
- •PMS Plan & PMS Report compilation
- •PSUR (Periodic Safety Update Report) for IIa/IIb/III
- •Vigilance & serious incident trend reporting
- •Field Safety Corrective Action (FSCA) support
EUDAMED & Economic Operators
- •SRN & actor registration support
- •Manufacturer & Authorized Representative data
- •EC REP, Importer, Distributor mandates
- •UDI-DI & Basic UDI-DI management
MDD/AIMDD to MDR Transition
- •Legacy device gap assessment
- •Technical file remediation to MDR standards
- •Clinical evidence & CER upgrade
- •QMS updates & Article 120 transition roadmap
Change Assessment & Lifecycle Support
- •Design & manufacturing change impact assessment
- •Notified Body notification trigger review
- •Technical file & CER updates
- •Annual renewal & ongoing compliance maintenance
Our MDR Regulatory Process
A disciplined sequence connecting strategy, evidence, files, audits and lifecycle maintenance.
Strategy & Intended Purpose
Classification & Conformity
Testing & Clinical Evidence
Technical Documentation
Notified Body Review & CE
Post-Market Surveillance
Why Choose NKB Regovanta for MDR?
- Regulatory strategy drives everything we do — no template filling
- Deep expertise across all MDR device risk classes (I, IIa, IIb, III)
- Testing strategy aligned directly with GSPR and clinical claims
- Clinical evidence that stands up to aggressive Notified Body scrutiny
- Strong working relationships with leading European Notified Bodies
- End-to-end lifecycle support beyond initial CE marking
- Global experience across diverse medical technologies
Defensible Evidence, Not Just Documentation
A technically complete report can still create major nonconformities if clinical claims, risk management and GSPR are not tightly harmonized. We ensure your submission file withstands the most rigorous Notified Body audit.
Schedule an MDR ReviewTechnology Expertise
Deep clinical and engineering understanding across complex medical device domains.
Ready to Accelerate Your EU MDR 2017/745 Clearance?
From early GSPR mapping to final CE certificate issuance, our consultants lead the way.