EU MDR & IVDR Legacy Transition Consulting

Transitioning legacy products to the MDR/IVDR framework requires methodical gap identification across clinical data, risk management and GSPR evidence. We upgrade your legacy files into audit-ready CE packages.

Assess Your Transition Roadmap

10-Point Transition Remediation Program

Classification reassessment against MDR Annex VIII / IVDR Annex VIII rules

Conformity-assessment route impact & Notified Body scope confirmation

Annex II / III technical file gap assessment against new regulatory mandates

General Safety and Performance Requirements (GSPR) checklist remediation

ISO 14971 risk-management file overhaul & state-of-the-art updates

Clinical Evaluation (CER) / Performance Evaluation (PER) evidence gap closure

PMS, PMCF / PMPF, and PSUR infrastructure remediation

QMS updates aligned with MDR Article 10 & IVDR Article 10 mandates

Labeling, symbol updates, Basic UDI-DI assignment & EUDAMED readiness

Notified Body formal transition application, scheduling & audit defense

Senior-Expert Differentiator

Distinguish Documentation Gaps from True Evidence Gaps

We distinguish cosmetic documentation gaps from genuine clinical evidence gaps and regulatory strategy gaps. That prevents unnecessary, expensive rewriting and focuses your remediation budget exactly on what affects conformity and certification.

Transition Deadline Milestones

Regulation (EU) 2023/607: Extended MDR transition deadlines apply only if formal Notified Body applications and QMS agreements are signed in time.

Regulation (EU) 2024/1860: Phased IVDR transition deadlines contingent on active QMS and Notified Body lodgement.

Legacy File Remediation

Protect your market revenue by securing timely transition to MDR/IVDR.

Schedule Gap Analysis

Seamlessly Transition Your European Legacy Medical Devices & IVDs

Our remediation experts transform legacy Directive files into audit-ready MDR and IVDR conformity packages.

Book a Consultation