Europe-CE Marking MDR / IVDR

Technical File (TF) Review for MDR 2017/745 & IVDR 2017/746

Ensure Compliance & Market Approval with AQC

At AQC, we provide comprehensive Technical File (TF) review services to help medical device (MD) and in vitro diagnostic (IVD) manufacturers achieve compliance with EU MDR 2017/745 and IVDR 2017/746. Our expert team ensures that your technical documentation meets Notified Body (NB) requirements, facilitating smooth CE marking, EUDAMED registration, and regulatory approval.

Why is a Technical File Review Important?

Mandatory for CE Marking

Essential for conformity assessment under MDR & IVDR

Ensures Compliance

Avoid regulatory delays & non-conformities

Streamlines Notified Body Review

Reduces risk of rejection & re-submissions

Supports Market Access

Ensures smooth entry into the EU market

Our Technical File (TF) Review Services

Pre-Assessment & Gap Analysis

  • Conduct a detailed gap analysis of your technical file
  • Identify missing or non-compliant documentation
  • Provide a compliance roadmap for MDR/IVDR readiness

Documentation Review & Validation

  • General Safety & Performance Requirements (GSPR) compliance check
  • Verify clinical evaluation reports (CER) & performance evaluation reports (PER)
  • Assess risk management documentation (ISO 14971:2019)
  • Review Post-Market Surveillance (PMS), PMCF, and PSUR requirements

Technical File Compilation & Formatting

  • Assist in compiling a structured, NB-ready technical file
  • Ensure compliance with Annex II & III of MDR/IVDR
  • Validate UDI, labeling, IFU, and product claims

Notified Body & Competent Authority Support

  • Support in Notified Body interactions & submission process
  • Assist with corrective actions & responses in case of queries or rejections
  • Provide regulatory justifications and documentation clarifications

Key Documents Reviewed

  • Device Description & Specifications
  • Intended Use & Classification Justification
  • GSPR Checklist (Annex I of MDR/IVDR)
  • Risk Management Documentation (ISO 14971:2019)
  • Clinical Evaluation Report (CER) / Performance Evaluation Report (PER)
  • Biocompatibility & Toxicology Data
  • Usability & Software Validation (SaMD)
  • UDI & Labeling Compliance
  • Post-Market Surveillance (PMS), PMCF & PSUR Reports
  • Declaration of Conformity (DoC) & Certificates
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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