Ensure Compliance & Market Approval with EUmAccess GmbH
At EUmAccess GmbH, 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 |
| Device Description & Specifications |
| Usability & Software Validation (SaMD) |
| UDI & Labeling Compliance |
| Post-Market Surveillance (PMS), PMCF & PSUR Reports |
| Declaration of Conformity (DoC) & Certificates |
Why Choose EUmAccess GmbH?
- Regulatory Experts – Specialized in MDR, IVDR & Notified Body Requirements
- Thorough & Efficient Reviews – Reduce submission rejections & delays
- Tailored Compliance Solutions – Support for all risk classes (I, IIa, IIb, III)
- End-to-End Support – From file preparation to Notified Body submission
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.