Technical Files for Medical Devices & IVDs – MDR 2017/745 & IVDR 2017/746
At EUmAccess GmbH, we provide expert consultancy services to help manufacturers prepare and maintain Technical Files in compliance with EU MDR 2017/745 (Medical Devices) and IVDR 2017/746 (In Vitro Diagnostic Devices). Proper Technical Documentation is essential for CE Marking, regulatory approvals, and market access in the European Union.
What is a Technical File?
A Technical File (Technical Documentation) is a legally required document that demonstrates a device's safety, performance, and compliance with the relevant EU regulations. The file must be maintained throughout the device lifecycle and updated when necessary.
Required for all classes of medical devices and IVDs
Essential for CE Marking and conformity assessment
Reviewed by Notified Bodies (for higher-risk devices)
Must be available to Competent Authorities upon request
Technical File Requirements Under MDR 2017/745 & IVDR 2017/746
A complete Technical File includes the following sections:
Device Description & Specifications
- General product description
- Intended purpose & indications for use
- Device classification (MDR Annex VIII, IVDR Annex VIII)
- Unique Device Identification (UDI) system
Design & Manufacturing Information
- Design specifications & drawings
- Manufacturing process details
- List of all materials and components used
General Safety & Performance Requirements (GSPR) Compliance
- Demonstration of compliance with Annex I of MDR or IVDR
- Risk-benefit analysis and justification
- Verification & validation testing
Risk Management (ISO 14971:2019)
- Risk analysis, evaluation, and control measures
- Risk-benefit assessment
- Post-market risk monitoring
Clinical Evaluation (MDR) / Performance Evaluation (IVDR)
- For MDR: Clinical Evaluation Report (CER) in compliance with MDR Annex XIV
- For IVDR: Performance Evaluation Report (PER) including scientific validity, analytical & clinical performance
Pre-Clinical Testing & Biocompatibility
- Biocompatibility (ISO 10993)
- Electrical safety & electromagnetic compatibility (IEC 60601)
- Sterilization validation (ISO 11135, ISO 17665, ISO 11737)
Software & Cybersecurity (If Applicable)
- Software lifecycle documentation (IEC 62304)
- Cybersecurity risk assessment
- Artificial intelligence (AI) validation (if applicable)
Labeling & Instructions for Use (IFU)
- Device labeling requirements (UDI, language, and symbols)
- Instructions for Use (IFU) compliant with MDR/IVDR
- Packaging information
Post-Market Surveillance (PMS) & Vigilance
- PMS Plan & Periodic Safety Update Report (PSUR)
- Post-Market Clinical Follow-up (PMCF)
- Incident & field safety corrective action (FSCA) procedures
EUDAMED Registration & Declaration of Conformity
- Manufacturer & device registration in EUDAMED
- Declaration of Conformity (DoC) as per Annex IV
Who Needs a Technical File?
- Medical Device & IVD Manufacturers (EU & Non-EU)
- Non-EU Manufacturers (Must appoint an EU Authorized Representative)
- Importers & Distributors (Must ensure compliance before placing on the market)
Our Technical File Consultancy Services
Assisting in the creation of complete, IVDR/MDR-compliant documentation
- Identifying the correct IVDR risk classification (Class A, B, C, D)
- Determining the appropriate conformity assessment route
Gap Analysis & Compliance Audit
- Reviewing existing files for missing or outdated documents
Clinical & Performance Evaluation Support
- Helping with CER, PER & PMCF planning
Notified Body & Regulatory Submission Assistance
- Supporting communication with Notified Bodies & Competent Authorities
EUDAMED Registration & DoC Preparation
- Assisting in manufacturer & product registration
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.