Technical Files (EU) MDR745/ IVDR746

Europe-CE Marking MDR / IVDR

Technical Files for Medical Devices & IVDs – MDR 2017/745 & IVDR 2017/746

At Alpine Quality Consultants, 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)

Labelling & 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

Technical File Preparation & Review

Assisting in the creation of complete, IVDR/MDR-compliant documentation

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

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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