Medical Device Technical Files for EU CE Marking

At MDS Denmark, we specialize in the preparation and management of Technical Files—or Medical Device Files—ensuring that your Technical Documentation complies with the EU Medical Device Regulation (MDR) 2017/745. Our services are tailored to meet the specific requirements of your medical device, whether it is software, sterile, or electronic, and are designed to align with both MDR and IVDR guidelines.

Our CE-Mark Services Include

Document Structure Setup

We set up a structured document system for your Technical File, considering product-specific requirements and ensuring that every Technical Document is organized for efficient review

Prefilled Technical File Templates

Our prefilled document templates are designed in accordance with MDR 2017/745 and relevant harmonized standards (e.g., IEC 62304 for software and IEC 60601 for electronic devices), streamlining the creation of your Medical Device File.

Comprehensive Training

We provide training on documentation to your personnel, ensuring they understand and can efficiently manage the Technical File.

Technical File Writing

Our experts assist in writing and compiling key sections of the Medical Device File, including:

  • Risk classification determination
  • General Safety and Performance Requirements
  • Device description (including software documentation as per IEC 62304)
  • Product requirements
  • Usability engineering file
  • Verification plan and report
  • Biocompatibility report
  • Risk management file
  • Post-market Surveillance Plan
  • EC declaration of conformity

Verification Testing Support

We assist in planning, tendering, and executing verification testing with accredited laboratories to ensure that your Technical Documentation is complete and compliant.

Clinical Evaluation and Design Review

We help prepare the Clinical Evaluation Plan and Report, and manage design reviews as per ISO 13485:2016 clause 7.3.5.

Registrations

We support product and actor registrations in the EUDAMED database and assist with UDI identifications, ensuring your Medical Device File is ready for market entry.

WHY CHOOSE MDS DENMARK FOR YOUR TECHNICAL FILE MANAGEMENT?

Our approach combines technical expertise with a comprehensive understanding of EU regulations. The Technical File is a crucial document for medical devices sold in the EU. It contains detailed information about the device—including its design, intended use, composition, and clinical evaluations—which is essential for proving conformity to regulatory requirements and obtaining the EU CE Mark.

The structure of a technical file typically includes

  • Device description and specifications, including the Unique Device Identification (UDI) number
  • Labeling and instructions for use
  • Detailed design and manufacturing information
  • General Safety and Performance Requirements (GSPR)
  • Benefit-risk analysis and risk management
  • Product verification and validation
  • Post-market surveillance (PMS) information

At MDS Denmark, we ensure that your Technical Files are meticulously prepared, structured, and maintained, meeting all necessary regulatory standards and requirements for the EU market.