Medical Device Technical Files for EU CE Marking

At MDS Finland, we specialize in the preparation and management of technical files for medical devices, ensuring compliance with the EU Medical Device Regulation (MDR) 2017/745. Our services are tailored to meet the specific requirements of your medical device, whether it's software, sterile, or electronic.

OUR SERVICES INCLUDE

Document Structure Setup

We set up a structured document system for the technical file, considering product-specific requirements.

Prefilled Technical File Templates

Our prefilled document templates are in accordance with MDR 2017/745 and relevant harmonized standards such as IEC 62304 for software and IEC 60601 for electronic devices.

Comprehensive Training

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

Technical File Writing

  • 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.

Clinical Evaluation and Design Review

We help in preparing 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.

WHY CHOOSE MDS FINLAND 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 design, intended use, composition, and clinical evaluations. It’s essential for proving conformity to regulatory requirements and obtaining CE Marking.

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 Finland, we ensure that your technical files are meticulously prepared, structured, and maintained, meeting all necessary regulatory standards and requirements for the EU market.