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Medical Device Technical File

Medical device regulation 2017 / 745 Annex II Medical device technical file is a summary document prepared by the manufacturer in a clear, well-organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the device in question.

 

The medical device technical file must be submitted to notified body or competent authority for review and approval. It should be preferably made in the English language or in an official language of an EU Member state. It must be available on request for the whole life cycle of the medical device (5 years for low-risk and 16 years for high-risk devices). Non-EU manufacturers must keep the file with the European Authorized Representative.

 

Irrespective of a medical device class, intended use, construction, and or safe history of the device, the manufacturer must have and keep up-to-date technical file and  documentation to demonstrate compliance with GSPR Annex I of medical device regulation 2017/745.

Medical device regulation has given specific requirements on what to include in your technical documentation. You can get more information from the below sections. Depending upon the Device construction there are various types of medical device technical file.

Medical Device Technical File Selection Criteria

Quality Assurance and Regulatory consulting team members are always confused or find it difficult in identifying the required number of technical file for the products planned for European CE Marking.

 

It is advised to remember that medical device technical file is all about your device to establish safety and performance. It means you cannot combine products with the different intended use, or different class, or different construction material, or even different design.

  • Device Intended use and Indication of use
  • Site of application
  • Design change or major constructional changes
  • State of the art

Medical Device Technical File Consultants

You cannot call anyone a master at medical device technical file preparation. We are a group of professionals experienced in EU Medical Device CE Marking covering core technical areas such as risk analysis, validations, design, shelf-life, usability, biological evaluation, safety, chemical characteristics, and clinical evaluation is called experts and such a group of experts makes us a team called I3CGLOBAL. You can directly contact us for technical file and documentation preparation.

  • Requirement & Identification as per CE Medical device regulation
  • Risk classification and identification of assessment route of CE Marking
  • Systematically organize and arrange Files and review.
  • Clinical Evaluation documentation covering PMS, PMCF & PSUR
  • Risk Analysis
  • Medical Device Quality Management System Implementation

Medical Device Technical File Types

  • Class I – Active Device, Non-Sterile with/without Software
  • Class I – Non-Active Device, Non-Sterile
  • Class I – Non-Active Device, Sterile / Measuring / Reusable
  • Class I – Active Device, Sterile / Measuring / Reusable
  • Class I – Software Device with or without Measuring Function
  • Class IIa – Active Device, Sterile / Non-Sterile / Measuring / Reusable /with / without Software
  • Class IIa – Non-Active Device, Sterile / Non-Sterile / Measuring / Reusable
  • Class IIa – Non-Active Device, Implant Sterile / Non-Sterile / Measuring / Reusable
  • Class IIa – Software Device, with or without Measuring Function
  • Class IIb – Active Device, Sterile / Non-Sterile / Measuring / Reusable with/without Software
  • Class IIb – Non-Active Device, Sterile / Non-Sterile / Measuring / Reusable
  • Class IIb – Non-Active Device, Implant Sterile / Nonsterile / Measuring / Reusable
  • Class IIb – Software Device, with or without Measuring Function
  • Class III – Active Device, Sterile / Non-Sterile / Measuring / Reusable with/without Software
  • Class III – Non-Active Device, Sterile / Non-Sterile / Measuring / Reusable
  • Class III – Non-Active Device, Implant Sterile / Non-Sterile / Measuring / Reusable
  • Class III – Active Device, Implant Sterile / Non-Sterile / Measuring / Reusable / with or without Software
  • Class III – Software Device, with or without Measuring Function
  • Special Rule – Class III – Devices incorporate medicinal product under rule 14
  • Special Rule – Class IIa/IIb – Devices for contraception under rule 15
  • Special Rule – Class IIa/IIb – Devices used for disinfecting, cleaning or sterilising medical device under rule 16
  • Special Rule  – Class III – Devices made using tissues or cells of human or animal origin, or their derivatives under rule 18
  • Special Rule – Class IIa/IIb/III – Nano-materials under rule 19
  • Special Rule – Cass IIa/IIb – Devices for medicinal inhalation under rule 20
  • Special Rule – Class IIa, Class IIb and Class III – Devices composed of substances that are absorbed or locally dispersed under rule 21

QMS Procedures linked with Technical Documentation

  1. Procedure for Device Classification
  2. CE Marking Procedure
  3. Labelling Procedure
  4. Vigilance Procedure
  5. Significant Change Notification Procedure