Technical Documentation under EU MDR
General Background
Technical documentation under the EU Medical Device Regulation 2017/745 (EU MDR) refers to a set of documents that manufacturers must prepare and maintain to demonstrate the conformity of their medical devices with the requirements of the regulation. The technical documentation serves as a comprehensive record of the design, manufacture, and testing of the medical device and must be available for review by the Competent Authorities. The EU MDR requires manufacturers of medical device draw up and keep up to date technical documentation in accordance with Annex II and III of EU MDR.
The technical documentation must include all relevant information on the medical device, including its design, performance, intended use, and clinical evaluation. It must also include information on the manufacturing process, packaging and labeling, instructions for use, and any post-market surveillance data.
This documentation includes:
- Device description
- Information to be supplied by the manufacturer
- Design and manufacturing information
- General safety and performance requirements (GSPR)
- Benefit-Risk Analysis and Risk Management
- Product Verification and Validation
- Post-market surveillance plan in Post-market clinical follow-up plan
- Post-market follow-up report
- Post-market surveillance report or Periodic Safety Update Report
The technical documentation is required to be maintained throughout the device lifecycle and expected to be indexed using an aligned, structured format, as proposed in the position paper of the Team Notified Body (see https://www.team-nb.org), which helps to guide the reviewer and provide additional context to the relationship of documents within the technical documentation.
The technical documentation includes the entirety of the evidence for the subject device. It includes the subject device design, development, verification and validation and market history.
The content of the technical documentation will depend on the nature of the device. The technical must include a risk management file, which details the measures taken to mitigate potential risks associated with the device. Additionally, the EU MDR requires manufacturers to maintain a post-market surveillance plan, which outlines the steps that will be taken to monitor the safety and performance of the device once it is on the market. It is intended to be a living document that is updated throughout the life cycle of the device.
The EU MDR requires that technical documentation be written in a clear, concise, and readily understandable language, and that it be updated and maintained throughout the life cycle of the device. The technical documentation must also be organized in a way that allows Competent Authorities and/or other third parties to quickly and easily assess the conformity of the device with the requirements of the applicable regulation. Specifically, we recommend PDFs should be compiled ensuring optical character recognition (OCR) has been performed.
Under the EU MDR, manufacturers shall keep the documentation available for competent authorities for 10 years after the last device has been placed on the market. For implantable devices, this minimum period is 15 years.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below, and which are relevant to the major changes introduced by the EU MDR.
Key points
Our Services
Training
AKRA TEAM offers training on drafting technical documentation to meet the expectation of EU MDR and avoid common reasons for delays in technical documentation reviews by notified bodies.
Process and Templates Development
AKRA TEAM has proven procedure and document templates available for all aspects of the technical documentation including:
- Summary of technical documentation acc. to Team NB position paper
- Device description
- IFU and device labels
- Design and manufacturing documentation
- General Safety and Performance Requirements checklist
- Risk management file documentation
- Verification and validation documentation
Gap Assessment
AKRA TEAM offers comprehensive gap assessments of technical documentation to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
Implementation
AKRA TEAM has an experienced team of medical writers, clinicians and regulatory experts available to write all aspects of technical documentation for all device categories and risk-classes. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer. Additionally, if the technical documentation is currently under review we can provide targeted updates based on any open deficiencies.
Continuous update of documentation
AKRA TEAM additionally offers solutions for continuous documentation updates and review of technical documentation. AKRA TEAM will schedule and revise documentation at defined intervals to ensure regulatory compliance is maintained according to the expectations of EU MDR.
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