Technical Documentation

EU Medical Device Regulation 2017/745 (EU MDR)

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.

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.

Key Points:

Annex II contains the technical documentation and Annex III contains the technical documentation on post-market surveillance
The technical documentation and the EU declaration of conformity are drawn up and kept up to date
Manufactures should ensure state of the art standards and guidance are considered when compiling the technical documentation
It is highly recommended to have a summary of technical documentation as proposed by the position Paper of the Team Notified Body to provide context to the holistic technical documentation

Our Service

Process and Templates Development

Gap Assessment

Implementation

Continuous update of documentation