Navigating Compliance: Understanding MDR Medical Device Technical Documentation

The European Union’s Medical Device Regulation (MDR) stands as a comprehensive framework ensuring the safety and efficacy of medical devices within its jurisdiction. At the heart of MDR compliance lies the intricate and pivotal document known as the technical documentation. This crucial compilation of data and information offers a comprehensive record of the entire trajectory of a medical device, spanning from its initial conception to its entry into the market.

The technical documentation is, in essence, a dossier that encapsulates the entire life cycle of a medical device. The dossier delineates the specifics of the design, manufacturing processes, performance characteristics, risk assessment and technical specifications of a medical device. These particulars align with the criteria set by EU Medical Regulations, providing the groundwork for the assessment of the device’s adherence to safety and performance standards.

Section 4.2.3 Medical Device File of ISO 13485:2016 states the following.

“For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements.”

The responsibility for compiling and maintaining the technical documentation rests squarely on the shoulders of the device manufacturer. The technical documentation is not a one-time creation but a living file that must be regularly updated to reflect changes in the device, manufacturing processes, or relevant standards. The technical documentation is kept for 10 years from the date the product is placed on the market (unless explicitly specified otherwise). This dynamic nature ensures that the document remains an accurate and current representation of the device’s compliance status.

For certain classes of medical devices, the technical file becomes a focal point of interaction with Notified Bodies—a third-party entity designated by an EU member state to assess conformity. Manufacturers often submit the technical file to Notified Bodies as part of the conformity assessment process.

Here at QReg our assistance is available to provide support to manufacturers as we recognise the challenges faced in developing and managing technical documentation. This is achieved by our standardised technical documentation template that has been audited and approved by BSI.