PSUR for Medical Devices under EU MDR: Guidelines for Preparation and Submission

The preparation and submission of Periodic Safety Update Reports (PSURs) are crucial responsibilities for medical device manufacturers under the European Union's Medical Device Regulation 2017/745 (MDR). This blog will explore the essential aspects of PSUR preparation, data collection periods, submission timelines, and special scenarios, ensuring compliance with the MDR.

What is the Role of Manufacturers in the Preparation and Submission of PSUR?

Manufacturers are responsible for preparing and updating PSURs, ensuring they are part of the technical documentation as outlined in Annex III of the MDR. For custom-made devices (CMD), this requirement is specified in Annex XIII.

Key Considerations for PSUR Preparation and Submission

1. Data Collection Period and Timeline

The data collection period for a PSUR begins on the device’s MDR certification date. If a device is not MDR-certified, the period starts on the MDR Date of Application (26 May 2021). This means that the PSUR requirements apply to all devices on the EU market and manufacturers should now be submitting these reports.
For the first PSUR, manufacturers can use historical data from PMS activities conducted before the MDR certification or Date of Application.
The period of coverage for the first PSUR may be adjusted and not cover exactly 12 or 24 months to avoid gaps or overlaps in data collection, ensuring continuity.

2. PSUR Preparation and Submission Timeline

The PSUR preparation timeline refers to the period required for the manufacturer to prepare and submit or make the PSUR available after the end of the data collection period.
Depending on the device class, the intention is to submit the PSUR to the Notified Body in the conformity assessment directly or via EUDAMED (European Database on Medical Devices), depending on the risk class of the device, or leading device where the PSUR represents a group of products. Whilst EUDAMED is being implemented, DQS requests that clients submit their PSURs directly to them.

3. PSUR Update Schedule

The schedule for PSUR updates includes the start and end of each data collection period, followed by the preparation and submission or availability of the PSUR.

When a legacy device becomes MDR certified without significant changes, the initial PSUR schedule under Article 120(3) MDR may continue, aligning with the MDR certification.

Submission of the PSUR

The manufacturer should submit the PSUR via EUDAMED; however, there have been delays in the roll out of the full functionality of this platform. Where PSURs must be proactively submitted, the submission should be made directly to the certifying Notified Body until EUDAMED is available. This applies to all Class III and all implantable devices (Class IIa or Class IIb). For other devices, the PSUR must be delivered on request to the Competent Authority or Notified Body. It is good practice to view the PSUR as a living document, updating it as new evidence becomes available, to be able to respond to this request in a timely manner.

Conclusion

The preparation and issuance of PSURs are vital to maintaining the safety and effectiveness of medical devices in compliance with MDR. By adhering to the guidelines on data collection, submission timelines, and specific scenarios, manufacturers can ensure that their PSURs meet regulatory requirements and contribute to the ongoing safety monitoring of their devices.

Author

Claire Dyson

has a doctorate in rational drug design and over 10 years of experience in medical devices that interact with or deliver medicines or biological responses. Most of her career has been spent in industry, mainly in Switzerland. She moved into certification bodies in 2018 and has been involved in several transformative change projects, including new accreditations and designations.