How Often Is a PSUR Submitted?
According to the latest European Union Medical Device Regulation (EU MDR), every medical device manufacturer targeting the EU market with their products must compile and submit a periodic safety update report (PSUR) regularly. The main purpose of submitting this report to the Notified Body (NB) is to prove the safety and efficacy of your medical device.
The question that many manufacturers ask is, how often should a PSUR be submitted? This depends on the medical device and its stage of development.
Why You Need to Submit a PSUR
A PSUR is a critical document that establishes the effectiveness and safety of your medical devices throughout their lifespans. This report is part of the EU MDR requirements that you must comply with to sell medical devices in the EU. The report is meant to offer a realistic appraisal on how devices have performed across the globe, including a summary of all the complaints received since the last update.
The PSUR also provides a critical assessment of the benefit-to-risk ratio of your medical device. Through this assessment, you can easily determine whether you need to perform further studies or whether the product data suggests that changes should be made to the device. This is why it’s important to understand how to write a periodic safety update report. Fortunately, you can learn the most important aspects of the PSUR through the latest post-market surveillance medical device guidance offered by the EU MDR.
A PSUR is necessary whether or not your medical device has already been marketed in the EU. The most important elements of your PSUR include:
- Post-market surveillance data
- A description of your corrective and preventive actions (CAPAs) and the logic behind them
- A comprehensive benefit-to-risk evaluation including conclusions about the device
- Results of your post-market clinical follow-up (PMCF) study
- The devices’ sales volume and estimates of the number of users
- The frequency of usage
- An estimate and summary of the data listed above
These aspects of the PSUR are vital because the report isn’t just about checking boxes and clicking ‘Update.’ It’s designed to provide a proactive, continuous detailed analysis of all post-market data you’ve actively gathered over time. In other words, it’s an eloquent, regularly updated systematic review of the safety and usefulness of your medical devices.
The PSUR is intended to help the medical industry’s watchdogs and internal stakeholders appreciate the effectiveness and safety of your products throughout their intended life cycles. Therefore, the NB expects to receive a well-structured and professionally updated PSUR promptly.
Frequency of Submitting a PSUR
The frequency of submitting a PSUR depends on the regulatory classification of your medical device and the stage at which the development and marketing of the device are. For instance, for approved medical devices that have yet to be released to the market, you must submit a PSUR at least every six months after authorization until you place your medical device on the market.For devices that are already on market on the other hand, submission frequency is either at least every 2 years, or at least every 1 year, depending on the regulatory class. The same is true for IVDR products.
A report that covers the period during which the device is launched is considered to be the last of the six-month PSURs you’re required to submit before the “preliminary placement of the product on the market.” Note that the date of your initial placement should fall after the European Birth Date (EBD).
After the initial placement of your medical devices on the market, the subsequent PSURs should be submitted after six months for the first two years, annually for the subsequent two years, and every two years thereafter.
For devices on a six-month submission schedule, you can submit a request to the regulator or NB to move your submissions to annually if you want them to align with your EU signal detection submissions. You should submit your PSURs immediately if the VMD requests them on an ad hoc basis. Fortunately, you can agree with the regulator on the appropriate Data Lock Point (DLP) and submissions date, based on how urgently they need the report.
A different submission schedule may be set, especially when you’re requesting marketing authorization as a condition for approval, or because of serious safety concerns discovered during marketing.
For medical devices already on the market, the MDR requires PSUR submissions according to device risk class. Class IIa devices must submit a PSUR during Notified Body Conformity Assessment reviews. Class IIb non-implantable devices must also submit a PSUR during Notified Body Conformity Assessment reviews; however this must occur at least every 1 year. Class IIb implantable and Class III products must also submit a PSUR at least every year; however these PSURs can be submitted via EUDAMED, for Notified Body review.
For IVDR products, the requirements are similar. Class C IVDRs must submit a PSUR at least every year during Notified Body Conformity Assessment reviews. Class D IVDRs must also submit a PSUR at least every year; however they can be submitted via EUDAMED for Notified Body review.
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The frequency of submitting your PSUR is based on the initial marketing authorization date or previous marketing authorization dates like the EBD, EU Harmonized Birth Date (HBD), and International Birth Date (IBD). Once on the market, Annex IV of the MDCG 2022-21 industry guidelines outlines the PSUR Requirements clearly for all manufacturers who seek further guidance.