Post Market Surveillance and Safety Update Reporting
Post Market Surveillance under EU MDR has been often overlooked in the scramble to re-certify. We have found a lack of PDF templates or even powerpoint presentations that provide actionable advice when it comes to creating PMS plans for MDR transitions. CiteMed has developed our own process for tailoring custom PMS plans to the different medical device classifications by making use of our internal software platform. You can chat with the team on this page, or book a free call and we’ll create an entire plan based around your product offerings.
Your New Post Market Surveillance Plan
In article 83 of the Regulation, it’s cited that ‘data gathered by the manufacturer’s PMS system shall be used’ for the following purposes:
- Updating the benefit-risk determination
- Update the design and manufacturing information, the instructions for use, labeling etc.
- Update Clinical Evaluation (Post Market Clinical Followup)
- Identify needs for preventive, corrective or field safety corrective action for the device
- Contribute to the PMS of other devices (when relevant)
- Detect and report trends as specified by article 88
The Need for Comprehensive Research
If you look closely at the above points, it becomes clear that a well executed and consistent review of current Scientific Literature (and Adverse Events) is a prerequisite. Without a means of discovering and compiling applicable new market information pertaining to your device it will be increasingly difficult to perform Post Market Surveillance at a high level year after year.
This is where a customized template and procedure can significantly increase your team’s efficiency for annual MDR filings. By implementing a Post Market Surveillance template you effectively standardize your submissions to the Notified Body. This not only makes creation/drafting of the reports more streamlined, but also increases the ease at which your Notified Body can review the reports.
What Do You Need Help With?
Use our consistent system and team to achieve a robust clinical evaluation and safety monitoring system that can be directly submitted to your Notified Body year after year.
Plan on Implementing your MDR PMS internally and just need some guidance? The team is happy to provide our free white papers as well as offer gap analysis/advisory consulting based on your specific product needs.
Let us construct and implement a complete research/event based PMS for your product lines that can be fully integrated into your existing vigilance and product reporting practices.