Lesson 9 – Systematic Literature Review Course: Most Common Notified Body Feedback During Audits

Missed last week? Read our Past Lesson: Are you a qualified reviewer?. Be sure to check it out if you haven’t already!

How to Avoid Common Pitfalls in Literature Reviews

As many of you know, submitting literature reviews for medical devices under the EU MDR (Medical Device Regulation) can be a complex process. And when Notified Bodies step in for audits, they often provide feedback that can be both helpful and, at times, challenging to navigate.

Over the years, our team at CiteMed has handled numerous submissions and reconciled findings from audit results. We’ve seen the same issues come up again and again during these audits, and we want to share these insights with you so you can avoid common pitfalls and improve your chances of a smooth review process.

In this post, we’ll cover the most frequent feedback from Notified Bodies, how you can proactively address these concerns, and why following best practices can make a significant difference in your submission process.

Our published article on this can be read here. Below are summaries of the most important concepts, but we recommend reading the full article.

1. Is Your Search Reproducible?

One of the most common pieces of feedback we see from Notified Bodies is related to the reproducibility of the search protocol. Often, auditors struggle to understand how the literature review was conducted, making it difficult for them to verify the search results.

Your Search Protocol needs to be clear, precise, and fool-proof. Ideally, any person who picks it up should be able to follow the steps exactly and achieve the same results. If your search protocol is lacking or unclear, it could be a major red flag during an audit.

To help ensure your protocol is robust, we’ve created a Search Protocol Template that you can follow. You can also access it through the CiteMed platform, which automatically generates search protocols for your projects.

Tip: A strong protocol can be the difference between passing an audit with minimal issues and facing repeated questions about your process.

2. Are the Results the Same? Notes on Search Validation

Validation is another area where issues commonly arise. The concern here is that the results you present in your literature review may differ from the results the auditor retrieves when running the same search terms and date ranges.

It’s important to remember that literature databases are constantly updated. As a result, the search results may change slightly by the time an auditor runs the same search. So, how do you address this potential issue?

The best solution is to maintain a thorough Audit Trail. At CiteMed, we build this in automatically, but you can also recreate it manually if needed. When you perform your searches, be sure to:

• Label and export the raw search results
• Timestamp the files
• Store the files in a dedicated folder

This ensures that when the auditor asks about validation, you can provide them with the exact search results that were used in your review.

3. PRISMA: A Critical Element

Although the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) charts are not explicitly required in any regulations (to my knowledge), they’ve become an increasingly expected component of literature reviews in Europe. Notified Bodies often look for these charts in submitted reviews.

PRISMA charts offer a clear overview of your review process, showing how you identified and selected studies, along with how you handled duplicates. Including a PRISMA flowchart not only helps organize your review but also ensures transparency during the audit.

If you’re unsure how to create one, don’t worry. CiteMed can automatically generate these charts for you, but you can also create them using Excel or other tools with some proficiency.

4. Conclusion: The Key to Success

As you’ve learned, most of the negative feedback during an audit doesn’t revolve around the content of your literature review but rather its format and execution. To avoid common mistakes and ensure a smooth review process, focus on the following:

• Keep your search protocol organized and reproducible.
• Ensure search results are clearly validated and backed by an audit trail.
• Include a PRISMA flowchart to document your review process.
• Follow a structured, transparent approach to maintain credibility.

By addressing these aspects early in your process, you can avoid significant delays and complications during your Notified Body audit.

Stay Ahead: Proactive Steps for Submission Success

If you want to ensure you’re fully prepared for your next Notified Body audit, we recommend taking the following proactive steps:

• Document everything: From search protocols to final reports, make sure you have all your processes and results well-documented.
• Use tools like CiteMed: Automate parts of your process to save time and avoid mistakes.
• Stay up to date: Keep yourself informed about the latest industry standards and updates to EU MDR regulations.

In next week’s lesson, we’ll dive deep into how literature reviews for in vitro diagnostic devices (IVDR) differ from standard medical device reviews, so stay tuned!

Until next time,

Ethan Drower
Co-Founder, CiteMed

By addressing these common pitfalls, you’ll be able to streamline your submission process and avoid unnecessary feedback from Notified Bodies. Let’s make sure your literature reviews are as efficient and effective as possible.