Want MDR-Ready Literature Reviews? Start Here.

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Fun fact: did you know that the word “literature” appears approximately 30 times in MEDDEV 2.7/1 rev.4?

If you’re involved in the preparation of Clinical Evaluation Reports (CERs), you are likely beginning to realize the important role that literature reviews play in meeting the new EU regulatory requirements slated to come into effect in May 2021.

As a fundamental component of CERs, literature reviews are used to:

  • Identify and evaluate safety and performance data;
  • Establish state of the art; and,
  • Monitor risks and reconfirm device risk profile.

One important thing to remember: each indication needs its own literature review, which can add up fast!

With regulatory bodies increasing their scrutiny of literature reviews and CERs in general, many organizations are looking for new ways to consistently deliver regulatory compliant, audit-ready literature reviews on time and on budget.

As with many things in life, the key to getting good results is starting with a strong foundation. That’s why our #1 tip for better literature reviews is:

Use the PICO framework to perfect your research question

Good literature reviews start with a rock-solid research question. Using the PICO framework will help ensure that your research question is effective.


PICO is a standard approach to crafting research questions for evidence-based medicine. It is highly effective when used to:

  • Create a clear question
  • Identify the information needed to answer that question
  • Translate the question into searchable terms
  • Develop and refine the search approach
  • Screen, summarize and appraise data

Once your question is established, the next step in your literature review is to track down any research that is potentially relevant. This can be a daunting task, which brings us to tip #2:

Enlist an information specialist for best results

Information specialists can be a huge asset to your review team. They know all the tricks for developing a search strategy that works! These may include things like:

  • Synonyms, singular/plural forms, verbal forms, adjectives, different spellings
  • Classification terms used by databases
  • Boolean search operators e.g.: ‘AND’, ‘OR’, ‘NOT’
  • Using a truncation symbol to look for all words starting with a particular combination of letters (use ‘$’ or ‘*’ depending on the database)

Coming up with a search strategy that effectively hones in on the relevant studies while minimizing the noise from irrelevant ones is definitely a job for an expert.

With regulatory bodies calling for continuous monitoring and assessment of safety data, particularly for compliance with MEDDEV 2.7/1 rev.4 in the EU, literature reviews are increasingly scrutinized for thoroughness, standardized processes, and data integrity. Follow these two tips, and your literature review will be off to a great start!



Dr. Isabella Steffensen
About the Author

Dr. Isabella Steffensen

Dr. Isabella Steffensen is a biomedical scientist and President of Thera-Business Consulting. Over the past 20 years, Dr. Steffensen has assisted pharmaceutical and medical device companies with technical, regulatory, marketing, and business development issues. She has extensive experience preparing clinical evaluation reports and other regulatory documents, as well as other evidence based-reports such as practice guidelines and systematic reviews.

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