The literature research is an essential element of clinical evaluation. It typically requires a lot of work. This article will provide the best suggestions to help you efficiently complete and complete the research.
When conducting a literature review, the manufacturers collect scientific papers to provide evidence of the latest technology and prove the security, efficiency, and clinical benefits of their product.
Tip 1: Utilize the guidelines while searching for books
There are currently many MDCG documents regarding the clinical evaluation. However, none explains the steps to provide a literature search report to conduct the clinical assessment.
A) 2.7/1 Revision 4 of the literature search
The MEDDEV 2.7/1 is the main guideline for conducting a literature search within the MDR. According to the Medical Device, Coordination Group says the similar.
“For general guidelines on conducting the literature search, refer to MEDDEV 2.7/1 4. A5. Literature review and search protocol, essential elements.”
Section D, MDCG 2020-13
By researching literature, it is possible to find articles on the device being evaluated, the alternative device, the latest technology, and alternative exam and treatment strategies.
Annexe 5, in the MEDDEV 2.7/1 Revision 4, provides the most crucial points to consider when documenting your literature search. The guideline demands the purpose of the investigation (es) be documented. Examples of such goals include:
- Provide information on the device being evaluated (including the model number and the name of the device)
- Finding essential data to aid in effectively managing risk (focus specifically on the patient population and interventions in place)
- Informing the user about the assessment on the risk/benefit profile
- A brief overview of the current safety requirements for safety.
- Allowing a comparison of potential adverse effects
- Information about benchmarking devices
- Manufacturers must also document their techniques used to search for products.
- There will be more documentation in the following article.
B) MDCG documents
The MDCG documents don’t currently provide specific guidelines for conducting literature research. This document from the MDCG’s document for 2020-13 “Clinical evaluation assessment report template” is nonetheless beneficial:
It’s primarily targeted towards reviewers of clinical evaluations, especially the notified organizations; however, it also provides indirect guidelines to anyone who is evaluating a patient. Section D is devoted to research and literature reviews. The guidelines in the section are similar to those in the MEDDEV 2.7/1 Revision 4. The main focus is:
- Categories of search (e.g. device search, or modern technology, including clinical conditions)
- The scope of search strategies
- Review and search methods
- Literature search documentation
This MDCG 2020-13 document references MEDDEV 2.7/1 Revision 4. Therefore, you can save time reading the MDCG document and be happy that you’ll be able to continue using the MEDDEV 2.7/1 Revision 4, particularly about the literature search.
C) Other documents
Other documents that guide the formulation of the clinical assessment are, for instance, IMDRF MDCE WG/N57FINAL: 2019.
Tip 2: Document the literature search thoroughly
A) Literature search protocol
Failure to document the literature search can cause conformity. This could result in unnecessary requests or even deviances in the audit process, as stated in the MDCG document 2020-13 calls for notified bodies to examine the documents about the literature search. The composition requires reviews to assess the metadata that follows:
- Search terms
- Databases used
- Criteria for inclusion and exclusion
- Elimination of duplicates
- Review of literature and documentation
- Methods for searching
These metadata are included in the protocols for searching the literature.
MDCG 2020-13 requires auditors to pay a particular focus on the exclusion requirements.
The clinical evaluation must be clear about the criteria for selection and the purpose of regulation intended to serve. The CER must clearly distinguish between two kinds of information (device under examination and an alternative device current technology or alternative treatment options). If the information does not correspond to one, then explain the data’s inclusion.
Section D, MDCG 2020-13
MDCG 2020-13 requires that manufacturers establish and record the selection criteria for literature search. The criteria for selection must be defined about the overall clinical assessment and differentiate between two searches conducted for data or information.
Look for the latest in technology.
Search for the device under evaluation/equivalent device
You can read more information about these two search results in tip 3.
(b) Additional documentation
The complete documentation of the literature search does not just contain the protocol for conducting a literature search.
The documentation contains all of the following documents:
- Literature search protocol
- The report of the literature search includes all deviations to the search protocol and the result of the hunt.
- Complete list of articles retrieved.
- Complete list of items excluded along with the reasons for their exclusion
- Full-text versions of pertinent documents
Tip 3: Keep in mind that there is much literature-based research
It is not up to you to pick what to search for. The MEDDEV 2.7/1 Revision 4 requires that your literature search include at least two areas:
You will require a current search to prove the latest technology for your device and assess your device against others.
You require the declarations on your device (or an equivalent device) to prove your device’s security, performance, and clinical benefits.
Tip 4: Make use of (Boolean) operators
Utilizing (Boolean) operators let you narrow your literature search. This will save you from the hassle of reading literature that isn’t specific to your needs. However, you could use Boolean operators to expand your search, mainly if you cannot find good literature sources.
The operators can mix different search terms based on the context. The most popular Boolean operators comprise AND, OR and NOT.
Combining words with “AND” filters the results for all terms searched for.
Combining terms using “OR” filters the results to display entries that include one of the terms you are searching for.
Then, combing the terms using “NOT” excludes entries with this phrase out of your results.
Round brackets and quotation marks can also help improve the quality of the results of a search. Utilize them to find precise and relevant search results.
If you include the search term, you want to use within quotes,” The search engine can look for your search terms within the exact order and context.
Round brackets () identify a Boolean operator to units or terms.
(Related Article – LITERATURE SEARCH FOR CLINICAL EVALUATION)
Tip 5: Don’t go through the entire text of all the results from a search.
Literature searches often yield hundreds of publications. In this instance, you might be wondering if it is essential to study the entire content of each publication.
It is important to note that you (still) do not have to read the complete text of the documents you’ve got that you find in your initial search. You can exclude irrelevant publications based on the abstract if they’re not connected to the clinical evaluation, and in particular, do not involve the instrument under examination.
Summary and Conclusion
It would be best if you continued to utilize MEDDEV 2.7/1 Rev. 4 as a reference guide to conduct literature research. This MDCG 2020-13 document is a reference to the guidelines in MEDDEV 2.7/1 Rev. 4 and urges clinical evaluation reviewers to pay particular attention to the following subjects:
- Literature search documentation
- The full-text publication is available
- The completeness of meta-information (e.g. the criteria for inclusion or exclusion)
Limit the range and the particularity of the articles you find in your literature search with the help of (Boolean) operator. You can save time by removing irrelevant articles early, especially in cases where they are not relevant to the current state of technology or the device in development.
Keep in mind that you should also study the details on comparable devices in addition to the latest state-of-the-art technology. Also, you should conduct at minimum two search results.
If you follow the suggestions provided in the article, you’ll comply with the MDR’s requirements for research in the literature. Still, if you need any kind of expert assistance, you can contact us.
