State Of The Art Literature Reviews
Top Reasons they lead to Non-Conformances
Under the MEDDEV 2.7/1 rev 4 regulations that came into effect on May 26, 2021, literature reviews play an important role in several areas of the CER, including establishment of State of the Art (SOTA). Therefore, anyone involved in Clinical Evaluation Reports (CERs) for medical devices will find themselves undertaking many more literature reviews.
The state of the art “describes what is currently and generally considered standard of care, or best practice, for the medical condition or treatment for which the device is used.” This is central to the CER and its best practice to dedicate a section of the CER to establishing the SOTA. You can then reference as needed throughout.
A considerable amount of the data that supports the SOTA comes from reviewing published literature for relevant information. You must conduct the SOTA literature review systematically, using sound and objective methods, according to the guidance provided by the regulators.
However, there are many issues that can arise in the literature review process, which will also increase the risk of failing an audit.
The Search
A State of the Art (SOTA) literature review is a thorough investigation and analysis of the most up-to-date knowledge, advancements, and trends of medical devices. This type of review aims to provide a comprehensive understanding of the current landscape, including the latest technologies, regulatory changes, clinical studies, and emerging innovations related to medical devices. It serves as a valuable resource for researchers, manufacturers, and regulatory authorities to stay informed about the cutting-edge developments in the medical device industry.
Research methodology must be valid. It is advisable to use a framework such as PICO and set out each aspect of the search. It is important to formulate a research question.
We must show all potentially relevant articles in the results. If anything considered relevant is missing, it can raise the question of validity within the entire literature review.
The Proof
Despite the availability of literature review software, spreadsheets remain a big part of the review process in many organisations. But, as handy as they are, spreadsheets can’t keep track of connections between data and source documents, timestamps, proof of participation, or provide version control. When the Notified Bodies ask, you’ll need to produce this type of data to verify that you conducted the literature review thoroughly and with full adherence to a prescribed process.
Ensure that there is search and appraisal evidence. The appraisal plan needs to be clear and applied consistently and all searches should be saved. Any excluded articles also need to be listed and reasons why they have been omitted given.
The Process
Manufacturers should define a literature search protocol that scopes out the plan, clarifies any problems, and conforms with existing guidelines before beginning the search. The guidance provided in MEDDEV 2.7/1 rev 4 calls for a systematic approach to literature reviews. Many reviews lack the thorough, documented process that the notified bodies are looking for. The data should be reported in a scientific manner, avoiding an bias.
When updating the CER, it is expected that the manufacturer will repeat literature searches to identify new data on the device under evaluation but also to verify that the device remains the state of the art, as discussed in section 3.1.1 above. This is also a requirement of the PMS plan per Annex III. Therefore, it’s vital for manufacturers to build a solid literature search technique that we can readily repeat and validate throughout future CER revision. Ultimately, if you gave the process to someone who wasn’t involved in the literature search, would the same result occur?
The Data
Manufacturers must consult applicable standards and guidance documents in the corresponding medical device field to determine the current state of the art. Using information on the medical condition managed with the device, benchmark devices, and medical alternatives available to the target population would be beneficial.
You also need to ensure that you have adequate justification for the selection of databases used and their suitability. There are results filters that can provide SoTA filter justifications and give an overview of the initial generation of search syntax and justification of its suitability.
Scientific databases are required, and not ‘grey’ databases such as internet searches, non-published data, and citations. CER’s commonly use scientific databases such as Cochrane, EMBASE, Pubmed, CHINAHL, SCOPUS, Cochrane Library or PROQUEST databases for literature search.
The Efficiency
The use of automated software can undertake tasks such as data collation and report preparation. The higher the number of required literature reviews, the more important it is to manage the workload more efficiently. By automating repetitive takes, it can make the review process quicker and produce better quality data.
In the literature review, any mistake can be disastrous. Typos, inconsistencies in data entry, transcription errors, or undocumented manual decisions can all negatively affect your literature review. You should implement proper tools to negate these possibilities.
CLIN-r+ Recommendations
Medical device producers will face stricter regulations due to the introduction of EU MDR. The Clinical Evaluation workflow is the area where the standards have increased the most, placing the expectations high for medical writers. Getting experienced CER writers and consultants onboard early improves the likelihood of executing a SOTA and CER to ensure a successful NB audit.
Always remember that a SoTA is free clinical data. It is much more cost effective than planning or executing a Clinical Investigation, so focus on meeting all the SoTA requirements mentioned in the MDCG 2020-13. This will ensure you define the performance and safety range for your device category and alternative therapies. Having this benchmark will ensure you clearly show you meet the GSPR and establish if you have adequate data. It also identifies if data is missing and what PMCF studies you need to undertake.
Partner early with Clinical Evaluation experts to save resources and time so you can focus on other areas. As the Clinical Evaluation is a key workflow that automatically audits your QMS system and highlights areas of concern, it’s the most efficient and cost-effective area to bring in experts. Experienced CER consultants will not only identify problems upstream, but also advise on solutions, best practices deployed by the medical device industry, and efficient workflows to overcome problems later on. Consultancies also come with resources such as systematic review software, access to literature databases, and industry expert reviewers, helping expand your companies’ capabilities cost-effectively.
Consider partnering with a consultancy for the maintenance of your CER. Just because certification is obtained it doesn’t mean the work is over. CLIN-r+ can update documents and create reports as new data arises—and periodically as required—so that you always comply. Investing in ongoing maintenance also helps streamline updates to risk management and SSCPs, and the creation of PSURs. Interested? Get in touch!
