Clinical literature reviews are critical components to achieving MDR compliance. Article 61 of the MDR states that a clinical evaluation should be based on “(a) a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device…; (b) a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and (c) a consideration of currently available alternative treatment options for that purpose, if any”. Thus, to generate a high quality and compliant Clinical Evaluation Report (CER) under the MDR, systematic literature reviews should be performed for literature pertaining to subject device safety and performance, state of the art, and similar device safety and performance.
Specified similar device literature may be used to inform the state of the art analysis and determine outcome measures for the Clinical Evaluation Plan (CEP). Additionally, it is an MDR requirement that the analysis of equivalent and similar device data be incorporated into post-market clinical follow-up reports.
In fact, in addition to the CER, under MDR expectations, the collection of relevant literature data pertaining to the subject device also contributes to post-market surveillance (PMS) /post-market clinical follow-up (PMCF) activities.
For clinical evaluation, the literature review provides information regarding state of the art and reports on device-specific evidence of safety and performance. Literature reviews in support of PMS activities identify adverse events or risk associated with the subject device, and literature reviews in support of PMCF provide ongoing support for the subject device’s safety and performance profile.
Therefore, review of scientific literature may be needed for several EU MDR deliverables:
In all cases, an MDR compliant literature review plan is necessary (see Nerac’s recent article on the EU MDR Literature Review Process).
Without a well-constructed plan, the need to review scientific literature to inform multiple deliverables can be burdensome. In addition to introducing inefficiencies to your process, there is the risk of introducing inconsistencies across documents. A well-constructed plan may allow manufacturers to leverage a single literature search across multiple deliverables, ensuring high quality output and saving time and money.