EU MDR 2017/745 Article 61(3a) and Annex XIV Part A Paragraph 1(b) require manufacturers to conduct a methodologically sound and critical assessment of the current scientific literature relating to the safety and performance of a medical device as part of its clinical evaluation.
MEDDEV 2.7/1 Rev. 4 Section 8.2 dictates that the literature search follows a Literature Review Protocol (LRP) that outlines the strategy per Appendix A5. As stated in Appendix A4, the search is expected to be executed in multiple databases, such as PubMed and Embase, after which the retrieved articles are subjected to a selection process based on predefined inclusion/exclusion criteria (Appendix A5.3). This collection process is documented in the associated Literature Review Report (LRR) in accordance with the overall Clinical Evaluation Plan (CEP).
The selected articles are then appraised for suitability (i.e., appropriateness of: Device, Application, Patients, Reporting – DAPR) and data contribution (i.e., source Type, Outcomes, Follow-up, Statistics, Clinical significance – TOFSC) according to IMDRF MDCE WG/N56FINAL:2019, and for level of evidence (i.e., level I to V) in accordance with OCEBM 2011. Ultimately, the findings are summarized in the Clinical Evaluation Report (CER) as part of the collective clinical evidence that supports the safety and performance of the subject device.
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