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BioReg Services specializes in systematic literature reviews in compliance with the MDR Regulation (EU) 2017/745, IVDR Regulation (EU) 2017/746 and MEDDEV 2.7/1 rev.4 (2016) guidance.
Our team can design a comprehensive literature search protocol with complete documentation of the literature screening and data extraction process. We can obtain clinical evidence for the literature review for your new medical device or update the literature review of a CE-marked or legacy device to create an MDR-compliant document.
The literature review is part of the Clinical Evaluation Report and should be based on a search protocol that documents the search planning before execution.
For the literature search methods and strategy review, MEDDEV 2.7/1 revision 4, section A5 and MDCG 2020-13, Section D. The literature data should be retrieved from at least two databases. For e.g., you can use PubMed & Cochrane Library database. The literature search should clearly distinguish between two types of data: the device under Evaluation (or its equivalent device) and the State-of-Art (SoA). The literature search should be documented in sufficient detail so that the methods can be appraised critically, the results verified, and the search reproduced if required.
See our 3-part series blog about the Medical Device Literature Review Part 1, Part 2 and Part 3.
For more information, please contact the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.