Greater emphasis is being placed on clinical data and the clinical evaluation process under Regulation (EU) 2017/745 (MDR) compared to under the Medical Device Directive 93/42/EEC (MDD). Clinical data is defined in the MDR as “information concerning safety or performance that is generated from the use of a device”, with identified relevant sources of clinical data including “clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated” and “reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated”.
Within the context of clinical evaluation of a device, a systematic scientific literature review process must be performed to identify and evaluate clinical data relevant to the subject device, as well as the generally acknowledged state of the art.
The MDCG 2020-13 guidance presents a Clinical evaluation assessment report (CEAR) template to be used by the Notified Bodies. This CEAR template includes detailed questions around the literature review components for both state of the art and clinical data for the subject (and equivalent) devices. It is clear that the Notified Bodies must see an appropriate, robust, transparent, and adequately documented literature review process. Many manufacturers struggle with literature review, in particular the state of the art.
The literature review process should be guided by MEDDEV 2.7/1 Revision 4; however, the MEDDEV was not written to meet MDR requirements. Furthermore, the best approach is not a one-size-fits-all solution across all devices and reports.
Working with over 100 medical device manufacturers over the past 10 years, Nerac has refined our literature review process across over 350 EU clinical literature evaluations under both the MDD and the MDR.
The flexible, customizable Nerac literature review process efficiently addresses common manufacturer pain points such as: development of appropriate, high quality search strategies; adequate evaluation of state of the art as defined in MDCG 2020-6, IMDRF/GRRP WG/N47, and ISO 14971, and as described in MEDDEV Revision 4; use of state of the art literature to inform clinical outcome parameters and acceptance criteria; and development of an appropriate overall literature review strategy for devices with either very little or extremely high volumes of published clinical literature.
A simplified overview of the Nerac literature review process for EU MDR compliant clinical literature evaluations is demonstrated in the figure below. The Nerac literature review process is informed by MEDDEV Revision 4, MDCG guidance documents, IMDRF MDCE WG/N56FINAL:2019, and manufacturer feedback and Notified Body audit findings.
Look out for Nerac’s upcoming articles on leveraging literature reviews across various regulatory deliverables and markets!
How Can Nerac Help?
Nerac’s Medical Device team has extensive experience assisting manufacturers in developing MDR 2017/745 compliant Clinical Evaluation Reports. Our analysts are experts in identifying and analyzing clinical data from available literature as it relates to state of the art and safety and performance for medical devices.
Erica works with medical device clients to conduct research of the clinical literature, prepare Clinical Evaluation Reports, and conduct focused research to address clients’ critical questions relating to the medical device industry across many device and therapeutic areas.
Ph.D. Materials Science and Engineering, University of Connecticut
M.S. Biomedical Engineering, University of Connecticut
Regulatory Affairs Professionals Society
Society for Biomaterials
Materials Research Society
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This article outlines the importance of systematic clinical literatures for achieving and maintaining regulatory compliance, most notably in the EU but also in other markets, which may have differing literature review requirements.
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