The first blog post of this series, State of the Art (SOTA) Part I: What is a State of the Art Evaluation? discussed the use and definition of state of the art as used in the 4th revision of the European Commission’s Guidelines on Medical Devices, "MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC".
In part two of the RQM+ SOTA series, our experts continue the conversation by digging further into Clinical Evaluation Reports and Clinical Literature Review Objectives to help medical device manufacturers get (or keep) your medical device on the market in the European Union (EU) understand the specific requirements mentioned in the guidance.
Safety and Performance versus the State of the Art:
The clinical literature evaluation contains two literature evaluations: “Safety & Performance” and “State of the Art”. These two literature evaluations have different objectives and, therefore, usually require separate searches with different inclusion/exclusion criteria.Inclusive to both Safety & Performance and State of the Art literature evaluations:
- Systematic and unbiased: The purpose is to systematically identify relevant clinical literature, both favorable or unfavorable.
Search protocol: The search terms, inclusion criteria, exclusion criteria, appraisal criteria, and methodology need to be defined before execution to maintain objectivity.
Search adequacy: Are the search terms comprehensive? Are the databases used appropriate and adequate?
Appraisal: The suitability and contribution of each included article should be appraised (MedDev 2.7/1 rev4 Section 9)
Literature report: Documents details of the search that enables the search to be reproduced and understood by a third party and provides a detailed analysis of the literature along with scientifically valid conclusions.
Safety & Performance-specific evaluation:
The focus is only on the safety and performance of the device under evaluation or an equivalent device. Literature in this section summarizes the safety and performance outcomes reported in the literature specific to the device under evaluation or equivalent device.
Items to include or evaluate:
- The literature on the device under evaluation or equivalent device
- Detailed performance outcomes of the device under evaluation
- Detailed safety outcomes of the device
- Search terms encompass: Name of device under evaluation, previous or alternative names, and company name linked with medical condition:
- Dates covered: The evaluated literature needs to be comprehensive and date back to the device’s initial CE mark.
State of the Art-specific evaluation:
The focus is on the treatment of the medical condition. The focus encompasses devices similar to the device under evaluation (including the device under evaluation itself) and alternative treatments. Literature in this section should enable a comparison between the safety and performance of the device under evaluation to similar devices or alternative devices or treatments.
Items to include or evaluate:
- Overview of the medical condition being treated, including things such as natural course and consequences, clinical forms, patient populations, and risk factors for disease development.
- Description of similar devices and alternative devices or treatments along with what is considered standard of care. The description should include a summary of safety and performance outcomes including a discussion of proposed benefits/limitations of the device under evaluation, similar devices, and alternative treatments.
- Summary of clinical practice guidelines and discussion of existing standards for medical condition, device, similar devices, and alternative treatments.
- Search terms encompass: Keywords from indications, similar device names, alternative devices or treatment names, keywords pertaining to the medical condition, and type of device.
- Dates covered: Typically covers the last 5 to 10 years depending on the extent of studies available and type of device.
As always, RQM+ experts are ready to answer your questions and work through your challenges with our structured CER/PER business unit and dedicated team, including program management and SMEs. Book a consultation with our experts today.
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1) European Commission. Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42 and 90/385. Last updated 22/06/2020. Accessed 22/06/2020. https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/
2) European Commission. MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies. Last updated 24/04/2020. Accessed 22/06/2020. https://ec.europa.eu/docsroom/documents/40904
3) European Commission. MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies. Last updated 24/04/2020. Accessed 22/06/2020. https://ec.europa.eu/docsroom/documents/40903