The European Medical Device Regulation (EU MDR) introduces significant changes across the technical documentation of medical devices mandating manufacturers to provide sufficient evidence of compliance with the applicable General Safety and Performance Requirements.
To meet the increased requirements for clinical evidence, manufacturers must generate and collect risk-based post-market surveillance data throughout the expected lifetime of a medical device and critically appraise them in combination with literature data for the intended medical field and respective indications, while taking into account design specifications, usability, and verification and validation reports.
Although the first step of the transition to the MDR must always be a holistic gap analysis and the development of a concrete plan for compliance of the Quality Management System, it is often the preparation of Clinical Evaluation Reports (CERs) that hampers remediation activities due to systemic gaps and lack of appropriate technical documentation.
Within this context, Dr Vasiliki Valla, Kyriaki Antonopoulou, Dr Amy Lewis, Dr Bassil Akra and Dr Efstathios Vassiliadis evaluated a total of 114 CER projects for medical devices of various types and of all classes to identify, classify and discuss the major documentation gaps and their resulting regulatory impact.
This article has been published in the November 2021 issue of the Journal of Medical Device Regulation.
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