Review Article - (2022) Volume 6, Issue 4

Tips for writing high quality clinical evaluation reports (CERs)

Clinical Evaluation Reports (CERs) are required for all medical devices where manufacturers are seeking approvals or renewals for CE marking. European Union (EU) Medical Device Regulation (MDR) (EU2017/745) imposes strict requirements regarding the contents of CERs. Format, contents, process and details expected in CERs are described in MEDDEV 2.7/1 Rev 4. As per this format, CER for a medical device is an integrated report including data from various sources like clinical investigations, risk assessment, post marketing surveillance, post marketing clinical follow-up plan, literature searching and regulatory databases. Thus, in order to prepare high quality CERs that adequately represent a medical device’s benefit risk profile, CERs should be prepared by a strong team who not only understand about the medical device, but also have good understanding of the clinical condition and potential patients/ users, and ability to review and appraise the data collected from various sources so that CERs correctly capture the benefits and risk associated with the medical device with due considerations to the current state of the art technologies and therapeutic options available for the patients/ users.

Author(s): Deepa Arora

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