2022年10月4日 · According to the Regulation (EU) 2017/745, Article 61 and ANNEX XIV, the evaluation of the clinical performance and safety as well as the clinical benefit must be based on clinical data and is required for all medical device classes.

A clinical evaluation assessment report (CEAR) is a report used by the notified body to clearly document the conclusions of its assessment of the clinical evidence presented by the manufacturer in the clinical evaluation report (CER) and the related clinical evaluation that was conducted – a core requirement of the Medical Device Regulation (EU)...

The CEAR template represents minimum content for NB review process – each NB needs standard operating procedures (SOP) for their CEAR work! a clinical benefit for patients, when used as intended...” Clinical Safety – NB must answer several questions: Does CER “adequately” address safety including “residual risks and undesirable side effects”?

evaluation of acceptability of the benefit-risk ratio. Based on the findings in the clinical data review as well as in the risk analysis, it can be inferred that the probability of a patient experiencing a substantial benefit when using the [device name] outweighs the probability of suffering harm due to a residual risk of the device ...

A clinical evaluation is performed through the objective assessment of all clinical evidence relating to the subject medical device, whether favourable or unfavourable, in order to determine …

2020年7月17日 · Guidance - Clinical evaluation assessment report template; News announcement; 17 July 2020; Directorate-General for Health and Food Safety; 1 min read; Guidance - Clinical evaluation assessment report template. 1 DECEMBER 2021; mdcg_clinical_evaluationtemplate_en.pdf. English (262.13 KB - PDF) Download. Details. …

2022年7月11日 · Clinical Evaluation Report Template The MDCG issued MDCG 2020 -13 guidance for notified bodies (NB) specifying a template to be used during auditing the clinical evaluation (CER) of manufacturers. Although the guidance document is intended for the NB’s, manufacturers can benefit from it during preparation of the clinical evaluation report ...

2023年11月1日 · This template is the bare minimum to ensure that your Clinical Evaluation Report is compliant with the requirements for the initial CE-marking and follows the key points the notified bodies in the EU will assess your Clinical Evaluation Report for.

2020年5月14日 · Girish Hirpara, regulatory consultant on Kolabtree, provides a clinical evaluation report sample for medical devices to use as a template for MDR compliance. The clinical evaluation report (CER) is a mandatory document for medical devices that are …

This Clinical Evaluation Report (CER) Template is specifically designed to be used in conjunction with the Clinical Evaluation Plan (CEP) Template. The sections of this CER Template include all the fundamental components of an EU MDR 2017/745-compliant CER.