Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance
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This document provides an overview of a clinical evaluation report (CER) that decodes the step-wise approach for compliance. It discusses key regulatory requirements for CERs including author and evaluator qualifications, specific objectives, data update frequency, use of peer-reviewed literature, demonstration of equivalence, access to equivalent device data, risk-benefit analysis, and post-market data links. The document also characterizes CERs as live documents that require regular review and updates incorporating post-market surveillance activities. Finally, it invites the reader to access an online session for more information on authoring a compliant CER.
Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance
- 1. Clinical Evaluation Report (CER)Decode the Step-wise Approach for Compliance Date 11th December 2018
- 2. Regulatory : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORT | INTELLIGENCE | LABELING | SOFTWARE 2www.freyrsolutions.com | sales@freyrsolutions.com | CER- Industry Reception in last 2 years 04 Clinical Data, Evaluation and Evidence - Overview 05 Agenda PMS Data – Key Input for CER 06 Clinical Evaluation - - Key component for Clinical EvidenceE 07 Key High Lights of MEDDEV 2.7/1 REV 4 08 Clinical Evaluation Report- Key Characteristics 09 Focus points for a “compliant CER” 12 Stage wise approach for CER Authoring 13 Key Impact Elements for CER Projects 14 Requirement of Enablers in CER Projects 20 Next steps 20 Current Challenges 14
- 3. Regulatory : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORT | INTELLIGENCE | LABELING | SOFTWARE 3www.freyrsolutions.com | sales@freyrsolutions.com | Regulatory Requirements for CER – Key highlights Qualification of report authors and evaluators Specific and measurable objectives for a CER Frequency of updates to a CER Scientific validity of the data ( peer- reviewed literature) More specific demonstration of equivalence Access to data for equivalent devices Detailed Risk-Benefit Analysis Link between PMS & PMCF Requirements for Clinical Investigation
- 4. Regulatory : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORT | INTELLIGENCE | LABELING | SOFTWARE 4www.freyrsolutions.com | sales@freyrsolutions.com | Clinical Evaluation Report – Key characteristics Clinical evaluation is the assessment and analysis of clinical data needed to verify the clinical safety and performance of your medical device. Live Document Stand Alone Document Require regular reviews and updates through out the device life cycle Require updates from post-market surveillance activities
- 5. Regulatory : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORT | INTELLIGENCE | LABELING | SOFTWARE 5www.freyrsolutions.com | sales@freyrsolutions.com | Questions Would you like to decode the step-wise approach for CER? We Appreciate Your Interest to Know More on ”Clinical Evaluation Report (CER)”. To Access the Entire Session, Click Here. https://www.freyrsolutions.com/webinars/clinical- evaluation-report-cer-decode-the-step-wise- approach-for-compliance
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