The Clinical/Performance Evaluation Report (CER/PER) holds pivotal importance within the context of EU MDR/IVDR applications, determining manufacturers' eligibility for obtaining the CE mark. Embedded within the Clinical/Performance Evaluation procedure, the systematic literature review (SLR) process emerges as a vital workflow demanding proficiency. Crafting an SLR Standard Operating Procedure (SOP) that aligns with MEDDEV 2.7.1rev4 and the MDCG guidelines could potentially revolutionize not only your CE mark submission but also the post-market trajectory of your medical device. Conversely, if this workflow falls short of compliance with the guidelines, rectifying it might consume considerable time and jeopardize your device's CE mark.

Our forthcoming webinar delves into the most prevalent findings identified by auditors in relation to the SLR process and its interconnectedness with the Clinical Evaluation segment of your technical dossier. We thoroughly explore strategies to shield your CER from potential repercussions arising from the SLR process. Furthermore, we elucidate the optimal resources for conducting an SLR and furnish you with a comprehensive checklist encompassing the essential components that should be integral to your SLR process's quality assurance workflow.

Key Takeaways:

  • A manufacturer's SLR SOP significantly influences EU MDR assessment success

  • Clinical Evaluations pose technical challenges requiring proper infrastructure and clinical affairs resources (e.g., skilled SLR reviewers, access to medical databases) for MEDDEV 2.7.1rev4 compliance

  • Non-conformance findings often arise from the CER, with the SLR process being a potential culprit, requiring costly and time-consuming corrections

  • Manufacturers should be aware that NBs allow only 3 rounds of review. Excessive non-conformances lead to halted reviews and NCR feedback highlighting gaps for resolution

  • CER assessment follows QMS review. Weak CER or flawed SLR increases findings, risking unsuccessful applications

  • Success hinges on compliant SLR SOP (refer to checklist) and sufficient resources for proper SLR execution

  • Part of the Cracking the Code: Demystifying EU MDR and IVDR Compliance webinar series:

  • Webinar One: Demystifying EU MDR: Navigating Compliance Challenges and Achieving CE Certification

  • Webinar Two: Navigating the IVDR Maze: From CE Certification to IVD Device Registration
  • When
    Wednesday, September 13, 2023 · 3:00 p.m. London (GMT +1:00)
    Jacqueline van Druten
    Clinical & Regulatory Affairs Director, CLIN-r+
    Jacqueline van Druten (MICR.CIM.RD) is a medical professional with extensive experience in Clinical Regulatory Affairs. With a passion for MedTech, Jacqueline has been a driving force building CLIN-r+ EU MDR submissions automation and fast track Clinical Development Strategy workflow for EU MDR submissions for manufacturers. Her expertise is backed by 20 years of hands-on experience in healthcare research and medical innovations.

    As a contributor and lead in Research, Regulatory and Clinical Affairs at various multi-national medical organizations, Jacqueline has been instrumental in supporting the translation of medical interventions into measurable patient outcome data. Enabling healthcare innovations obtain regulatory clearance, market access and product differentiation to meet their investment promise. Her career and team contributions have a proven track record of success in obtaining and maintaining EU MDR CE marking in various product classes, demonstrating their deep understanding of obtaining a successful innovation profile for commercial, clinical benefit and regulatory compliance.
    Danielle Thomas
    Customer consultant Embase, PharmaPendium, Corporate, North America
    Danielle has a PhD in Pharmaceutical Sciences and Molecular Biology & Biochemistry. After years of research, working in drug discovery and delivery of chemotherapeutics, Danielle joined Elsevier August of 2021. Currently, Danielle is the Customer Consultant of Life Sciences products, including Embase, and PharmaPendium covering North America. As a Customer Consultant, she is dedicated to assisting scientists and researchers streamline their workflows by providing customized training sessions. customized training sessions.
    Maria Shkrob
    Consultant Life Sciences
    Maria holds a PhD in molecular biology and contributed three years to biotech company Evrogen before venturing into the bioinformatics field at Ariadne Genomics and then Elsevier. With over a decade of bioinformatics experience, she specializes in designing software and databases, as well as addressing research challenges for pharma and biotech customers.
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