contact@lne-america.com 1-301-495-0477 lne-america.com LNE/G-MED North America, Inc MEDDEV 2.7.1 Rev 4: Implementing New Requirements for Clinical Evaluation Reports (CER) 1/25/2017 Do not distribute or reproduce without permission 1
contact@lne-america.com 1-301-495-0477 lne-america.com Speaker Anne Le Rouzo • Sr Lead Auditor ISO 13485, ISO 9001, CMDR, MDD, AO regulations, MDD • Non active implantable MD specialist at G-MED NA • Technical Documentation and Design Dossier assessor LNE / G-MED North America, Inc. 1/25/2017 Do not distribute or reproduce without permission 2
contact@lne-america.com 1-301-495-0477 lne-america.com MEDDEV 2.7.1 rev 4 1/25/2017 Do not distribute or reproduce without permission 3
contact@lne-america.com 1-301-495-0477 lne-america.com The new developments of MEDDEV 2.7.1 rev 4 • New Concept introduced: sufficient clinical evidence A Quantity and Quality of the clinical evidence guaranteeing the scientific validity of the conclusions 1/25/2017 Do not distribute or reproduce without permission 4
contact@lne-america.com 1-301-495-0477 lne-america.com The new developments of MEDDEV 2.7.1 rev 4 When is clinical evaluation undertaken? • Clinical evaluation is conducted throughout the life cycle of a medical device, as an ongoing process. 1/25/2017 Do not distribute or reproduce without permission 5
contact@lne-america.com 1-301-495-0477 lne-america.com The new developments of MEDDEV 2.7.1 rev 4 Who conducts the clinical evaluation? The clinical evaluation should be conducted by a suitably qualified individual or a team, taking into consideration: - Definition of the requirements in terms of qualification in line with the device and its clinical performance and risks - Justification of choice of the evaluator(s) - Declaration of interest of each evaluator - Technical and scientific knowledge, - Research methodology, information management, regulatory requirements, and medical writing knowledge - Training and experience 1/25/2017 Do not distribute or reproduce without permission 6
contact@lne-america.com 1-301-495-0477 lne-america.com The new developments of MEDDEV 2.7.1 rev 4 How is the clinical evaluation performed? Definition of the performance data and clinical safety data of the device 5 stages from the scoping and clinical evaluation plan to finalization of the CER 1/25/2017 Do not distribute or reproduce without permission 7
contact@lne-america.com 1-301-495-0477 lne-america.com Stage 4 Stage 0 Clinical Evaluation Scoping & clinical Report evaluation plan Stage 3 Stage 1 Analysis of clinical Identification of data pertinent data Stage 2 Appraisal of pertinent data 1/25/2017 Do not distribute or reproduce without permission 8
contact@lne-america.com 1-301-495-0477 lne-america.com Stage 0: Definition of the scope of the clinical evaluation & Clinical evaluation plan Detailed device description Appendix A3 Identification of the devices (models, sizes, software versions, accessories Concise physical and chemical description (materials, incorporated medicinal substances, tissues, or blood products), Mechanical and physicochemical characteristics; Technologies used Description of innovative aspects of the device Place of the device in regards to available treatment / management/ diagnostic options. Exact description of intended purpose, medical indications 1/25/2017 Do not distribute or reproduce without permission 9
contact@lne-america.com 1-301-495-0477 lne-america.com Stage 0: Definition of the scope of the clinical evaluation & Clinical evaluation plan Setting up the clinical evaluation plan : aspects of the plan depending on the stage in the lifecycle of the product: before CE marking vs. CE marked Device description Information needed for evaluation of equivalence (pre-CE) Risk management Current knowledge/ state of the art in the corresponding medical field Data sources Changes(post-CE) New emerging clinical concerns , PMS aspects (post-CE) 1/25/2017 Do not distribute or reproduce without permission 10
contact@lne-america.com 1-301-495-0477 lne-america.com Stage 1: Identification of the pertinent data Data generated and held by the manufacturer: Pre-market clinical investigations All clinical data generated from RM activities and the PMS programs Pre-clinical data Data from the litterature: Clinical data relevant to the device under evaluation (data relating to either the device itself or to equivalent device) Current knowledge/state of the art 1/25/2017 Do not distribute or reproduce without permission 11
contact@lne-america.com 1-301-495-0477 lne-america.com Stage 2: Appraisal of pertinent data Evaluation of data including scientific validity, relevance and their contribution to the demonstration of conformity – Quality of the methodology & Scientific Validity of the content (9.3.1) – Relevance of the data (9.3.2) – Weight contribution of each data 1/25/2017 Do not distribute or reproduce without permission 12
contact@lne-america.com 1-301-495-0477 lne-america.com Clinical Equivalence Revision 3 • Same intended use and clinical conditions • Same site in the body • Similar population (including age, anatomy, physiology) • Similar relevant critical performance according to the clinical effect expected for a specific intended use Revision 4 • Same clinical conditions and same intended purpose • Same site in the body • Similar population (including age, gender, anatomy, physiology) • Not foreseen to deliver significantly different performances 1/25/2017 Do not distribute or reproduce without permission 13
contact@lne-america.com 1-301-495-0477 lne-america.com Technical Equivalence Revision 3 • Used under similar conditions of use • Have similar specifications and properties (i.e. tensile strength, viscosity, surface characteristics…) • Be of similar design • Use similar deployment methods (if applicable) • Have similar principles of operations Revision 4 • Used under the same conditions of use • Have similar specifications and properties (i.e. tensile strength, viscosity, intensity of energy, wavelength, porosity, surface texture…) • Use similar deployment methods (if applicable) • Have similar principles of operation and critical performance requirements 1/25/2017 Do not distribute or reproduce without permission 14
contact@lne-america.com 1-301-495-0477 lne-america.com Biological Equivalence Revision 3 • Use same materials in contact with the same human tissues or body fluids Revision 4 • Use the same materials or substances in contact with the same human tissues or body fluids Exception: devices in contact with intact skin and minor components of devices. 1/25/2017 Do not distribute or reproduce without permission 15
contact@lne-america.com 1-301-495-0477 lne-america.com Assuming Equivalence Equivalence can only be based on a single device The three characteristics (clinical, technical, biological) must be fulfilled for this same device “Similar” means that no clinically significant differences on the performance and safety of the device would be triggered by the differences between the device currently under assessment and the device presented as being equivalent 1/25/2017 Do not distribute or reproduce without permission 16
contact@lne-america.com 1-301-495-0477 lne-america.com Assuming Equivalence All differences to be identified, fully disclosed, and assessed Comparative engineering drawings or pictures must be presented to be able to compare the design (shape) and the sizes of components in contact with the body The manufacturer must verify whether the presumed equivalent medical device has been manufactured using a special treatment (e.g. surface modification, a process that changes the characteristics of the material); if this is the case, the treatment could cause differences in the technical and biological characteristics; this should be taken into account for the demonstration of equivalence and documented in the CER 1/25/2017 Do not distribute or reproduce without permission 17
contact@lne-america.com 1-301-495-0477 lne-america.com Assuming Equivalence Comparative plans or images should be included to compare the shapes and sizes of the elements in contact with the body The manufacturer should include the non-clinical information (e.g. pre-clinical testing reports) in the technical documentation and summarize the information in the CER (with pointer to relevant sections of the technical documentation) For the evaluation of technical characteristics, devices that achieve the same therapeutic result by a different means cannot be considered equivalent 1/25/2017 Do not distribute or reproduce without permission 18
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