LNE/G-MED North America, Inc

Transcription

1 LNE/G-MED North America, Inc MEDDEV Rev 4: Implementing New Requirements for Clinical Evaluation Reports (CER) Do not distribute or reproduce without permission 1

2 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. Do not distribute or reproduce without permission 2

3 MEDDEV rev 4 Do not distribute or reproduce without permission 3

4 The new developments of MEDDEV rev 4 New Concept introduced: sufficient clinical evidence A Quantity and Quality of the clinical evidence guaranteeing the scientific validity of the conclusions Do not distribute or reproduce without permission 4

5 The new developments of MEDDEV rev 4 When is clinical evaluation undertaken? Clinical evaluation is conducted throughout the life cycle of a medical device, as an ongoing process. Do not distribute or reproduce without permission 5

6 The new developments of MEDDEV 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 Do not distribute or reproduce without permission 6

7 The new developments of MEDDEV 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 Do not distribute or reproduce without permission 7

8 Stage 4 Clinical Evaluation Report Stage 0 Scoping & clinical evaluation plan Stage 3 Analysis of clinical data Stage 1 Identification of pertinent data Stage 2 Appraisal of pertinent data Do not distribute or reproduce without permission 8

9 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 Do not distribute or reproduce without permission 9

10 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) Do not distribute or reproduce without permission 10

11 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 Do not distribute or reproduce without permission 11

12 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 Do not distribute or reproduce without permission 12

13 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 Do not distribute or reproduce without permission 13

14 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 Do not distribute or reproduce without permission 14

15 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. Do not distribute or reproduce without permission 15

16 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 Do not distribute or reproduce without permission 16

17 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 Do not distribute or reproduce without permission 17

18 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 Do not distribute or reproduce without permission 18

19 Assuming Equivalence For the evaluation of the biological characteristics: when a detailed chemical characterization of the materials that are in contact with the body is necessary, then ISO Appendix C can be used to show the toxicological equivalence, but this is just part of the evaluation of the biological criteria; sourcing and manufacturing procedures may adversely affect impurity profiles repetition of testing when production methods or sourcing are changed; it may be necessary to show histopathological studies to demonstrate that the same host response is obtained in vivo for the application and the planned duration of contact; for the tests on animals, the differences between species can reduce the predictive value of the test; the choice of the test and its predictive value must be justified Do not distribute or reproduce without permission 19

20 Assuming Equivalence The only clinical data considered relevant are the data obtained when the equivalent device is a CE marked medical device used for its intended purpose as stated in the IFU. Exceptions may be considered. When the equivalent device is not a CE marked device, information on the regulatory status of the equivalent device and a justification for the use of its data should be included in the clinical evaluation report. The justification should explain if the clinical data are transferable to the European population, and an analysis of possible gaps for good clinical practice (e.g. ISO 14155) and the relevant harmonized standards. Do not distribute or reproduce without permission 20

21 Stage 3: Analysis of the clinical data Analysis the data, whereby conclusions are reached about: Compliance with the essential requirements in terms of performance and safety, including the ratio benefit / risk The contents of the supporting documents Residual risks and uncertainties or Questions unanswered (including rare complications, long-term performance, safety during use in "real life"), if these are acceptable for CE marking, it is necessary that they are followed up by PMS Do not distribute or reproduce without permission 21

22 Stage 4: Clinical Evaluation Report Compilation of relevant clinical data, to establish sufficient clinical evidence necessary to demonstrate compliance. Outlines all stages of the clinical evaluation: Stage 0, scope of he clinical evaluation Stage 1, identification of pertinent data Stage 2, appraisal of pertinent data Stage 3, analysis of the clinical data CER: approved, dated Controlled document (QS) CV and declaration of interests Do not distribute or reproduce without permission 22

23 The new developments of MEDDEV rev 4: Active update of the CER When? Frequency defined and justified, based on criteria (risk, innovation, changes) If new information coming from the PMS, potentially impacting the current evaluation If no new information is coming from the PMS: At least annually if the DM is at risk and / or innovative Every 2 to 5 years, if the DM is not at risk and / or innovative, with justification Do not distribute or reproduce without permission 23

24 The new developments of MEDDEV rev 4: Active update of the CER Why? Ratio benefit/risk profile, side effects and risk mitigation measures: Confirmation of Safety and acceptance per current state of the art Accuracy/relevance of device information materials Accuracy of PMS plan Confirmation of existing claims Justification of new claims Do not distribute or reproduce without permission 24

25 Clinical Evaluation - Sufficient clinical evidence to meet ERs? - Significance of any clinical risks after risk control? Risk Management - Are all clinical risks in RMR? - Risk control identified and verified? - Benefit/Risk ration justified? Post-Market Surveillance - Define the PMS Plan based on the subtle and long term effects to be investigated - Is PMCF study needed as part of the PMS plan? Information Materials - Is the IFUs accurate? - Si all the safety information displayed in IFUs reflected in the RMR? Do not distribute or reproduce without permission 25

26 Thank you! LNE / G-MED North America, Inc Knowles Ave. Suite 306 Kensington, Maryland Office: (301) contact@lne-america.com Do not distribute or reproduce without permission 26