Examine best practices to combine pmcf data into the clinical evaluation. Clinical evaluation of medical device commented interactive. Clinical evaluation latest development in expectations. Listed below are our base, design, and manufacturing systems along with a content comparison table to help y. Current medical device regulations in both europe and china require that clinical evaluation reports cers be based on guidelines on medical devices meddev, cfda technical guidelines for the clinical evaluation of medical device in addition to clinical evaluation requirements contained in mdr. The newest revision has defined, clarified and tightened guidance on clinical evidence requirements for unapproved technologies as well as products that have been on the market for an extended period. Acceptance of clinical data to support medical device applications and submissions. Frequently asked questions guidance for industry and food and drug administration staff february 2018. This webinar is led by sam martin, chair of day 2 of the medical device school. This webinar course provides a guideline on how to prepare a clinical evaluation for a medical device, considering the applicable laws and standard, providing example and also a guideline.
Establishing stateoftheart compliance for medical devices. He now created the consulting firm easy medical device gmbh and. Food and drug administrations regulatory process for the marketing of medical devices. The original edition of this text, clinical evaluation of medical devices. Clinical evaluation of medical devices springerlink. In neracs experience, notified bodies have shown an increased emphasis on the clinical evaluation reports which support the safety and performance of approved devices.
You will understand the detail of what clinical data is needed, how to collect it, analyse it and produce a cer that is acceptable to the regulatory authorities and notified bodies. Clinical evaluation and clinical investigations vii. As such it is particularly useful, covering many of the problems anyone involved in the development of medical devices will encounter, for example, the use of randomised controlled trials and how difficult it is to apply them to devices. Clinical evaluation guidance for industry and food and drug administration staff document issued on december 8, 2017. Fda guidance on conduct of clinical trials of medical. Clinical evaluation is a methodologically sound ongoing procedure to collect and analyse clinical data pertaining to a medical device and to assess whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturers. In an effort to increase the safety and reliability of medical devices. In the european union medical device regulation there are 3 categories. Principles and case studies, second edition, provides a goldstandard resource for clinical professionals and regulatory specialists working at the forefront of new therapeutics, diagnostics, and medical device development and marketing today.
Get full 1 hour windows media video file and powerpoint presentations for immediate download here. The programme will provide you with the tools and skills you will need to produce a highquality clinical evaluation report cer for all your medical devices. The clinical evaluation of medical devices is the assessment procedure conducted by registration applicants to validate whether the application requirements or intended use of the device s under application can be achieved based on clinical literatures, clinical experience. The bottom line of the amendment is that every medical device sold in europe, regardless of its classification, must have a clinical evaluation ce report in its technical file. Clinical evaluation guidance for industry and food and drug administration staff december 2017. As per chapter vi, article 49, clinical evaluation needed to demonstrate the safety and performance of the devices. Tuv sud can also perform voluntary preassessments of manufacturers clinical evaluation reports. Meeting the eus clinical evaluation requirements for medical devices the clinical evaluation of a medical device is intended to critically evaluate the clinical benefits of a given device against the potential risks it poses to patients. Dont forget to download the presentation that robert prepared about.
Japan medical device regulatory updates and recent revisions. Clinical evaluation of medical devices principles and. June 22nd, 2015 the regulatory changes occurring in the eu have resulted in an increased scrutiny for many medical device manufacturers. Medical devices isotc 194, biological and clinical evaluation of medical devices this iso technical committee standardizes biological test methods for the evaluation of medical and dental materials and devices prior to their release for commercial use. Bsi training clinical evaluation for medical devices.
Classification medical device in eu medical device. Preparing for your clinical evaluation report q1 productions. The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturers postmarket surveillance plan for highrisk medical devices, manufacturers should summarize the main safety and performance aspects. Acceptance of clinical data to support medical device. Clinical evaluation l performance evaluation of medical. This twoday introductory course will cover all aspects of clinical evaluation in line with the european medical device regulation mdr and applicable guidance documents.
Clinical evaluation of antiepileptic drugs adults and. As medical device manufacturers navigate the changing industry landscape throughout the implementation of the european medical device regulation, one of the most pressing requirements facing clinical research executives is the enhancement of postmarket clinical followup, surveillance, and reporting strategies. Contact fda follow fda on facebook follow fda on twitter view fda videos on youtube subscribe to fda rss feeds fda homepage contact number 1888infofda 18884636332. Metoo medical devices clinical trial data not required and compliant with approval standards this category is for medical devices regarded as the metoo type that 1 have an applicable approval standard and meet the. Clinical data for low risk medical devices with robert. Although guidance is available on the requirements for clinical evaluation, it is not comprehensive. Ce certification clinical evaluation as per meddev 2. The rising demand for early and accurate disease diagnosis and the growing possibilities in personalized medicine are driving the demand for invitro diagnostic medical devices ivds.
Technical guidance on clinical evaluation of medical devices 1. Such reports are important for conveying information regarding how fit or unfit a person is for a given job or task. Course title click on a title to view course description. How to collect clinical data for medical devices with. Highly praised in its first edition, clinical evaluation of medical devices. This documentation shall be included andor fully referenced in the technical documentation of the device. The requirements for clinical evaluation apply to all classes of medical devices class i to class iii the evaluation should be appropriate to the device under evaluation, its specific properties, and its intended purpose two common scenarios with limited clinical data well established devices accessories. This webinarcourse provides a guideline on how to prepare a clinical evaluation for a medical device, considering the applicable laws and standard, providing example and. With the new medical device regulation eu mdr 2017745, you will maybe. Clinical evaluation of medical devices linkedin slideshare. Regulatory strategies for eu mdr and eu ivdr implementation. Understanding clinical evaluations, investigations and.
Regulators around the world are increasing expectations for clinical evaluation of medical devices for all devices with tougher requirements for higher risk. Evaluation of medical devices or products is required to determine which directive is applicable for the product so that the ce certification process can be determined. Authoritative and highly practical, clinical evaluation of medical devices. Cfda technical guideline on medical devices clinical evaluation. As part of the conformity assessment route and risk management plans all medical devices require an evaluation of the existing clinical data on similar devices this then makes up a part of the technical documentation. Checklist for your clinical evidence reports tuv sud.
The clinical evaluation procedure bundle includes procedures for clinical evaluation, clinical investigation, post market surveillance and pmcf, and ce marking requirements. Medical devices directive, 9342eec annex i, essential requirements 6a annex x, clinical evaluation active implantable medical devices directive, 90385eec annex 1, essential requirements 5a mandatory clinical evaluation er 5a6a. Where are regulatory requirements for clinical evaluation specified. The current medical device directives place responsibility on the manufacturer to update and maintain clinical evidence for their devices. Qserve group clinical evaluation of medical devices page 4 1. The regulatory framework for medical devices in the eu clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. Oct 14, 2014 a clinical evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. To find out more about this course please visit our course website here. How to perform literature search for your cer eu mdr. The new requirement a 2007 amendment to the medical devices directive mdd 9342eec will come into force in march 2010. David also shared with us a presentation that you can download from the. Bsis clinical evaluation for medical devices one day course is designed to support manufacturers by confirming the information necessary to demonstrate clinical safety and performance of their product in accordance with the requirements of the european medical devices directive. Principles and case studies, provided the first overview of key pr ciples and approaches to medical device clinical trials, illustrated with a series of detailed, realworld case studies. Regulators worldwide came together at the th meeting of the international medical device regulators forum imdrf in shanghai, where they adopted a new work item the first to have been proposed by china to conduct research on clinical evaluations of medical devices on a global scale.
Assessment of clinical evaluation reports for medical devices. Clinical evaluation of medical device commented interactive presentation webinar 125. The clinical evaluation and its documentation must be actively updated with data obtained from the postmarket surveillance. In 2003 he started at notified body kema quality b. Clinical evaluation latest development in expectations eu. Every medical device sold into europe, irrespective of its classification, must have an uptodate clinical evaluation report cer as part of its technical file. Clinical evidence for ivd medical devices key definitions and concepts study group 5 final document ghtfsg5n6. Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers ix. Mar 30, 2015 clinical evaluation of medical devices. Clinical evaluation of medical devices this masterclass is also module 15 of the msc regulatory affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.
You will understand the detail of what clinical data is needed. Understanding the changes to clinical evaluation guideline. Part 2 of the book deals with a series of clinical examples. A practical approach to clinical evaluation that fulfills. A guide for manufacturers and notified bodies the present guidelines are part of a set of guidelines relating to questions of application of eudirectives on medical devices. A practical approach to clinical evaluation that fulfills the. Vincent legay september 30, 2014 clinical evaluation is the assessment and analysis of clinical data needed to verify the clinical safety and performance of your medical device.
To give detailed guidance on when clinical data may be needed for an original samd and for a modification to a samd based on the risk classification for samd samd n12 adopted by. Cromsource is an expert partner for clinical data management, statistics and medical writing projects. Assessing and adopting new medical devices for obstetric and. Understanding clinical evaluations, investigations and post. Display event clinical evaluation of medical devices. Clinical evidence itself is defined as clinical data and its evaluation pertaining to a medical device and is used to support the marketing of a device. Purpose the clinical evaluation of medical devices is the assessment procedure conducted by registration applicants to validate whether the application requirements or intended use of the target medical devices can be achieved based on a comprehensive. This session aims to cover the general principles of clinical evaluation of medical devices according to the eu mdr 2017745, the process to. By marcelo trevino, president, global regulatory affairs and quality systems, tregmedical.
It is undertaken with an initial conformity assessment that is used to obtain the marketing license or ce mark of the device in the eu, and then repeated periodically as new. Technical guidance on clinical evaluation of medical devices 1 i. Future of clinical data and medical device regulation 2017745. Ghtf sg5 clinical evidence for ivd medical devices november. Technical guidance on clinical evaluation of medical devices. Medical device regulation training within less than 10 minutes youll. As such, clinical evaluations are an essential element of the risk management process applicable to medical. Demonstration of equivalence class i, iia, iib medical devices clinical data relating to another device may be relevant where equivalence is demonstrated same intended purpose and when the technical and biological characteristics of the devices and the medical procedures applied are similar to such an extent that there would be not a clinically significant.
Imdrf work on device clinical evaluations unanimously. Further it must be determined which product category is applicable for the medical devise product concerned. This guidance represents the food and drug administrations fdas. The clinical evaluation of medical devices is the assessment procedure conducted by registration applicants to validate whether the application requirements or intended use of the devices under application can be achieved based on clinical literatures, clinical experience.
This document promotes a common approach to clinical evaluation for medical devices regulated. Clinical evaluation of medical devices according to eu. Clinical evaluation for medical devices course description bsis clinical evaluation for medical devices one day course is designed to support manufacturers by confirming the information necessary to demonstrate clinical safety and performance of their product in accordance with the requirements of the european medical devices directive. Jul 27, 2017 7272017 31 summary scope clinical background, current knowledge, state of the art device under evaluation type of evaluation demonstration of equivalence clinical data generated by manufacturer clinical data from literature summary and appraisal of clinical data analysis of the clinical data. A guide for manufacturers and notified bodies under directives 9342eec and 90385eec note the present guidelines are part of a set of guidelines relating to questions of application of ecdirectives on medical devices. This term is sometimes referred to as clinical validity but clinical performance is the recommended term. This video covers regulation eu 2017745 with a special focus on the collection, generation and evaluation of clinical data for medical devices. Clinical evaluation of medical devices qserve group. Medical device qms configurations that allow our customers to select the best possible solution for gaining iso 485. A clinical evaluation is a required element of the conformity assessment process in the european union eu for medical devices, and serves to substantiate manufacturers claims regarding the safety, performance and benefitrisk ratio of medical devices. A guide to european medical device trials and bs en iso 14155. On may 19 th, 2015, china food and drug administrative cfda released the technical guideline on medical devices clinical evaluation hereinafter referred as guideline, which aimed to provide the reference and instruction for the registration applicant to conduct clinical evaluation, as well as provide the technical principle for cfda management department to examine the clinical evaluation.
Discover how to incorporate biological evaluations into the clinical evaluation. Principles and case studies, second edition has been expanded and updated to include the many innovations and clinical research methods that have developed since the first edition, as well as current information on the regulatory, legal, and reimbursement environment for medical devices. Evaluation of sexspecific data in medical device clinical. Purpose the clinical evaluation of medical devices is the assessment procedure conducted by registration applicants to validate whether the application requirements or intended use of the target medical device s can be achieved based on a. Postmarket surveillance, vigilance and market surveillance viii. In the past 15 years the biometrics group within cromsource has conducted hundreds of important projects either as part of fullservice agreements or as standalone assignments. Tuv suds clinical center of excellence has compiled a checklist to support medical device manufacturers in making complete and correct submissions of clinical evidence. This presentation provides an overview of the new requirements of medical device regulation 2017745 as well as of the meddev 2. I will also provide you with a free form to download so you can be. Updating a clinical evaluation report cer in clinical, regulatory by dr. A clinical evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. Scoping the clinical evaluation the specific regulatory requirements to be addressed as well as the relevant clinical research questions need to be identified in a clinical evaluation plan or strategy. Guidance for industry and food and drug administration staff. No matter whatever the class of the device in short, the meddev 2.