Clinical evaluation report software for meddev compliant. Frequency of updates to the clinical evaluation report cer. Medical device clinical evaluation reports for european ce marking. 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 comprehensive. Manual on borderline and classification in the community regulatory. A practical approach to clinical evaluation that fulfills. Clinical evaluation procedure bundle medical device consultants. Manufacturers of approved medical devices must also regularly update the clinical evaluation report in a predefined modus to include data from actual postapproval experience of the device such as post market v. Course title click on a title to view course description. The redesigned introducer needle of the infusion set part allows the user to choose between manual. Frequently asked questions guidance for industry and food and drug administration staff february 2018.
Understanding the changes to clinical evaluation guideline. 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. Frequently asked questions guidance for industry and food and. Clinical evaluation reports 101 how to create a plan, gather data, and assemble a cer that is compliant with meddev 2. Go through the provided guide to get useful information on the various aspects of making such reports. Clinical evaluation and the clinical evaluation report clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and.
Your cer documents the result of the clinical evaluation of your device. Clinical evaluation of medical devices linkedin slideshare. 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. This is the first post in a 4part series on clinical evaluation reports. Clinical evaluation involves the assessment and analysis of clinical data pertaining.
Every medical device sold into europe, irrespective of its classification, must have an uptodate clinical evaluation report cer as part of its technical file. Any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety andor performance of. Clinical evaluation of medical devices springerlink. Finalize the report after data analysis, the evaluation report should summarize the data analysis. Despite this, there are as always chapters that are worthy of note, some of which are particularly helpful. Requirements of clinical evaluation report for medical.
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. Clinical evaluation and the clinical evaluation report clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. Technical guidance on clinical evaluation of medical devices 1 i. This document promotes a common approach to clinical evaluation for medical devices regulated by directives 90385eec and 9342eec. The regulatory framework for medical devices in the eu clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. The clinical data and the clinical evaluation report pertaining to a medical device. It is important to be wellversed with the various features of the report in order to prevent yourself from leaving out any important part.
The given pdf sample provides an elaborate guide on making a clinical evaluation report. 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. Meddev guidance list download medical device regulation. This term is further explained in ghtf document sg5n1r8. Understanding clinical evaluations, investigations and post. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question. The clinical evaluation report should reflect the current understanding of the benefits and risk of a medical device. 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. The clinical evaluation report cer is the document containing this information to support initial cemarking or ce renewal. 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. If so, you must write and maintain a clinical evaluation report cer as part of your technical file submission.
A cer consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices. Updating a clinical evaluation report cer in clinical, regulatory by dr. Requirements of the medical devices directive to be superseded by the medical devices regulation. The clinical evaluation procedure governs the entire clinical evaluation process from scope definition through clinical evaluation report cer. Clinical evaluation undertaken for the development of a medical device. Although guidance is available on the requirements for clinical evaluation, it is not comprehensive. Ce certification clinical evaluation as per meddev 2. Checklist for your clinical evidence reports tuv sud. 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. Qserve supports medical device manufacturers with their clinical evaluation during distinct phases of product development, underpinned by risk management activities.
The guideline determining the structure and content of the cer is meddev 2. Clinical evaluation is regarded as an ongoing process conducted throughout the life cycle of a medical device. This report should provide strong clinical evidence for conformity assessment so the device can be approved for sale in european markets. 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. Clinical evaluation and postmarket cl inical followup. Chapter 1 deals entirely with clinical trials and having dealt with definition of a medical device then provides an important overview of considerations to be taken into account when organising an appropriate clinical trial. Bfarm clinical trials md performance evaluation studies. Acceptance of clinical data to support medical device. 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. You will understand the detail of what clinical data is. 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. European clinical evaluation reports cer eu meddev 2.
Bsi training clinical evaluation for medical devices. Clinical evaluation report proposed table of contents, examples of contents. It is first performed during the conformity assessment process leading to the marketing of a medical device and then repeated periodically as new clinical safety and. Our services range from regulatory strategy and compliance to clinical evaluation, authorized representation ec rep, and training. A clinical evaluation report cer for medical device is a document which contain the conclusions of the clinical evaluation performed on the medical device based on all relevant clinical data available.
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. Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10. The description should be detailed enough to allow for a valid evaluation of the state of compliance with essential requirements, the retrieval of meaningful literature data and, if applicable, the assessment of equivalence to other devices described in the scientific literature. Clinical evaluation reports from the medical writers. For more than 20 years, cepartner4u has been a valued partner of hundreds of organizations worldwide. Clinical evaluation guidance for industry and food and drug administration staff document issued on december 8, 2017. Assessment of clinical evaluation reports for medical devices. This webinarcourse provides a guideline on how to prepare a clinical evaluation for a medical device, considering the applicable laws and. Clinical evaluation clinical data the clinical data and clinical evaluation report pertaining to a device sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefits when used as intended by the manufacturer. Clinical evaluation report sample contents i3cglobal. It is first performed during the conformity assessment process leading to the. Understanding clinical evaluations, investigations and. Clinical evaluation report dr hos muscle therapy unit modulated tens device prepared by stuart m.
Mcgill, phd, professor, and jordan cannon department of kinesiology, faculty of applied health sciences, university of waterloo june 2014. Pdf directive 200747ec1 amends the earlier medical device and active implantable. The clinical data and the clinical evaluation report. If you plan to sell your medical devices in europe, you must produce and maintain a clinical evaluation report cer that complies with meddev 2. 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. The new requirement a 2007 amendment to the medical devices directive mdd 9342eec will come into force in march 2010. Pdf the european medical device regulation 2017745eu. Regulators around the world are increasing expectations for clinical evaluation of medical devices for all devices with tougher requirements for higher risk. Tuv suds clinical center of excellence has compiled a checklist to support medical device manufacturers in making complete and correct submissions of clinical evidence. Pdf clinical evaluations clinical investigations under the amended. Acceptance of clinical data to support medical device applications and submissions. Technical guidance on clinical evaluation of medical devices.
The cer and the clinical data are used together to prove the conformity of the medical device to the general safety and performance requirements. Highly praised in its first edition, clinical evaluation of medical devices. Cromsource is an expert partner for clinical data management, statistics and medical writing projects. The clinical evaluation report must include all clinical evidence required to support medical device conformity assessments in the eu. The results of this process are documented in a clinical evaluation report. Does your medical device cer meet eu mdr requirements.
Benefitrisk evaluation in a clinical study means comprehensive evaluation of all events with relevance for the safe use of the medical device, irrespective of relation to the investigational device, the medical procedure involved or any other factor and regardless of whether they are anticipated or not. It documents evidence supporting a medical device licensing application and, after a successful application, is. Ghtf sg5 clinical evaluation international medical device. Content download oriel stat a matrix medical device cers. 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.
This twoday introductory course will cover all aspects of clinical evaluation in line with the european medical device regulation mdr and applicable guidance documents. Any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety andor performance of a medical device. Article 60c of the mdr states that, for all devices in classes iia and above, manufacturers should create a periodic safety update report psur that must be maintained throughout the. Technical guidance on clinical evaluation of medical devices 1. Such common specifications should be developed specifically for a group of products without an intended medical pur pose and should not be used for confor mity assessment of the analogous devices with a medical pur pose. Clinical evaluation needed to demonstrate the safety and performance of manufacturers devices. A practical approach to clinical evaluation that fulfills the. 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.813 459 439 610 109 343 1031 127 704 211 505 304 466 873 1349 382 679 1048 1297 1337 1491 318 585 1304 601 122 938 227 1123 1288 1406 1195 234 437 379 358 479 1326 165 283 1499 1107 837 289 98 1413 990 1278