A clinical evaluation report should be prepared after completion of the clinical evaluation see annex 8 for the format, and should be submitted as a part of the clinical evaluation materials during registration application. Post marketing clinical follow up pmcf is a continuous process that updates the clinical evaluation which is the 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. Guideline on the clinical and non clinical evaluation. Acceptance of clinical data to support medical device. Technical guidance on clinical evaluation of medical devices 1. The clinical evidence guidelines for medical devices are intended to provide. If so, you must write and maintain a clinical evaluation report cer as part of your technical file submission. The clinical evaluation procedure governs the entire clinical evaluation process from scope definition through clinical evaluation report cer. Clinical evaluation of medical devices qserve group. Clinical evaluation reports cer for medical devices.
All medical devices will have to undergo an independent assessment of safety. The end result of this process is the production of a clinical evaluation report cer. Clinical evaluation report and supporting documents 4. An overview of common gaps in clinical evaluation reports. Clinical evaluation must be documented in a clinical evaluation report article 6112. Pdf on oct 15, 2018, vladimir rogalewicz and others published clinical and economic assessment of medical devices find, read. Technical guidance on clinical evaluation of medical devices 1 i.
General safety and performance requirements annex i in. Updating a clinical evaluation report cer in clinical, regulatory by dr. Among the many daily activities performed by a medical device manufacturer, uniform compliance to the mdr for technical documentation is an especially timeconsuming challenge. Recommendations for a national medical device evaluation. Clinical evaluation is regarded as an ongoing process conducted throughout the life cycle of a medical device. 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. Frequently asked questions guidance for industry and food and drug administration staff february 2018. Im asked to do the clinical evaluation for a medical device does any one have an exemple or template of regarding to the recommendation of the meddev 2. A good clinical evaluation report should support strong evidence that the subject medical device achieves its intended purpose without exposing users and patients to risk data collected, assessed, analyzed by the use a specific medical device on human beings by way of clinical trials, literature search, followup, market surveillance. Iso 109931 biological evaluation of medical devices part 1.
Clinical evaluation report and supporting documents 24. Qserve supports medical device manufacturers with their clinical evaluation during distinct phases of product development, underpinned by risk management activities. Pms and pmcf plans for medical devices and how to design. Although guidance is available on the requirements for clinical evaluation, it is not comprehensive. 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. Changes in eu clinical data requirements and expectations. Medical device clinical evaluation report cer tips 2. The new eu medical device regulation 2017745 requires that risk management and clinical evaluation merge to form interdependent and aligned processes, and it places much higher scrutiny on ensuring there is sufficient clinical evidence to support general safety and performance requirements for a medical device. The clinical evaluation report should reflect the current understanding of the benefits and risk of a medical device. At qserve group, we are here to help analyze and identify a wide array of potential gaps across clinical evaluation reports, as well as technical documentation such as design dossiers and technical files. Clinical evaluation and postmarket cl inical followup. This term is further explained in ghtf document sg5n1r8. Clinical evaluation requirements under european medical.
Medical device clinical evaluation reports for european ce marking. Clinical evaluation valid clinical association is there a valid clinical association between your samd output and your samds targeted clinical condition. Generating clinical evaluation reports a guide to effectively analysing medical. Clinical evaluation reports from the medical writers. 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. Bsi training clinical evaluation for medical devices. European clinical evaluation reports cer eu meddev 2. A8 devices for unmet medical needs aspects to consider a9 clinical evaluation report proposed table of contents, examples of contents a10 proposed checklist for the release of the clinical evaluation report a11 information on declarations of interests a12 activities of notified bodies. Assessment of clinical evaluation reports for medical devices. The clinical data and the clinical evaluation report pertaining to a medical device. Evaluation and testing within a risk management process. Requirements for clinical trials for medical devices with clinical trials conducted in china, these trials should. The clinical evaluation report course overview this twoday introductory course will cover all aspects of clinical evaluation in line with the european medical device regulation mdr and applicable guidance documents.
Mcda can combine outcome parameters of the particular. 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. Medical devices clinical evaluation report presentation guide the elements of the clinical evaluation report are records of the process that the manufacturer applies to the identification, selection, appraisal and critical analysis of clinical data in order to meet the applicable essential requirements of medical devices directives. The clinical evaluation report cer is the document containing this information, and is. The clinical data include current knowledge of the condition to be treated, published. Any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety andor performance of a medical device. A clinical evaluation report cer documents the conclusions of a clinical evaluation of your medical device. The clinical data include current knowledge of the condition to be treated, published literature about the target device and any equivalent devices, information held by the manufacturer about pre clinical and clinical investigations, risk management. Abstract clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device.
Pdf the european medical device regulation 2017745 mdr will be operational starting in may 26, 2020. Clinical evaluation reports from the medical writers perspective. The active implantibles medical device directive of 1990 discussed the. Medical writing medical devices clinical evaluation. The medical devices directive and its corresponding guidelines state that in the case of implantable devices, active implantable devices and devices of class iii, evidence of the clinical performance and safety of a medical device is provided by means of clinical data. Clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended. The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device. 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. The new european union medical devices regulation deloitte. While the approach to clinical evaluation described in meddev 2. 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. Latest clinical evaluation report for medical device. Clinical evaluation requirements under european medical device regulation, impact on businesses, and brussels update maria e. 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.
Is the process for managing and preparing clinical evaluation report cer. My whitepaper today is to combine the cardiovascular message from. 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. Clinical evaluation report cer with rev 4 in effect already and mdr in horizon in next couple of years, developing and maintaining clinical evaluation reports cer becomes higher priority for device manufacturers unlike previous versions, cer rev 4 has some of the requirements that are very different and just updating based on literature strategy alone will increase your risk of rejection. Clinical evaluation report dr hos muscle therapy unit modulated tens device prepared by stuart m.
Think of the clinical evaluation report as a threelegged stool. Evaluation of clinical data as described in annex x of the mdd and annex 7 of. Mcgill, phd, professor, and jordan cannon department of kinesiology, faculty of applied health sciences, university of waterloo june 2014. We are experts in performance excellence and regulatory compliance we merge our expertise in regulatory compliance. Technical guidance on clinical evaluation of medical devices. Iec62366 medical devices application of usability engineering to medical devices.
Pdf clinical and economic assessment of medical devices. Optimizing clinical evaluation reports within the medical device lifecycle medical device, medical device clinical trials, medical device safety and regulation. A practical approach to clinical evaluation that fulfills. Therapies tvt registry linked to administrative claims data to combine robust device and. Every medical device sold into europe, irrespective of its classification, must have an uptodate clinical evaluation report cer as part of its technical file. Acceptance of clinical data to support medical device applications and submissions. Pdf the european medical device regulation 2017745eu. Device directive mdd, 9342eec and active implantable medical device directive. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical. The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety, performance and effectiveness of the device when used as intended by the manufacturer. Since our last update on cer execution a renewed guidance in the form of meddev 2.
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