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. Mcgill, phd, professor, and jordan cannon department of kinesiology, faculty of applied health sciences, university of waterloo june 2014. Technical guidance on clinical evaluation of medical devices 1 i. 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. The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device. 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 evidence from the clinical evaluation will be documented in the cer and it shall be a part of the technical documentation which will support the assessment of the conformity of the device.
Clinical evaluation requirements under european medical. Clinical evaluation of medical devices qserve group. 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. Any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety andor performance of a medical device. Evaluation of sexspecific data in medical device clinical. Updating a clinical evaluation report cer in clinical, regulatory by dr. The european medical device regulati on 2017745 mdr 1 passed the european parliament. You will understand the detail of what clinical data is. Council directive 90385eec as amended by directive 200747ec. Among the many daily activities performed by a medical device manufacturer, uniform compliance to the mdr for technical documentation is an especially timeconsuming challenge. Clinical evaluation and the clinical evaluation report 3 2.
Technical guidance on clinical evaluation of medical devices. An overview of common gaps in clinical evaluation reports. The clinical evaluation report documents the results of the clinical evaluation done for a medical device. Manufacturers should take into account medical device reporting mdr requirements for the periodic safety update report and the summary of clinical performance. Clinical evaluation procedure bundle medical device consultants. A practical approach to clinical evaluation that fulfills the. These guidelines align very closely with regulations expected. The clinical evaluation report should reflect the current understanding of the benefits and risk of a medical device. A possible format for a clinical evaluation report. 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. Clinical evaluation requirements under european medical device regulation, impact on businesses, and brussels update maria e. Acceptance of clinical data to support medical device applications and submissions.
Qserve supports medical device manufacturers with their clinical evaluation during distinct phases of product development, underpinned by risk management activities. Go through the provided guide to get useful information on the various aspects of making such reports. Clinical evaluation is regarded as 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. Clinical evaluation report dr hos muscle therapy unit modulated tens device prepared by stuart m. Requirements for clinical trials for medical devices with clinical trials conducted in china, these trials should. 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. The cer and the clinical data are used together to prove the conformity of the medical device to the general safety and performance requirements. 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. Refer to the given pdf sample for getting a useful format of a clinical evaluation report.
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. Medical device investigations can be defined as systematical research or studies carried out on the volunteers to evaluate the safety andor performance of the medical device in one or more than one centers. Understanding the changes to clinical evaluation guideline. An overview of common gaps in clinical evaluation reports cers and technical documentation under the mdr among the many daily activities performed by a medical device manufacturer, uniform compliance to the mdr for technical documentation is an especially timeconsuming challenge. 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 investigation. 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.
In june 2016, the updated medical device clinical evaluation report cer guidelines came into effect revision 4 of meddev 2. The results of this process are documented in a clinical evaluation report. A clinical evaluation report cer documents the conclusions of a clinical evaluation of your medical device. The role of literature searches in obtaining regulatory approval. These guidelines align very closely with regulations expected to come into effect in the next few years. Council directive 9342eec as amended by directive 200747ec. The purpose of this guidance is to outline the fdas expectations regarding. The clinical evaluation procedure governs the entire clinical evaluation process from scope definition through clinical evaluation report cer. A clinical evaluation report cer for medical device is a document that contains the conclusions of the clinical evaluation performed on the medical device based on all relevant clinical data available the cer and the clinical data are used together to prove the conformity of the medical device to the general safety and performance requirements. Clinical evaluation needed to demonstrate the safety and performance of manufacturers devices.
Whereas the performance evaluation studies realized with invitro medical. The report has been structured systematically for the ease of putting information and analyzing. The safety and performance of this medical device is related to the procedure and well. 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. Medical device clinical evaluation report sample free. This webinarcourse provides a guideline on how to prepare a clinical evaluation for a medical device, considering the applicable laws and. Technical guidance on clinical evaluation of medical devices 1. 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. 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. It is first performed during the conformity assessment process leading to the. Clinical investigations of medical devices guidance for. Assessment of clinical evaluation reports for medical.
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. Ghtf sg5 clinical evaluation international medical device. The clinical evaluation report must include all clinical evidence required to support medical device conformity assessments in the eu. Frequently asked questions guidance for industry and food and. 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. In general, however, a clinical evaluation process includes the following steps. 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. Clinical evaluation is defined as the assessment and analysis of clinical data pertaining to a medical device in order to verify its clinical safety and performance when used as intended. 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. The cer demonstrates that your device achieves its intended purpose without exposing users and patients to further risk. This twoday introductory course will cover all aspects of clinical evaluation in line with the european medical device regulation mdr and applicable guidance documents. 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 scope and depth of a clinical evaluation required for a given medical device depends on several factors, including the level of risk posed by the device and the specific regulatory requirements of a jurisdiction. 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.
This document provides guidance on the study and evaluation of sexspecific data in medical device clinical studies. The purpose of the evaluation is to assess whether the available clinical evidence is sufficient to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturers instructions for use ifu. A clinical evaluation report cer thus contains the results of clinical evaluation and the clinical evidence on which it is based, which will support the assessment of the conformity of the device do you know before obtaining ce marking in the european union, the medical device manufacturers must prove that their devices meet the general safety and performance. 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. Checklist for your clinical evidence reports tuv sud. 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 preclinical and clinical. You can easily create such reports with the help of our medical report templates. The given pdf sample provides an elaborate guide on making a clinical evaluation report. Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. To pave the way for new medical device approvals that enable more efficient healthcare procedures while improving patient safety, outcomes and quality of life.
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. 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. The smw cer will be involved in development of highquality clincial evaluation reports, clinical evaluation plans, and related documents in compliance with meddev 2. Although guidance is available on the requirements for clinical evaluation, it is not comprehensive. Clinical evaluation reports from the medical writers. Clinical evaluation and clinical investigation update mdr. The requirement for clinical evaluation of medical devices was originally set out by eu legislation in the early 1990s, with the clinical evaluation being defined in annex x of the medical devices directive mdd1 and annex 7 of the active implantable medical devices directive aimdd2. The report is performed in accordance with meddev 2. The new requirement a 2007 amendment to the medical devices directive mdd 9342eec will come into force in march 2010. It includes information on the safety and effectiveness of a device, data from clinical trials, technical design description, literature searches and more. Freelance medical writer clinical evaluation reports cers.
However, for some specific types of devices, an analysis of the notified bodys cear by expert panels will be obligatory. Every medical device sold into europe, irrespective of its classification, must have an uptodate clinical evaluation report cer as part of its technical file. For example, the regulation outlines a clear expectation for notified bodies to provide a clinical evaluation assessment report cear. Tuv suds clinical center of excellence has compiled a checklist to support medical device manufacturers in making complete and correct submissions of clinical evidence. A guide for manufacturers and notified bodies under directives 9342eec and 90385eec, is the guidance. Any systematic investigation or study in or on one or more human. The role of literature searches in obtaining regulatory.
Clinical evaluation valid clinical association is there a valid clinical association between your samd output and your samds targeted clinical condition. Acceptance of clinical data to support medical 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. A practical approach to clinical evaluation that fulfills.
This document promotes a common approach to clinical evaluation for medical devices regulated by directives 90385eec and 9342eec. It is important to be wellversed with the various features of the report in order to prevent yourself from leaving out any important part. A clinical evaluation report cer for medical device is a document that contains the conclusions of the clinical evaluation performed on the medical device based on all relevant clinical data available. Medical device directive council directive 9342eec amended by. The regulatory framework for medical devices in the eu 3 3. President donawa lifescience consulting srl massmedic webinar 18 january 2018, 12. 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. While this project is supported through a cooperative agreement with fda, the views expressed in this paper are those of the planning board members, and do not necessarily reflect the official policies of the. This term is further explained in ghtf document sg5n1r8. In addition, the principles of clinical investigations of medical devices are set out in the.
647 43 653 1313 1404 1117 1286 754 232 1313 542 1470 844 617 1360 160 414 304 669 168 322 1033 408 258 93 215 984 158 676 177 895 107 486 769 526 482 861 355 937