Clinical evaluation and clinical investigations articles 49 to 60 annex xiii. Clinical evaluation is regarded as an ongoing process conducted throughout the life cycle of a medical device. The guideline determining the structure and content of the cer is meddev 2. Clinical evaluation report proposed table of contents, examples of. Requirements for clinical trials for medical devices with clinical trials conducted in china, such trials should be. A guide for manufacturers and notified bodies under directives 9342eec and 90385eec provides helpful guidance on preparing the report on clinical evidence referred to as the performance evaluation report in the ivdr. In the past, it was common to have risk management files and clinical evaluations as separate, standalone documents. Bsi training clinical evaluation for medical devices. Pms and pmcf plans for medical devices and how to design. 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.
Requirements for clinical trials for medical devices with clinical trials conducted in china, these trials should. You will understand the detail of what clinical data is needed. Complying with european guidelines and the new meddev 2. Greater supervision over notified bodies the document currently states that notified bodies will be strictly supervised. Among the many daily activities performed by a medical device manufacturer, uniform compliance to the mdr for technical documentation is an especially timeconsuming challenge. Abstract clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. Class iii medical devices, and is not applicable to the clinical evaluation of invitro diagnostics administrated as medical devices. 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. 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. It is first performed during the conformity assessment process leading to the. Medical device clinical evaluation report cer tips 2.
If so, you must write and maintain a clinical evaluation report cer as part of your technical file submission. Although written for medical devices, not ivds, the meddev 2. 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. The clinical evaluation report should reflect the current understanding of the benefits and risk of a medical device. In june 2016, the updated medical device clinical evaluation report cer guidelines came into effect revision 4 of meddev 2.
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. The cer is submitted along with the technical file to meet eu mdr requirements. Are you thinking of marketing your medical device in europe. Clinical evaluation valid clinical association is there a valid clinical association between your samd output and your samds targeted clinical condition. 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. Clinical investigations of medical devices guidance for.
Overview to market a medical device in the european market with a successful ce certification, manufacturers are obliged to submit a clinical evaluation report cer to the concerned notified bodies. 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. 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. A clinical evaluation report cer thus contains the results of clinical. Any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety andor performance of a medical device. Requirements of the medical devices directive to be superseded by the medical devices regulation. Since our last update on cer execution a renewed guidance in the form of meddev 2. These guidelines align very closely with regulations expected to come into effect in the next few years. It has a stagewise explanation of the clinical evaluation. Medical device directive mdd 9342eec as modified by 200747ec. Pdf directive 200747ec1 amends the earlier medical device and active. 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.
The clinical evidence requirements described in this guidance apply in all these instances. 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. 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. Clinical evaluation of medical devices qserve group. Medical device clinical evaluation reports webinar cd. 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. An overview of common gaps in clinical evaluation reports.
Another leg is a report on your unpublished data, such as biological safety data, bench testing data, or complaint and experience records. The cer is a major portion of the technical file even though it is a. The european medical device regulati on 2017745 mdr 1 passed the european parliament. A greater emphasis on clinical trial data and evaluation under mdr, equivalence will be more thoroughly interpreted, likely making it much more challenging to demonstrate clinical safety or performance for medical devices. The eu directives emphasize the importance of the cer and include specific requirements for clinical evaluation. A possible format for a clinical evaluation report. This term is further explained in ghtf document sg5n1r8. 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. The clinical evaluation report cer is the document. The clinical evidence guidelines for medical devices are intended to provide guidance to manufacturers of medical devices including in vitro diagnostic medical devices ivds on what constitutes clinical evidence and the process of clinical data generation and clinic al evaluation to. Qserve supports medical device manufacturers with their clinical evaluation during distinct phases of product development, underpinned by risk management activities. Requirements for clinical trials for medical devices with clinical trials conducted in china, these trials should be conducted by. The clinical evidence guidelines for medical devices are intended to provide guidance to manufacturers of medical devices including in vitro diagnostic medical devices ivds on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence. 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.
Structure and content of clinical study reports pdf 240kb. Updating a clinical evaluation report cer in clinical, regulatory by dr. 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. Clinical investigations of medical devices january 2020 418 6. The clinical evaluation and its documentation must be actively updated with data obtained from the postmarket surveillance. In case there is technical guidance on clinical evaluation of specific medical device product available, it should be followed for the clinical evaluation of the corresponding product. Understanding the changes to clinical evaluation guideline. Clinical evaluation report dr hos muscle therapy unit modulated tens device prepared by stuart m. A clinical evaluation report should be prepared see annex 7 for the format after completion of the clinical evaluation, and should be submitted as a part of the clinical evaluation materials during registration application. A practical approach to clinical evaluation that fulfills the. The clinical evaluation report cer is a mandatory document for medical devices that are to be placed in the eu market. This documentation shall be included andor fully referenced in the technical documentation of the device.
Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation chapter vi. 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. Clinical evaluation undertaken for the development of a medical device. 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 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. Best road map for eu mdr clinical evaluation plan i3c. Although guidance is available on the requirements for clinical evaluation, it is not comprehensive. The report is performed in accordance with meddev 2.
Technical guidance on clinical evaluation of medical devices. The role of literature searches in obtaining regulatory. A coordinating center for a 21st century national medical device evaluation system national medical device evaluation system planning board report april 2016. Stage 0 contains the scoping and the planning of the clinical evaluation which specifies the contents as below.
These software changes in aiml based samd, grouped by the types of changes as described above, have different impact on users. Karen becker, john whyte extent ph 360 p, hardback priceisbn. Clinical evaluation report sample contents i3cglobal. Union, the medical device manufacturers must prove that their devices meet the. 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 clinical data and the clinical evaluation report pertaining to a medical device. Clinical evaluation latest development in expectations. 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. 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. Pdf the european medical device regulation 2017745eu. The regulatory framework for medical devices in the eu clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. Ce certification clinical evaluation as per meddev 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 results of this process are documented in a clinical evaluation report.
Manufacturers should take into account medical device reporting mdr requirements for the periodic safety update report and the summary of clinical performance. The main challenge for device companies in developing a clinical evaluation report cer is making the justification that the available data is sufficient to support the safety and performance of a device. Clinical evaluation report, cer, medical device regulation. Technical guidance on clinical evaluation of medical devices 1.
Nov 27, 2017 in the past, it was common to have risk management files and clinical evaluations as separate, standalone documents. Jun 25, 2018 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. One leg is a report of any newly conducted clinical investigations on your device. Medical writing medical devices clinical evaluation. Technical guidance on clinical evaluation of medical devices 1 i. The clinical evaluation procedure governs the entire clinical evaluation process from scope definition through clinical evaluation report cer.
As such, clinical evaluations are an essential element of the risk management process applicable to medical. Design control guidance for medical device manufacturers 031997 inds for phase 2 and phase 3 studies chemistry, manufacturing, and controls information 052003 resources for you. Girish hirpara, regulatory consultant on kolabtree, provides a clinical evaluation report sample for medical devices to use as a template for mdr compliance. A clinical evaluation report cer documents the conclusions of a clinical evaluation of your medical device. The eu mdr expects risk management and clinical evaluation be interdependent processes, calling for careful alignment of the risk management system with the clinical evaluation. Clinical evaluation of medical devices linkedin slideshare. A guide for manufacturers and notified bodies under directives 9342eec and 90385eec, is the guidance. 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 is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. Every medical device sold into europe, irrespective of its classification, must have an uptodate clinical evaluation report cer as part of its technical file.
This list contains documents available at the time this meddev document was published. Clinical evaluation and post market clinical followup. Changes in eu clinical data requirements and expectations. 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. 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. In general, however, a clinical evaluation process includes the following steps. Customer clinical evaluation report cer validation.
Medical device clinical evaluation report sample free. The clinical evaluation report is a fourlegged table. The new requirement a 2007 amendment to the medical devices directive mdd 9342eec will come into force in march 2010. 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. Pdf clinical evaluations clinical investigations under the amended. Any systematic investigation or study in or on one or more human. 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 legal requirements as to methodology and ethical considerations relating to clinical investigations are set out in the medical devices regulations 2002 section 16 and section 29, the active implantable medical devices directive annexes 6 and 7, and the medical devices. The clinical data and the clinical evaluation report.
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