Manufacturers should take into account medical device reporting mdr requirements for the periodic safety update report and the summary of clinical performance. 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. The cer is submitted along with the technical file to meet eu mdr requirements. Girish hirpara, regulatory consultant on kolabtree, provides a clinical evaluation report sample for medical devices to use as a template for mdr compliance. 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. Any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety andor performance of a medical device. The role of literature searches in obtaining regulatory. The cer and the clinical data are used together to prove the conformity of the medical device to the general safety and performance requirements. These software changes in aiml based samd, grouped by the types of changes as described above, have different impact on users. The clinical evaluation procedure governs the entire clinical evaluation process from scope definition through clinical evaluation report cer.
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. The new requirement a 2007 amendment to the medical devices directive mdd 9342eec will come into force in march 2010. The results of this process are documented in a 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 european medical device regulati on 2017745 mdr 1 passed the european parliament. Although guidance is available on the requirements for clinical evaluation, it is not comprehensive. 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. Stage 0 contains the scoping and the planning of the clinical evaluation which specifies the contents as below. The cer is a major portion of the technical file even though it is a. These guidelines align very closely with regulations expected to come into effect in the next few years. 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. 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 data and the clinical evaluation report pertaining to a medical device. The eu directives emphasize the importance of the cer and include specific requirements for clinical evaluation.
Nov 27, 2017 in the past, it was common to have risk management files and clinical evaluations as separate, standalone documents. Clinical investigations of medical devices january 2020 418 6. Although written for medical devices, not ivds, the meddev 2. In general, however, a clinical evaluation process includes the following steps. 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. This term is further explained in ghtf document sg5n1r8. It is first performed during the conformity assessment process leading to the. Any systematic investigation or study in or on one or more human. Technical guidance on clinical evaluation of medical devices. Clinical evaluation report, cer, medical device regulation.
Karen becker, john whyte extent ph 360 p, hardback priceisbn. The report is performed in accordance with meddev 2. Another leg is a report on your unpublished data, such as biological safety data, bench testing data, or complaint and experience records. The clinical data and the clinical evaluation report. Are you thinking of marketing your medical device in europe. Requirements for clinical trials for medical devices with clinical trials conducted in china, such trials should be. As such, clinical evaluations are an essential element of the risk management process applicable to medical.
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. Union, the medical device manufacturers must prove that their devices meet the. You will understand the detail of what clinical data is needed. 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. Complying with european guidelines and the new meddev 2. An overview of common gaps in clinical evaluation reports. Medical device clinical evaluation report cer tips 2. Technical guidance on clinical evaluation of medical devices 1. Customer clinical evaluation report cer validation. 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. Clinical evaluation of medical devices qserve group. Medical device clinical evaluation reports webinar cd. Clinical evaluation report sample contents i3cglobal.
Pdf clinical evaluations clinical investigations under the amended. 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. Clinical evaluation is regarded as an ongoing process conducted throughout the life cycle of a medical device. Clinical evaluation reports from the medical writers. Clinical evaluation undertaken for the development of a medical device. Among the many daily activities performed by a medical device manufacturer, uniform compliance to the mdr for technical documentation is an especially timeconsuming challenge. Medical device directive mdd 9342eec as modified by 200747ec. Medical writing medical devices clinical evaluation. 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. One leg is a report of any newly conducted clinical investigations on your device. A clinical evaluation report cer thus contains the results of clinical.
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 dr hos muscle therapy unit modulated tens device prepared by stuart m. The clinical evidence requirements described in this guidance apply in all these instances. Dukemargolis center for health policy healthpolicy. The guideline determining the structure and content of the cer is meddev 2.
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. Clinical evaluation valid clinical association is there a valid clinical association between your samd output and your samds targeted clinical condition. 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. Mcgill, phd, professor, and jordan cannon department of kinesiology, faculty of applied health sciences, university of waterloo june 2014. A coordinating center for a 21st century national medical device evaluation system national medical device evaluation system planning board report april 2016. Class iii medical devices, and is not applicable to the clinical evaluation of invitro diagnostics administrated as medical devices. Pdf directive 200747ec1 amends the earlier medical device and active. 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. Structure and content of clinical study reports pdf 240kb.
This list contains documents available at the time this meddev document was published. The clinical evaluation report should reflect the current understanding of the benefits and risk of a medical device. 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. 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. 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. In the past, it was common to have risk management files and clinical evaluations as separate, standalone documents. 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.
Updating a clinical evaluation report cer in clinical, regulatory by dr. Changes in eu clinical data requirements and expectations. If so, you must write and maintain a clinical evaluation report cer as part of your technical file submission. To pave the way for new medical device approvals that enable more efficient healthcare. 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. In june 2016, the updated medical device clinical evaluation report cer guidelines came into effect revision 4 of meddev 2. 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.
Medical device clinical evaluation report sample free. The clinical evaluation report cer is the document containing this information to support initial cemarking or ce renewal. 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. 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.
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 evaluation report is a fourlegged table. 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. Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation chapter vi. Clinical evaluation report proposed table of contents, examples of. 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. 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. Qserve supports medical device manufacturers with their clinical evaluation during distinct phases of product development, underpinned by risk management activities. This twoday introductory course will cover all aspects of clinical evaluation in line with the european medical device regulation mdr and applicable guidance documents. Requirements for clinical trials for medical devices with clinical trials conducted in china, these trials should. 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.
Pdf the european medical device regulation 2017745eu. Clinical evaluation and post market clinical followup. A possible format for a clinical evaluation report. Ce certification clinical evaluation as per meddev 2. Clinical evaluation of medical devices linkedin slideshare. Clinical evaluation reports a threelegged stool think of a clinical evaluation report as a threelegged stool. Pms and pmcf plans for medical devices and how to design. 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. 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.
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. Every medical device sold into europe, irrespective of its classification, must have an uptodate clinical evaluation report cer as part of its technical file. 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 and clinical investigations articles 49 to 60 annex xiii. Greater supervision over notified bodies the document currently states that notified bodies will be strictly supervised. 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. Abstract clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. This documentation shall be included andor fully referenced in the technical documentation of the device. Technical guidance on clinical evaluation of medical devices 1 i. The clinical evaluation and its documentation must be actively updated with data obtained from the postmarket surveillance. Bsi training clinical evaluation for medical devices. 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.
The clinical evaluation report cer is a mandatory document for medical devices that are to be placed in the eu market. 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. The clinical evaluation report cer is the document. Requirements for clinical trials for medical devices with clinical trials conducted in china, these trials should be conducted by. Best road map for eu mdr clinical evaluation plan i3c. 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 practical approach to clinical evaluation that fulfills the. Clinical evaluation latest development in expectations.
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. It has a stagewise explanation of the clinical evaluation. 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.
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