Clinical evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and performance. The evaluation is based on a comprehensive analysis of pre and post-market clinical data relevant to the intended use. This includes data specific to the device as well as any data relating to devices claimed as equivalent by the manufacturer. The whole process is documented in a clinical evaluation report (CER).
In this post, we will go through the main requirements associated with clinical evaluation report, taking into consideration two main different regulations:
Also, four new documents add to the guidance on the summary of safety and clinical performance for manufacturers and notified bodies and highlight differences between the MDR and the MEDDEV 2.7/1(4):
- MDCG 2020-5 Clinical Evaluation – Equivalence
- MDCG 2020-6 Sufficient Clinical Evidence for Legacy Devices
- MDCG 2020-7 Post-market Clinical Follow-up (PMCF) Plan Template
- MDCG 2020-8 PMCF Evaluation Report Template
Before entering into the details of the requirements associated to the Clinical Evaluation process, we remind that4EasyReg offers a Clinical Evaluation Report Template fully aligned with the requirements of the EU MDR 2017/745. The template is designed to cover all the necessary parts of the clinical process, including literature search, equivalence and clinical investigation.
General Information about Clinical Evaluation
The goal of clinical process is to collect and analyze data in order to confirm that for a specific medical device there is sufficient evidence to compliance against the essential requirements for safety and performance.
In general, this methodology clinical investigation has to be performed following the IFU of the device; in exceptional cases where an instruction for use is not required, the collection, appraisal, and analysis are conducted taking into account generally recognized modalities of use. Clinical evaluation is the responsibility of the manufacturer and the clinical evaluation report is an element of the technical documentation of a medical device that should be included in the technical dossier.
When is clinical evaluation undertaken and why is it important?
Clinical evaluation is conducted throughout the life cycle of a medical device, as an ongoing process. Usually, it is first performed during the development of a medical device to identify data that need to be generated for market access. This process is mandatory for initial CE-marking and it must be actively updated thereafter.
Clinical evaluation is necessary and important because it ensures that the evaluation of safety and performance of the device is based on sufficient clinical evidence throughout the lifetime that the medical device is on the market. This ongoing process enables manufacturers to provide notified bodies and competent authorities with sufficient clinical evidence for demonstration of conformity of the device with the Essential Requirements throughout its lifetime (for example for CE marking, fulfillment of post-market surveillance and reporting requirements, or during surveillance procedures).
Who should perform Clinical Evaluation
The clinical evaluation should be conducted by a suitably qualified individual or a team. As a general principle, the evaluators should possess knowledge of the following:
- research methodology (including clinical investigation design and biostatistics);
- information management (e.g. scientific background or librarianship qualification; experience with relevant databases such as Embase and Medline);
- regulatory requirements; and
- medical writing (e.g. post-graduate experience in a relevant science or medicine; training and experience in medical writing, systematic review, and clinical data appraisal).experience if a degree is not a prerequisite for a given task.
The Product-life Cycle of a Clinical Evaluation
CDP (Clinical Development Plan)
At the start of the development process, the clinical development plan defines how sufficient clinical data for later clinical evaluation is collected. This may include exploratory investigations, feasibility, and pilot studies to confirmatory investigations; a proposal for possible PMCF activities can also be initiated at this stage.
CEP (Clinical Evaluation Plan)
Before conducting the clinical evaluation, the CEP defines the scope of the clinical evidence. Available pre- and clinical data, remaining residual risks, newly identified risks (from PMS/PMCF/complaints) as well as all other claims (also from marketing) are considered. Clinically relevant questions, as well as open questions from risk management, are generated. The search strategy is defined (sources, search terms, selection, and evaluation criteria) that is to be applied for the clinical evaluation.
CER (Clinical Evaluation Report)
The CER represents the results of the clinical evaluation. Clinical data is collected, selected, evaluated, and analyzed. It is checked whether the device meets the requirements for safety, performance, undesired side effects, and the benefit-risk ratio defined by the MDR. Furthermore, currently available alternative treatment options also have to be taken into consideration. Finally, the need for further clinical data is discussed (PMCF activities) and passed on to PMS.PMS, PMCF, SSCP
PMS (Post-market Surveillance), PMCF Post-market Clinical Follow Up)
In the PMS plan, the manufacturer defines how the device will be monitored after the market launch and what data is to be collected. Product-specific planning of activities needs to take into account the findings from the clinical evaluation and the device’s risk potential. The methodologies for analyzing the data and the criteria for the analysis are defined and should be state of the art. The manufacturer is responsible for collecting the data on the market proactively. PMCF is part of PMS and intended to close the gaps that could not be answered in the scope of the clinical evaluation (e.g. long-term behavior, monitoring of side effects, and contraindications).
SSCP(for Class III devices) (Summary of Safety AND Clinical Performance)
An SSCP report must be prepared only by manufacturers of class III and implantable devices. The report is referenced in the user manual or the label and is made publicly available via EUDAMED. The report must be understood by laypersons. The purpose of the report is to introduce the device in the context of its application and explain alternative therapeutic or diagnostic options as well as residual risks and undesirable effects. Before publication, the report is validated by the notified body.
Proactive Post-market Surveillance
The proactive PMS phase is where PMCF activities are conducted including evaluation of evaluating market data. The strategies originally defined in the PMS plan must identify reportable events such as vigilance cases and can be reported on time. Vigilance describes the reporting of serious incidents and field safety corrective actions to the authority. For this purpose, every manufacturer needs an appropriate system in which it ensures that the evaluation and analysis of such events are enabled and that the deadlines for reporting them may be adhered to. The results of PMCF activities are documented and analyzed in one or several PMCF reports. The conclusions of the PMCF report must make considerations for the clinical evaluation and risk management. Statistically significant increases in the frequency or severity of non-serious incidents or expected undesirable side effects must be reported to the responsible authority if they affect the benefit-risk ratio.
PSUR(IIA, IIB, III) PMS
The purpose of the PMS report is to gain insights into the behavior of the device on the market across the entire product life cycle. A PMS Report has been created for class I devices and includes a summary of the results from market data collected over the observation period, the outcomes are passed on to clinical evaluation. CAPA is defined and explained. These may then be used for further product development as well as for ensuring the device’s safety and compliance with the requirements of the regulation at all times during the lifecycle. A PSUR (periodic safety update report) is prepared for class IIa, IIb, and III products and it includes a summary of the results and CAPA as the PMS report does. In addition, the PSUR also includes the conclusions from the benefit-risk assessment and any critical results from PMCF.
Clinical Evaluation Training
An in-depth online and self-paced training focused on clinical evaluation topics has been developed by QualityMedDev Academy and it is fully available at this link (click in the image below for a full description of the course):
Conclusions
In conclusion, we have been through the main requirements associated with the Clinical Evaluation Report and related topics. Specifically, we went through the requirements associated with EU MDR 2017/745 and MEDDEV 2.7/1(4).
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