An Overview of Medical Device Clinical Evaluation
The clinical evaluation of medical devices and related reports is mandatory documentation as per EU MDR 2017/745 ARTICLE 61. The scope of the clinical evaluation should cover the devices included in this report, such as products, models, sizes, software versions, and accessories. Additionally, provide information on whether the device is currently on the market, the duration it has been available, the regions it is available in, the device’s history, any updates to the plan including modification dates, reasons for the modifications, and descriptions. It’s also important to mention sales volumes, and changes since the last report, and identify the sections of the clinical evaluation report that have been updated with new information.
Quality Management System (EN ISO 13485:2016) on Clinical Evaluation
· During the Design stage of the medical device the Clinical evaluation shall be performed for the assessment and analysis of clinical data to verify the clinical safety and performance of the device when used as intended by the manufacturer.
· Design and Development of the medical device shall be validated based on the clinical evaluation report during the design stage as well as during a design change.
· Through the clinical evaluation, the conformity assessment of the safety and performance of the medical device should be demonstrated before it is released for use by the customer.
Guidance on Clinical Evaluation
· The method following in the clinical evaluation to collect, appraise and analyze clinical data on a medical device and to analyze whether there is enough clinical evidence should be the plan of the clinical evaluation.
· Identify the General safety and Performance requirement clauses that require the clinical data for compliance in the clinical evaluation plan.
· Before the evaluation medical device-specific properties and its intended purpose should be appropriate.
· The intended target groups and medical indications should be properly determined, and the risk-benefit profile should be analyzed and demonstration of acceptability of that profile based on current knowledge/ the state of the art in the medical fields concerned.
The clinical evaluation should be performed through different stages as below
· Stage 0: Scoping and the Clinical Evaluation Plan
· Stage 1: Identification of Pertinent Data
· Stage 2: Appraisal of each dataset in terms of its scientific validity, relevance and weighting.
· Stage 3: Analysis of the data
· Stage 4: The Clinical Evaluation Report
Post Market Surveillance
Post Market Surveillance (PMS) means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service to identify any need to immediately apply any necessary corrective or preventive actions
PMS activities should be planned, established, documented, implemented, maintained and updated in a manner that is proportionate to the risk class and appropriate for the type of device. PMS should be conducted for the device upon release into the market, irrespective of its CE marking.
PMS Report and PSUR
PMS report summarizes the results and conclusions of the analysis of PMS data to be prepared for Class I device. Periodic safety update report (PSUR) shall be prepared for Class IIa, Class IIb and Class III for each device and where relevant for each category or group of devices. The report should summarize the results and conclusions of the analysis of the post-market surveillance data.
The periodic safety update report preparation is detailed in the procedure for PSUR. The PMS report & PSUR shall be reviewed with the notified body during the surveillance audits or at a frequency of 6 months once a year or every two years and NB feedback will be incorporated, or appropriate action taken.
Post MARKET Clinical Follow-Up
A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety and performance (i.e., residual risks) of a device when used by its approved labelling
Collection of Clinical Data
For General PMCF, collect the feedback forms/survey forms and other sources of clinical data from the users. For the specific PMCF method, collect the respective clinical study report and conclusions from the CRO who conducted the study. The data obtained during the clinical study (General PMCF and Specific PMCF) should be analyzed as appropriate for the device performance, compatibility, clinical safety and benefit, and any adverse events that occurred.
From the data obtained during the analysis, the conclusion should be derived and recorded in the Analysis and Conclusion Form.
PSUR Submission
The PSUR for class III devices or implantable devices shall be submitted using the electronic system referred to in Article 92 to the notified body involved in the conformity assessment by Article 52. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
For devices other than those mentioned in the above paragraph, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
PSUR Conclusion and Analysis
This section outlines the conclusion and analysis of the evaluation. The device’s safety for continued sale is mentioned here. Also, include any additional warnings and cautions that need to be added to the user information of the device.
Conclusion
A Clinical Evaluation Report is needed to show the safety and performance of the medical device, using clinical data and other production and safety information. A Clinical Evaluation Report writer or consultant is required to gather, analyze, and present the clinical data clearly and comprehensively to the notified body. For further details, please reach out to the I3CGLOBAL team.
