Clinical Evaluation for CE certification
Clinical evaluation is a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
Clinical Evaluation Plan according to MDR requirements
The clinical evaluation plan is the foundation of the overall clinical evaluation process and provides the roadmap for the process. The clinical evaluation plan outlines the essential steps for defining the scope, regulatory pathway, and necessary procedures to systematically and methodically collect the required clinical data for the device being evaluated.
A CEP under MDR:
● Identifies the general safety and performance requirements that require clinical data.
● Includes the intended purpose of device.
● Includes the intended target group with clear indications and contraindications.
● Specifies the clinical benefits to patients with relevant and specified clinical outcome parameters.
● Specifies the methods used for qualitative and quantitative aspects of clinical safety to determine residual risks/ side effects.
● Includes Clinical development plan.
● Specifies the parameters to determine state-of-the-art and acceptability of benefit-risk for all indications.
Literature Search
● Preparation of search terms related to state-of-the-art and device under evaluation.
● Identification of database.
● Definition of inclusion and exclusion criteria.
● Analysis and appraisal criteria definition.
● Execution of literature search.
● Preparation of Literature Search Report.
Vigilance Data Analysis
● Collecting and analyzing reports of device-related incidents.
● Identifying and evaluating trends in vigilance data to detect potential safety issues.
● Investigating the root causes of reported incidents for accurate problem identification.
Clinical Evaluation Report according to MDR requirements
● Evaluation of outcome parameters.
● Establishing clinical background and state-of-the-art.
● Summarization of data held by manufacturer.
● Analysis and appraisal of various data .
● Performance and safety evaluation of device under evaluation.
Post market documentation according to MDCG guidance
● Post Market Surveillance Plan.
● Periodic Safety Update Report/ Post Market Surveillance Report.
● Post Market Clinical Follow-up Plan.
● Post Market Clinical Follow-up Report.
Response to Notified body comments
● Carefully reviewing and analyzing comments from the notified body.
● Preparing comprehensive responses and supporting documentation.
● Organizing and participating in meetings to clarify any issues raised.
● Ensuring all responses meet regulatory standards and requirements.
● Submitting responses promptly to avoid delays in the approval process.
510(k) Certification
A 510(k) certification is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device is safe and effective. This regulatory pathway is essential for manufacturers to legally market their medical devices in the United States.
510(k) Certification
● Identification of suitable predicate device.
● Guidance regarding the various testing to be conducted.
● Preparation of 510k dossier.
● Post submission support for requests from US FDA.