Drugdu.com expert's response:

The EU Medical Device Regulation (MDR) aims to ensure the safety and efficacy of medical devices through its requirements for clinical evaluation. The specific requirements are as follows:

I. Clinical Evaluation Plan

Purpose and Scope: The clinical evaluation plan should clearly outline the objectives, scope, methods, and timeline of the evaluation, taking into account the intended use, risks, and expected clinical outcomes of the medical device.

Clinical Data Collection and Analysis: It should describe how clinical data related to the medical device will be collected, analyzed, and evaluated, including the selection of patient populations, data collection methods and time points, and statistical methods for data analysis.

Design and Management of Clinical Trials: If clinical trials are required, the plan should detail the design and management of the trials, including participant selection criteria, trial arrangements, duration, supervision, and management.

Reporting of Clinical Evaluation Results: It should specify how the evaluation results will be reported, including evidence of clinical effectiveness, safety, and intended use. The results should be based on scientific evidence and comply with statistical and clinical practice requirements.

Risk Management: The plan should consider risk management and describe how to monitor and assess potential adverse events and side effects, including regular safety assessments and risk-benefit ratio evaluations.

II. Types and Pathways of Clinical Evaluation

Equivalence Pathway: Applicable to all medical devices, including new and legacy devices. It requires demonstrating comparability with already-marketed equivalent devices in terms of technical, biological, and clinical characteristics. This includes technical equivalence (identical or similar design, materials, manufacturing processes, etc.), biological equivalence (consistent biocompatibility, toxicity, degradation characteristics, etc.), and clinical equivalence (no significant differences in intended use, patient population, clinical effectiveness, etc.).

Exemption from Clinical Research Pathway: Applicable to design-improved versions of implantable or Class III devices. It requires demonstrating equivalence with the original device in terms of technical, biological, and clinical characteristics and developing a Post-Market Clinical Follow-up (PMCF) plan to continuously monitor post-market data.

Cross-Manufacturer Equivalence Pathway: Applicable to already-marketed devices from other manufacturers. It requires signing a contract to ensure continuous access to the technical documentation of the equivalent device and verifying that the Clinical Evaluation Report (CER) of the equivalent device complies with MDR requirements.

Legacy Device Pathway: Applicable to implantable or Class III devices previously certified under the Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD). It requires integrating historical data and new PMCF data to demonstrate compliance with MDR requirements.

Mature Technology Device Pathway: Applicable to devices with simple designs, long-term market validation, and no significant safety incidents (e.g., sutures, dental fillings). It requires providing at least 5-10 years of market safety records and may reference clinical data from similar products.

Non-Clinical Data Pathway: Applicable to low-risk devices with no direct clinical benefits (e.g., laboratory equipment, non-invasive tools). It requires demonstrating safety through non-clinical data (bench testing, simulated use).

III. Clinical Data Requirements

Data Rationality and Reliability: Clinical data should be based on scientific principles and appropriate research designs to obtain reliable, accurate, and meaningful results.

Design and Conduct of Clinical Trials: If clinical trials are required, they should comply with relevant scientific and ethical principles and obtain appropriate informed consent from participants. The trial design should be reasonable and adopt appropriate sample sizes, control groups, endpoint indicators, and data collection methods.

Patient Selection and Recruitment: Patient selection should be based on the purpose of the clinical evaluation and ensure representativeness and applicability. Recruitment criteria should be clear, including patient demographic characteristics, disease status, and special requirements for specific subgroups.

Data Collection and Analysis: Patient data should be systematically collected, recorded, and analyzed. The data should include primary and secondary endpoint indicators related to safety and performance and be analyzed using appropriate statistical methods.

Safety Assessment: The safety of the medical device should be assessed, and potential adverse events and complications should be monitored and reported. Clinical evaluation data should provide information on potential safety and risk issues.

Literature Review and Data Assessment: Relevant scientific literature should be reviewed and assessed and incorporated into the data support for the clinical evaluation. This includes a comprehensive analysis of literature on similar devices, similar studies, or related treatment plans.

IV. Specific Requirements

Equivalence Demonstration: When demonstrating equivalence, technical characteristics (including software algorithms), biological characteristics (e.g., materials, substance release characteristics), and clinical characteristics (e.g., user type, clinical conditions, or purpose) should be considered.

Risk Management and Monitoring: An effective risk management system should be established, and the performance and safety of the product on the market should be monitored. Manufacturers need to regularly assess clinical data and relevant scientific literature, analyze and manage risks, and take necessary measures to ensure the safety and performance of the product.

Post-Market Clinical Follow-up (PMCF): The MDR emphasizes the need for post-market clinical follow-up of medical devices and requires manufacturers to conduct PMCF activities to collect, analyze, and evaluate clinical data related to the product.