Clinical Data Analysis
Clinical data analysis can be assisted by AI tools, significantly reducing the time required for literature selection and analysis, and improving data extraction accuracy.
Conduct comprehensive analysis using key datasets: select gold standards, consensus statements, and relevant outcome measures from high-quality studies or guidelines.
NMPA Requirements
Conformity with Essential Safety and Performance Principles (ESEP 2.1.1)
Per the Essential Principles of Safety and Performance of Medical Devices: Medical devices shall achieve the performance intended by the manufacturer, and shall be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or other persons. Any risks associated with their use must be acceptable when weighed against the benefits to the patient.
Clinical literature data shall be analysed qualitatively and/or quantitatively. Study results shall describe the disease type and diagnostic/therapeutic effect, demonstrating that the device achieves its intended purpose under intended conditions of use.
Conformity with Essential Safety and Performance Principles (ESEP 2.1.9)
Per the Essential Principles: Under normal conditions of use, based on the current state of the art, the benefits of the medical device performance shall outweigh any risks. All known and foreseeable risks, and any undesirable effects, shall be minimised and be acceptable.
Conformity with Essential Safety and Performance Principles (ESEP 2.2)
Per the Essential Principles: Based on regulatory requirements, medical devices may require clinical evaluation (where applicable). The conduct of clinical trials shall comply with the ethical principles of the Declaration of Helsinki.
EU MDR Requirements
GSPR Clauses Relevant to Clinical Evaluation
GSPR 1. Devices shall achieve the performance intended by the manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or other persons, provided that any risks constitute acceptable risks when weighed against the benefits to the patient.
GSPR 8. Under normal conditions of use, all known and foreseeable risks, and any undesirable effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device.
Clinical Evaluation Requirements
Sufficiency of Clinical Evidence
- The manufacturer shall identify and justify the level of clinical evidence needed to demonstrate conformity with relevant safety and performance requirements
- The level of clinical evidence shall be appropriate in light of the device characteristics and intended purpose
- Clinical evaluation shall be planned, conducted, and documented based on scientific methodology
Handling Special Circumstances
- In certain cases, conformity may be demonstrated on the basis of non-clinical testing methods
- The rationale for relying on non-clinical data shall be fully justified in the technical documentation
- Where clinical investigation is exempted, the justification shall be stated in the CER
State-of-the-Art Assessment Requirements
- Regularly updated to reflect technological advances
- Assessment of the current state of technological development
- Comparison of device performance against available alternatives
- Demonstration that risk control measures are consistent with the state of the art
General Methods for Safety, Performance and/or Efficacy Analysis
Qualitative Analysis
Patient benefit assessment: Positive impact of the device on patient health/clinical outcomes (e.g., reduction in mortality or morbidity; improvement of impaired physical function), considering the nature of the benefit (significant improvement in quality of life, simplified clinical management, improved physical function, symptom relief; correct or early diagnosis; identification of patients requiring treatment).
Quantitative Analysis
Benefit assessment through scales or clinical endpoints/standards/benefit types, or pre-identified health thresholds; benefits may be assumed based on non-clinical data (laboratory tests, animal experiments, anatomy and physiology).
Probability that a patient will experience one or more benefits.
Expected degree and duration of patient benefit, considering the state of the art and alternative approaches.
Safety Databases
Public databases contain adverse event and/or recall records related to medical devices. The following databases are searched to collect records relevant to the subject device and/or equivalent devices.
China NMPA Database
https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/index.html
International Databases
| Database | Link | Authority | Country |
|---|---|---|---|
| FDA MAUDE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm | Food and Drug Administration | USA |
| FDA Medical Device Recalls | http://www.fda.gov/Safety/Recalls/default.htm | Food and Drug Administration | USA |
| FDA TPLC | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm | Food and Drug Administration | USA |
| Swissmedic | https://fsca.swissmedic.ch/mep/#/ | Swissmedic | CH |
| BfArM | http://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html | Federal Institute for Drugs and Medical Devices | GER |
| MHRA | https://www.gov.uk/drug-device-alerts | Medicines and Healthcare Products Regulatory Agency | GBR |
| TGA | http://apps.tga.gov.au/PROD/SARA/arn-entry.aspx | Australian Government Department of Health | AUS |
Adverse event analysis includes:
- Adverse event incidence rates
- Listing of expected and unexpected adverse events, with risk control measures for unexpected events
- Serious adverse events in tabular form with event description, root cause, management, outcome, and device relatedness