Medical device real-world data – terms and definitions have been drafted for comments by China’s Center of Medical Device Evaluation (CMDE). It is proposed that these standards be implemented 12 months after their official release. Before finalization, the draft standards are open for public consultation, and relevant stakeholders are invited to provide feedback by October 8, 2024.
Overview of the Standards
- Scope
- The document defines the terms and definitions concerning real-world data for medical devices, including those used during real-world studies of medical devices.
- This document applies to the clinical evaluation of medical devices.
- Real World Data for Medical Devices: Terms and Definitions
This standard provides clear and precise definitions of key terms used in the context of real-world data and evidence related to medical devices. The document defines terms such as:
- Real-World Data (RWD): Data related to patient health and routine care collected from multiple sources outside traditional clinical trials.
- Real-World Evidence (RWE): The analysis of RWD to develop clinical evidence on the use, benefits, and risks of medical devices, which may be used for regulatory decision-making.
- Real-World Study (RWS): A study using real-world data to answer scientific questions through a multidisciplinary approach.
- Medical device registry: An organized system that continuously collects data relevant to routine clinical care, evaluates meaningful outcomes, and comprehensively covers medical device-exposed populations (e.g., international, national, regional, and health systems) on a reasonable scale, with the primary goal of improving the quality of patient care.
- Pragmatic randomized controlled trial (pRCT): An important type of pragmatic clinical trial that compares the outcomes of different interventions in clinical practice using a randomized, controlled design in a real or near-real healthcare setting, with the primary aim of evaluating the effectiveness of the intervention in routine clinical practice.
Here are all the terms included in the draft:
- Real-World data (RWD)
- Real-World evidence (RWE)
- Real-World study (RWS)
- Data Source
- Medical device registry
- Medical device registry data
- Medical record
- Hospital information system (HIS)
- Electronic medical record (EMR)
- Regional health care data
- Medical insurance data
- Health record
- Public monitoring data
- Patient-reported outcome (PRO)
- Mobile device-generated data
- Data quality evaluation
- Relevance
- Reliability
- Representative
- Completeness
- Attributive
- Consistent
- Repeatable
- Available when needed
- Real-world research design
- Interventional study
- Observational study
- Traditional clinical investigation
- Pragmatic clinical investigation
- Pragmatic randomized controlled trial (pRCT)
- Retrospective study
- Prospective study
- Retrospective and prospective study
- Statistical analysis terms
- Original data set
- Analysis data set
- Original database
- Analysis database
- Intention to treat (ITT)
- Bias
- Confounding
- Stratified analysis
- Propensity score
This standard is intended to improve the consistency and clarity of terms used in the clinical evaluation of medical devices, fostering more standardized communication and data interpretation across the industry.
Next Steps
- Review the Draft Standards: Evaluate the drafts for “Real World Data for Medical Devices: Terms and Definitions”.
- Provide Feedback: Submit your feedback, suggestions, or comments to cuixy@cmde.org.cn (Cui xinyue) before October 8, 2024.
Further information
Read the original CMDE announcement on Medical Device Real World Data Terms and Definitions Industry Standard – draft for comments.
Read our previous article on China medical device real-world evidence is increasingly important.
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