4.5-4.6 Final analysis, conclusion, and continuous update
Source: MDCG 2020-1 (March 2020), pages 15-16
4.5 Final analysis and conclusion of the clinical evaluation (MDR) / performance evaluation (IVDR)
The manufacturer should compile evidence, perform the benefit-risk analysis and document the CLINICAL or PERFORMANCE EVALUATION and its output in the CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) report.
4.6 Continuous update of the clinical evaluation (MDR) / performance evaluation (IVDR)
The safety, effectiveness and performance of the MDSW should be actively and continuously monitored by the manufacturer.
Such data may include, but is not limited to post-market information such as complaints, PMCF/ PMPF data, REAL-WORLD PERFORMANCE data, direct end-user feedback or newly published research / guidelines and should be subject to the CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) principles depicted in Figure 1.
The unique level of connectivity of MDSW facilitates access to REAL-WORLD PERFORMANCE data, which can be used for multiple purposes, including, but not limited to
- timely detection and correction of malfunctions;
- detection of systematic misuse;
- understanding user interactions;
- to conduct ongoing monitoring of CLINICAL PERFORMANCE;
- to improve effectiveness;
- develop the claims in the CLINICAL DEVELOPMENT PLAN (MDR) or future releases.
MDSW can be released for CE marking with initially claimed and validated CLINICAL BENEFITS. Monitoring of REAL-WORLD PERFORMANCE data can help formulate hypotheses about future MDSW functionalities and intended use(s).