The Regulation 2017/745 (MDR) requires that the demonstration of compliance with the General Safety and Performance Requirements for the medical device includes a Clinical Evaluation. This applies to any medical device, including Medical Device Software (MDSW).
Clinical Evaluation is an ongoing process, conducted throughout the life cycle of a MDSW, intended to produce, collect, analyze, and evaluate clinical data on a device for the purpose of verifying its safety, performance, and clinical benefits when used as intended by the manufacturer.
In order to help the manufacturers in fulfilling this requirement, two documents have been published: the MDCG document MDCG 2020-1: Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software and the FDA Guidance document “Software as a Medical Device: Clinical Evaluation”.
As stated in the MDCG 2020-1, the clinical evaluation process is structured into 5 stages: Planning, Data collection, Data evaluation, Data analysis, Documentation (Clinical Evaluation Report, CER).
The manufacturer must provide the following evidence:
- Scientific validity
- Technical performance/analytical performance
- Clinical performance
According to the FDA Guidance document, the essential conditions for proper clinical evaluation are the existence of a relationship between the software itself and a specific clinical condition, analytical validation of input and output data processing, verification of the clinical effectiveness of the device during treatment.
Regulatory Pharma Net (RPN) is available to provide your company with any updates on the medical device regulatory framework and to assist on all regulatory needs including the development of the clinical evaluation for your medical devices.
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