To confirm the compliance with the General Safety and Performance Requirements (GSPR) of the MDR, a clinical evaluation shall be based on “sufficient clinical data”.
The Medical Device Coordination Group has recently published a guidance (Sufficient Clinical Evidence for Legacy Devices) to help manufacturers of devices already CE marked according to Directives 93/42/EEC or 90/385/EEC in setting up an appropriate clinical evaluation.
The guidance states the main steps that a clinical evaluation process should be based on:
- Identification of the general applicable points of Annex XIV Part A of the MDR.
- Identification of the available clinical data on the concerned device (clinical investigation, PMS clinical data, PMCF studies, data retrieved from the scientific literature)
- Appraisal of the clinical data
- Generation of new clinical data (in case data are not adequately comprehensive to provide sufficient clinical evidence)
- Analysis of the clinical data to determine if the whole collected data demonstrate the compliance with relevant GSPR
Regulatory Pharma Net offers full regulatory support in the preparation of the clinical evaluation, please do not hesitate to contact us!