In EU MDR, Annex XIV-Clinical Evaluation Plan says, "a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects"
Is clinical evaluation needed if device is already place on the market under MDD ?
What is the dofference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we was self-certificated before.
Is clinical evaluation needed if device is already place on the market under MDD ?
What is the dofference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we was self-certificated before.
Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation. Clinical investigations that are done after your product is placed in the market is Post Market Clinical Follow up (PMCF).
Should be: Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation investigation.
The Clinical Evaluation Report is prepare up front and is needed to get the CE Mark certification, The PSUR and PMCF are summaries of data collected after sale.
Recommend you read the MEDDEV guidance on clinical evaluation (2.7/1 rev 4), we based ours on this. It's a lengthy and detailed document so you need to put aside considerable time for this. If you meet the MEDDEV there is a presumption you meet the regulation.