IVDR introduces 7 new, risk-based rules and highlights the fact that classification will be defined by the intended purpose.
The recent MDCG 2020-16 Guidance has shed some long-awaited light on the various aspects that need to be considered when classifying an IVD taking into account that >80% IVDs will require up-classification!
We summarize the clinical evidence required for legacy medica devices vs. well-established technology devices in the EU-MDR context.
The two concepts are often used as identical, which is not the case under EU-MDR requirements.
Refer to MDCG 2020-06 when going through this document!
Download the document here
A clinical evaluation report (CER) retrieves and appraises clinical data from various sources in order to provide evidence that a medical device is conforming with GSPRS. We have summed up the commonest sources for you.
This is a summary of the the major FDA application types for medical devices.
Inclusion of a Clinical Development Plan (CDP) is a new requirement of MDR that often confuses Manufacturers.
