As of May 25th 2017, the Medical Device Regulation (MDR) has replaced the long-standing Medical Device Directive (MDD). The impact of the Medical Device Regulation to the medical device industry is substantial as it requires the re-classification and re-registration of all medical devices currently on the market. Moreover, the Medical Device Regulation outlines new clinical data requirements for (maintaining) certification of medical devices. Besides requiring more clinical data collection throughout the product’s lifecycle, it also raises the bar for the level of evidence that is required.
In this white paper we will discuss four ways in which the Medical Device Regulation will impact your clinical study requirements, and we will provide links to useful resources.
In particular, we will discuss why:
- More medical devices will require clinical investigation
- Equivalence will be harder to demonstrate
- The level of evidence required for medical device studies will be higher
- There will be more focus on post-market surveillance (PMS)