Medical device companies targeting the EU market are being confronted with significant regulatory changes for market access. 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.
What does this mean for your company? 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 that:
1. More medical devices will require clinical investigation;
2. Equivalence will be harder to demonstrate;
3. The level of evidence required for medical device studies will be higher;
4. There will be more focus on post-market surveillance (PMS).
We will further discuss how to best process this new clinical data in a way that is compliant and cost-effective, using an electronic data capture (EDC) system.
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