ARTICLE SUMMARY:
It is no secret that the EU Medical Device Regulation (MDR) is shaking up the industry, but it may come as a surprise to manufacturers of lower-risk, Class I devices that they may also be impacted. The deadline is May 26, 2020, so it is critical for makers of Class I devices to review the relevant regulatory changes and determine whether they need to take action to avoid a market withdrawal. By Peter Rose, Maetrics
Manufacturers of low-risk devices that fall into the Class I category under the current EU Medical Device Directive (MDD) may be under the assumption that only higher-risk devices are affected by the MDR, but that is not the reality.
