If they serve health care professionals (HCPs) in EU member states, manufacturers that provide personal protective equipment (PPE) or medical devices used by HCPs caring for known or suspected COVID-19 patients should familiarize themselves with a recent European Commission recommendation. This recommendation is designed to accelerate the time to market for these products, provided that safety is not compromised.
For more information on the recommendation and how it contrasts with the typical steps to commercialize medical devices under the EU Medical Device Regulation (MDR) and PPE under the EU PPE regulation, please see my recent client alert, “Accelerated access to EU market for COVID-19 medical devices and personal protective equipment.”