Following the announcement by the European Commission to postpone the new Medical Device Regulation (MDR) by one year in order to prioritize the fight against the coronavirus outbreak;

Aliyah Farouk, Medical Devices Analyst at GlobalData, a leading data and analytics company, offers her view:

“The European Commission’s decision to postpone the application of the MDR is expected to disrupt approval and re-certification of devices, taking the pressure off many companies. The new MDR, set to come into action on 26 May 2020, required companies to undertake lengthy technical preparations needed for the market approval of their products. According to GlobalData estimates, there are over 200 coronavirus diagnostic products in the market with many more anticipated to be released in the coming months.

“Under the current Medical Device Directive (MDD) regulations, the in-house reuse of single-use devices is permitted through design modifications and cleaning/decontamination. However, the MDR states single-use devices are to be professionally remanufactured. With the COVID-19 pandemic causing shortages in personal protective equipment (PPE) such as facemasks, many institutions have had to reuse equipment in order to meet the demand.

“The postponement therefore takes into account the challenges of the coronavirus pandemic and the need for increased availability of vital medical devices across Europe. As the outbreak has heightened demands for certain devices, postponing the MDR ensures market disruptions for critical devices is limited.”