EU Approves Eighth Notified Body

The EU named Netherlands-based Dekra Certification as its eighth notified body under the European Medical Device Regulation (MDR) which tightens marketing authorization requirements for devicemakers.

Devicemakers have had three years to prepare for transition to the new regulations, but there is a severe shortage of notified bodies to do the certifications.

The clock is ticking to designate more notified bodies before the MDR goes into effect on May 26, 2020. The EU proposes to allow low-risk Class I devices four more years to comply with the MDR, extending the compliance date to May 26, 2024.