EU Medical Device Regulation (MDR) classification requirements explained

The European Union’s Medical Device Regulation (MDR), specifically Regulation (EU) 2017/745, has introduced new classification and certification requirements for medical devices, replacing the previous Medical Device Directive (MDD) system.

Under the MDR, devices are assigned to one of four risk classes based on their intended purpose, invasiveness, duration of use, and device type. Classification is determined by applying 22 specific rules outlined in Annex VIII, where the highest applicable rule governs the device. While Class I devices often allow for manufacturer self-certification, Classes IIa, IIb, and III typically require oversight from a notified body.

Notably, classifications from the previous MDD do not automatically transfer to the MDR. Manufacturers must re-assess their products under the new Annex VIII rules, though certain legacy devices may be eligible for transitional provisions.