MDD Legacy Device Transition Period Ends: Class III, IIb implantable

MDD legacy devices that are Class III or Class IIb implantable* under the MDR are no longer recognized. To continue placing these devices on the market, they must be CE Marked to the MDR.

This is outlined in the MDR Article 120(3a), which establishes the timeframe through 31 December 2027, as long as the conditions outlined under Article  120(3b) are met:

“Devices which have a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article may be placed on the market or put into service until the following dates: (a) 31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors; (b) 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.“

Any international authorizations leveraged via the MDD legacy device status likely also expire today, e.g., Australia, UK, Switzerland. 

*The following implantable devices have an extended timeframe: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors