Bioelectronics Corp (BIEL)

[GetSeriousOK]

The assertion that Kelly Whelan has done ANYTHING for the MDR transition is laughable.

The MDR transition period timeline IS:

26 May 2026 for class III implantable custom-made devices
31 December 2027 for class III and implantable class IIb devices
31 December 2028 for non-implantable class IIb and lower risk devices
31 December 2028, for class I devices that are a higher class under the MDR.

https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-medical-device/eu-mdr-transition/eu-mdr-transition-extension#:~:text=On%2015%20March%202023%2C%20the,and%20implantable%20class%20IIb%20devices

The suggestion that they have done anything in preparation for regulations that won't take effect until December 2028 does not merit further consideration. That is simply not how Kelly Whelan operates.