Skip to main content
Blog-Banner (1)

Medical Devices-USA/Europe Regulatory News – August 2023

|

 

 

 

  • Reiterates the obligation already established in Regulation (EU) 2017/745 for all class III implantable medical devices that institutions and healthcare professionals have supplied and received
  • Introduces the same requirement for all class III and class IIb implantable medical devices

 

  • Getting your device certified
  • Conformity marking your device
  • Registering your device with the MHRA
  • Class I, IIa, IIb or III devices you have manufactured
  • Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name
  • Any system or procedure pack containing at least one medical device
  • Custom-made devices
  • IVDs you have manufactured
  • IVDs undergoing performance evaluation
  • Contact details to report a non-compliant medical device
  • Information on MHRA’s enforcement duties after receiving a complaint
  • Adverse reactions
  • Inadequate sterilization
  • Insufficient mechanical strength and/or structural integrity
  • Insufficient durability
  • Misuse due to lack of adequate training for the device
  • Classification
  • Custom-made prosthetic, orthotic and ophthalmic devices
  • Examples