The following devices in Great Britain (England, Wales and Scotland) need to be registered with the MHRA under existing arrangements:
- Class I medical devices
- IVDs (including all IVDs undergoing performance evaluation)
- custom-made devices
- systems and procedure packs
All other classes of device placed on the Great Britain market require registration with the MHRA subject to grace periods, depending on the class of devices.
In Great Britain devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be registered with the MHRA…