UK Independent Medicines and Medical Devices Safety Review published

The GMDN Agency welcomes the recent publication of the report of the UK ‘Independent Medicines and Medical Devices Safety Review’ and its recognition of the importance of consistent medical device identification, as the following recommendations make clear:

“2.114 At present the MHRA only maintain a list of devices at the lowest risk (Class I). They do not maintain a list of medium to higher risk devices (IIa, IIb and III). This is a function of current EU device regulatory structure. The MHRA may only find out a device is being used in the UK if there is a problem with that device. A register of devices similar to the Australian Register should be created and maintained by the MHRA (Chapter 1, Recommendation 6). This will make it possible to know which devices are (or were) on the UK market at any given time…”

“2.116 Unique Device Identifiers (UDI) are alphanumeric identification codes for medical devices. There is a UDI catalogue in the US (GUDID), which is an accessible source of information on device characteristics, storage, handling and, importantly, premarket submissions including safety data. The EU devices database, (EUDAMED) is not currently operational and will not be so for some time. A public-facing UDI database for UK devices based on GUDID should be scoped. Interoperability with international regulator systems should be maximised to reduce data entry burdens.”

The Australian Register, the US (GUDID) and other national regulatory systems require the use of the GMDN for all medical device registration, as recognised in IMDRF UDI Guidance document N7.