This consultation applies to medical devices in Great Britain. For guidance on the
regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.
We are seeking views from stakeholders on four areas:
1. International reliance
Medical devices and in vitro diagnostic devices (IVD devices) can use the UKCA (UK
Conformity Assessed) process to access the Great Britain market either by selfcertification for low-risk devices, or by conformity assessment and certification by an
approved body. Approved bodies are organisations that have been designated by the
MHRA to assess medical devices.
In the future regulatory framework, the UKCA process would be complemented by an
international reliance scheme to enable swifter market access for certain devices that have
already been approved in a comparable regulator country. We are seeking views on the
proposed scheme…
