The Medicines and Healthcare products Regulatory Agency (MHRA) is reforming UK medical devices regulation to align with post-Brexit frameworks and address emerging technologies including AI-enabled devices. The reform covers CE marking recognition, in vitro diagnostics, point-of-care testing, registration requirements, and economic operator responsibilities. This active policy aims to modernise the regulatory pathway while maintaining safety and efficacy standards.
In response to: Impact of AI on the regulation of medical products
Implementing the Artificial Intelligence (AI) White Paper principles.
Implementing the Artificial Intelligence (AI) White Paper principles.
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
We’d value your views to help shape the introduction of a new regulatory framework for products supplied at the point of care.
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
In response to: Consultation on the future regulation of medical devices in the United Kingdom
We're looking for your views on how medical devices will be regulated across the United Kingdom (UK) in the future.
We're looking for your views on how medical devices will be regulated across the United Kingdom (UK) in the future.
We’d value your views to help shape the introduction of a new regulatory framework for products supplied at the point of care.
We're looking for your views on how medical devices will be regulated across the United Kingdom (UK) in the future.
We’d value your views to help shape the introduction of a new regulatory framework for products supplied at the point of care.