The Government has announced its intention to amend the Medical
Devices Regulations 2002 for Great Britain to incorporate EU
Common Specifications for high-risk in vitro diagnostic (IVD)
devices and to repeal regulations on Coronavirus Test Device
Approvals (CTDA).
Respondents overwhelmingly supported a
proposal to repeal the current CTDA process for COVID-19
devices and to replace current requirements with Common
Specifications. In the interim, an accelerated CTDA process will
be introduced for COVID-19 devices that have CE marking under the
European IVD regulations (EU IVDR) and meet Common Specification
requirements.
The Common Specifications will also enhance performance standards
for IVD devices related to infectious diseases including
Hepatitis B, C and D, HIV and Syphilis, as well as devices for
blood grouping and tissue typing. These diagnostic tools are
critical for effective patient care and public health
management.
The move aims to ensure these vital IVD devices, which test
samples from the human body to monitor health or manage disease,
meet high standards of performance backed by robust clinical
evidence.
Rob Reid, Deputy Director of Innovative Devices at the
MHRA, said:
By aligning with standards already in place across Europe, we're
not only enhancing patient safety but also making it easier for
manufacturers to navigate regulatory requirements across
different markets.”
These new specifications will be introduced in regulations
expected to be published later this year as part of the
Government's broader programme of medical devices regulatory
reform, which supports the NHS transformation.
The changes reinforce the Government's commitment to reduce
regulatory burden and balance robust patient safety measures with
support for innovation in the medical technology sector.
ENDS
Notes to editors
-
Common Specifications refers to a set of standardised
technical and performance requirements developed at the
European level for certain high-risk in vitro diagnostic
(IVD) medical devices.
-
In vitro diagnostic (IVD) devices are medical tests used to
examine samples like blood, urine, or tissue taken from the
human body to help detect, diagnose, or monitor diseases and
health conditions.
