24KIT
In safe hands?
A look at new regulatory guidance for diabetes tech
in the UK as well as a look at classifications of medical
devices in Europe and the UK. By Sue Marshall.
How medical devices are
classified and marketed
matters. It's important
that they go through the
'proper channels' in order to gain
accreditation for use. After all, these
are devices that we are literally
putting our lives in their hands.
Regulatory approval is a process that
authorizes a product or activity to
comply with laws and regulations.
A collection of guidance has
been published by the Medicines
and Healthcare products Regulatory
Agency (MHRA) to update
manufacturers of medical devices on
new regulations.
The Post-market surveillance
(PMS) regulation for medical devices
in Great Britain which will come
into force on 16 June 2025. Its key
new requirements are enhanced
data collection, shorter timelines
for reporting serious incidents and
summary reporting to enable the
MHRA and manufacturers to identify
safety issues earlier, as well as clearer
obligations for risk mitigation and
communication to protect patients
and users. Businesses are encouraged
to start using the guidance straight
away so that they understand their
obligations and are ready to comply
with the regulations when they take
effect.
Laura Squire, MedTech Regulatory
Reform Lead and Chief Officer at the
MHRA, said, "The new Post-Market
surveillance regulations* will provide
us with more safety information
on medical devices in use in Great
Britain, allowing us to act swiftly
when needed to reduce potential
harm. This will enable not only the
MHRA, but the whole health system,
to better protect patients."
*This means that it's possible to
report issues after you have, for
example, started using a CGM or
pump and have had issues with its
use, for example getting an infection
at the site of the device when
inserted into your skin.
To find out more, CLICK HERE.
A certain class
There are various stages of
certifications and classifications
of medical devices in Europe and
the UK.
We have news of a new product
available in the UK called Hedia,
which is a bolus calculator that
works in conjunction with the Glooko
service, which sends info from homeusers' devices
(blood test meters,
CGM, insulin pumps and Smart
insulin pens) into clinics for HCPs to
see and give advice on.
Some apps are available despite
not being compliant with European
regulations. Ultimately, they have
not been proven to be safe for use by
people living with diabetes.
For Julia Abrams, CCO at
Hedia, the question is, Why does
the medical classification and
appropriate medical certifications
matter in a bolus calculator? She
explains, "Hedia Diabetes Assistant
was first CE-marked as a Class IIb*
medical device under the Medical
Devices Directive (MDD) in 2019.
In 2024, we underwent a new
conformity assessment as part of
the transition to the Medical Device
Regulation (MDR) and were certified
again as a Class IIb medical device. As
part of this process, an independent
Notified Body (a designated
regulatory organization) rigorously
assessed HDA's clinical evaluation,
risk management, and quality system
to ensure compliance with MDR."
This classification as a Class
IIb medical device is significant
because the MDR requires robust
clinical evidence to demonstrate
that the device's benefits outweigh
its risks while meeting strict safety,