25
KIT
performance, and post-market
surveillance requirements.
Abrams continues, "The fact is
that not all insulin bolus calculators
currently available meet these strict
requirements. Some are not CEmarked,
meaning they lack regulatory
oversight for safety and performance,
while others are CE-marked under a
lower classification (e.g., Class I) and
therefore undergo a less rigorous
regulatory process (for instance they
are not subject to an assessment by a
Notified Body), with uncertain clinical
benefits and safety.
"A key distinction is that Class IIb
devices are subject to strict postmarket
surveillance requirements,
ensuring continuous monitoring of
safety, performance, and potential
risks. Maintaining the CE mark under
MDR is not a one-time certification
but requires ongoing demonstration
of clinical benefits and safety. This is
enforced through regular audits by
an independent Notified Body, postmarket
clinical follow-up studies,
and periodic safety update reports.
These processes involve real-world
data collection, clinical studies, and
proactive risk management, ensuring
HDA continues to meet regulatory
and clinical standards."
To read more about Hedia and
Glooko, see the article on page. TK.
*in speech Class IIb is pronounced
'class two b'
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