Medical Design Briefs - April 2022 - 8

Valve Technology Requirements
In short, under
the new MDR, suppliers
to medical
device
manufacturers
must be able to
deliver solutions consisting
of both products
and services -
for example, documents,
processes, and
infrastructure.
Compact, EnergyEfficient
Valve
Cleanroom manufacturing for medical device components ensures maximum purity. (Credit: Emerson)
processes, and infrastructure are in
place to, for example, hand out material
compliance certificates, successfully
hold audits, and implement the proper
information technology (IT) infrastructure
to manage change control and
component traceability. In addition,
notified bodies have the right and duty
to monitor and audit critical component
suppliers. This is a new aspect under the
MDR that medical device suppliers
should be aware of.
So, what can suppliers do under the
MDR to support medical device manufacturers
in this new regulatory environment?
There are three key aspects:
* First, suppliers should provide all relevant
documentation, including clear
technical specifications, drawings,
bills of materials, material certifications
(RoHS and REACH), ISO 9001
certificates, and quality agreements
between the manufacturer and supplier.
The supplier must also be knowledgeable
about these various documents
and be able to issue them in a
short period of time.
* Second, suppliers should have various
processes in place regarding change
control, audits, and a stage gate
process for new development projects.
* The third aspect involves infrastructure.
An enterprise resource planning
(ERP) system, for example, supports
8
Cov
component traceability from the subsupplier
to the customer. Suppliers
should also have trained and knowledgeable
experts on hand to tailor
their products and services according
to customer needs.
What Are Medical Devices?
The term medical device
refers to products that have a
medical purpose and are intended
by the manufacturer to be used on
humans. Examples include instruments,
apparatuses, machines,
implants, in vitro reagents, and
materials used either alone or in
combination with each other. In
addition, these devices have a
specific medical purpose and play
a critical role in patient diagnosis,
prevention, monitoring, treatment,
or alleviation.
Considering their important
functions, medical devices must
achieve the highest levels of accuracy,
reliability, and purity. These
criteria apply to ready-to-use
devices or machines, as well as to
the components installed in them.
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ToC
Technologies
Under the MDR
Valves, which represent
a core technology
in medical
equipment, play an
important role in a
variety of medical
products such as surgical
devices, ventilators,
and dialysis
machines. Current
trends in valve technology
as it pertains
to medical applications include miniaturization,
energy efficiency, and weight
reduction. For example, demand is
growing for compact, economical valve
units - particularly in battery-operated
or mobile medical devices in the home
care sector. In such applications, lesscomplex
fluid control systems are critical.
In order to optimize the flow path
and contribute to higher instrument
efficiency, fluidic components must
meet ingenious application requirements.
Such simpler designs also help to
reduce manufacturing costs.
In addition, modern fluid control
components and assemblies are de -
signed to provide a high degree of reliability
and availability, as well as long service
life. These criteria are especially
important when the valve must make
direct contact with media supplied to or
removed from a patient. Valve technologies
tend to incorporate inert materials,
feature low internal volumes to reduce
cross contamination, and minimize
power consumption for use in portable
equipment. Cleanroom manufacturing
capabilities additionally support the
highest level of purity for components
used in medical devices.
The MDR makes it more challenging
to comply with industry regulations and
approvals during the product development
process.
It
also
Medical Design Briefs, April 2022
increases the

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Medical Design Briefs - April 2022

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