Medical Design Briefs - April 2022 - 9

CE Markings and MDR Changes
Medical device regulations have major implications for patient care. One
recent example is the previous European regulatory framework, which failed
to prevent the use of substandard breast implants made of industrial silicone.
The MDR introduces new medical device certification procedures to
ensure that failings like these don't happen again.
Until May 2017, the European regulation for obtaining a CE marking -
which indicates that a device meets health, safety, and environmental protection
standards within the European Economic Area (EEA) - was the Medical
Device Directive (EU), including 93/42/EEC and 90/385/EEC directives for
medical devices and active implantable medical devices, respectively. In May
2017, however, the MDR replaced these regulations and instituted the following
changes:
* Implementing stricter risk assessments of existing medical devices.
* Introducing a unique product key for all medical devices.
* Instituting more stringent regulatory monitoring.
* Requiring new certificates.
* Placing greater demands on manufacturers.
expectations placed on valve technologies
and the respective manufacturers.
Some examples of compact, highly efficient
valve solutions used in medical
devices include the following:
* Miniature valves. Miniature valves that
make direct contact with media play an
important role in applications like oxygen
therapy, peritoneal dialysis, and
patient monitoring. Many individual
valves and pressure regulators are
specifically designed to minimize leakage,
reduce noise, and provide maximum
mobility in these applications.
* Engineered manifolds. Fully tailored
fluid control solutions according to
the medical device manufacturer's
individual specification allow easier
integration and reduce the assembly
process. As an example, manufacturers
of ventilators, which are critical lifesupporting
devices for many patients,
use a sophisticated combination of
proportional and miniature solenoid
valves to regulate and adjust the gas
mixture to meet patient requirements.
This valve manifold
is an engineered
solution for portable
oxygen generators.
(Credit: Emerson)
Learn More
To meet the technical requirements
for medical devices, it's important to
partner with a fluid control and pneumatics
supplier with extensive industry
experience. Companies that simply supply
components may not understand
how these components perform within
the greater system. Collaborating with a
partner that understands the complex
demands of the medical market enables
manufacturers to overcome challenges,
develop further innovations, and meet
the requirements of the MDR.
Reference
1. Regulation (EU) 2017/745, The European
Union Medical Device Regulation, 26 May
2021, https://eumdr.com.
This article was written by Thomas Beck, Global
Product Marketing Manager for Surgical and
Therapy Equipment for Emerson's Analytical and
Medical Segment, St. Louis, MO. Having worked
for a manufacturer of Class IIb medical devices
prior to joining Emerson, he is well versed in the
impact of the MDR and the role of suppliers in this
context. For more information, visit http://
info.hotims.com/82320-340.
Medical Design Briefs, April 2022
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Medical Design Briefs - April 2022

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