Medical Design Briefs - December 2023 - 25

transition periods until they need to present
the certificates, they should take action
immediately. The length of the individual
deadlines depends on various factors, including
prior certification in accordance
with the Medical Device Directive (MDD)
or fundamental changes in the product.
n Dual-Use Devices
Special attention should be given to
products that can be used both with and
without an intended medical purpose. A
good example are silicone implants.
They are used, for example, after a mastectomy
- surgery performed to remove
a breast, most often used to treat breast
cancer - and thus for a very clear medical
purpose. However, if an identical implant
is used for breast modification for
purely aesthetic reasons, the implant is
considered a product without an intended
medical purpose and is thus subject
to additional provisions.
With respect to certification and the
required documentation, manufacturers
may thus have to treat the same item as
two different products. While this may
appear a baffling bureaucratic obstacle
at first glance, it is actually an important
element of consumer protection for
products with a nonmedical purpose.
The MDR very clearly specifies which
documents are necessary for presenting
the safety and performance requirements
of devices with an intended medical
purpose. However, if these products
are also used for aesthetic purposes,
manufacturers must provide additional
documents that fulfill that requirement,
such as documents that furnish evidence
of the manufacturer's risk management.
If medicinal products are incorporated
in a device, they too require additional
assessment by a notified body.
n Conclusion
Neither the MDR nor Annex XVI are
new. Nevertheless, the entry into force of
the common specifications now presents
a new situation for manufacturers of devices
without an intended medical purpose.
OEMs must prove that their products
are in conformity with the MDR and
the common specifications.
This article was written by Christian
Götz, Head of Department Non-Active
Medical Devices, and Dr. Jara Brenke,
Product Specialist Non-Active Medical
Devices, TÜV SÜD Product Service
GmbH, Munich, Germany. For more
infor mation, contact dialog.medtec@
tuvsud.com or visit www.tuvsud.com.
Forging a New Path with Advances in Electro-Thermal
Design
A new electro-thermal
design process captures
accurate characteristics
from a 3D thermal
analysis.
Siemens DISW
Plano, TX
To meet the functional requirements of
a circuit under design, electronics engineers
meticulously select components,
evaluating them based on their electrical
attributes, performance benchmarks, and
rated capacities. The selected components
must all work harmoniously together to
provide the desired circuit characteristics.
To support the OEM design community,
electronic component manufacturers
have furnished models in the widely used
SPICE format. In hand, these models empower
customers to simulate their application
circuits, thereby enhancing their
comprehension of the intricacies encompassing
the capabilities, the potential,
Medical Design Briefs, December 2023
and complex interplays of these parts
within the broader system framework.
n Emerging Challenges
The dependency between component
manufacturer (the SPICE model provider)
and OEM (the SPICE model consumer)
has worked for many decades;
however, that relationship is showing significant
signs of strain.
An increasing number of traditionally
analog components are becoming more
digital - adding programmability, state
machines, and other advanced features
that are beyond the capabilities of existing
SPICE-based analog design tools.
Component manufacturers and their
OEM customers in medical electronics
increasingly battle thermal design issues
during design-in. The interactions between
electrical and thermal effects can
lead to unexpected behaviors and failures
if not properly managed. As a result,
effective electro-thermal analysis, modeling,
and design are becoming essential to
ensure that the reliable performance of
www.medicaldesignbriefs.com
n BCI-ROM: A Game-Changing
Technology
Fortunately, a game-changing technology
is revolutionizing the electro-thermal
design process. Boundary Condition Independent
Reduced Order Model (BCIROM)
captures accurate characteristics
from a 3D thermal analysis, ready for use
in a 1D circuit simulation. The BCI-ROMbased
thermal design/analysis approach
is applicable to both components and entire
PCB/enclosure and systems. BCIROMs
can simply be connected in a thermal
circuit, i.e., functional schematic,
with the heat-flow conservation principle
governing the interaction, in the identical
way Kirchhoff's Current Law (KCL)
underpins electronic circuit simulation.
This technology offers a lifeline to
electronics designers grappling with formidable
thermal obstacles driven by the
unrelenting pursuit of smaller, lighter,
25
systems in various industries. Unfortunately,
thermal SPICE has not proven to
be the answer given its many limitations.
TÜV SÜD has prepared for the anticipated
surge in demand and has provided
time slots and other resources. Nevertheless,
waiting times will be unavoidable, primarily
due to the repeated delays in approval
of
the common specifications.
Manufacturers should also make use of the
many sources of information, including
question and answer documents, official
websites, checklists and best practice
guidelines, in order to prepare for conformity
assessment as thoroughly as possible.1
Reference
1. Q&A on Transitional Provisions for Products
Without an Intended Medical Purpose Covered
by Annex XVI of the MDR, " European Commission,
September 2023, https://health.ec.europa.
eu/system/files/2023-09/md_new-reg_annexxvi_q-n-a_transition-prov.pdf.
https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf http://www.tuvsud.com http://www.medicaldesignbriefs.com
Medical Design Briefs - December 2023

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