SaMD Regulations

Difference Between the FDA’s and EU’s

Regulatory Approach
Requirements & Timeline

PARUL CHANSORIA
IMDRF Defining SaMD
The International Medical Device Regulators Forum (IMDRF) defines
SaMD as “software intended to be used for one or more medical
purposes that perform these purposes without being part of a
hardware medical device”.

Key Notes:

SaMD is a medical device and includes in-vitro diagnostic

medical devices
SaMD can run on general purpose (non-medical) computing
platforms
Software is not SaMD if its intended purpose is to drive a
hardware medical device
SaMD may be used in combination with other products—
including medical devices
SaMD may interface to other medical devices, including
hardware medical devices, other SaMD software, and general
purpose software
Mobile apps that meet the definition are considered SaMD
SaMD US vs EU
SaMD Classification

USA’s Take on SaMD

Classification
EU’s Take on SaMD Definition: SaMD is defined as a
Classification software intended to be used for
one or more medical purposes that
EU doesn’t use the term SaMD.
perform these purposes without
Instead, they use “medical device
being part of a hardware medical
software” or “MDSW.”
device."

Definition: It is defined as software

FDA classifies medical devices as
that is intended to be used, alone or
Class I, II, and III.
in combination, for a purpose as
specified in the definition of
You can classify a device by
‘medical device’ in the MDR or IVDR.
looking through databases to find
an applicable product code and
EU classifies medical device as per
matching device class.
MDR into Class I, IIa, IIb, and III and
IVDR classifies into Class A, B, C, and
Note: Things become a lot harder, if
D.
there’s no code.

For EU you have to use a rules-based

framework to classify medical device

For SaMD, there are 22 rules that

must be addressed to get a
classification output. Additionally,
one needs to consider IEC 62304.
SaMD US vs EU
Regulatory Approval Process

USA’s SaMD Regulatory EU’s SaMD Regulatory

Pathway Pathway

Conformity Assessment: SaMD

510(k) Clearance: SaMD may be
must undergo a conformity
eligible for 510(k) clearance if it is
assessment procedure based on
substantially equivalent to a
the risk classification.
legally marketed device.
Notified Body Involvement:
De Novo Classification: SaMD
Higher risk SaMDs require
that does not have a predicate
involvement of a notified body
device can apply for De Novo
for assessment.
classification, which establishes a
new regulatory classification.
Pre-market Approval (PMA):
Some SaMD may require PMA,
especially if they are high-risk or
do not fit into the 510(k) or De
Novo pathways.
SaMD US vs EU
Documentation

EU’s SaMD Documentation

USA’s SaMD Documentation Comprehensive documentation is

FDA typically requires detailed
documentation including:
- Software description
- Hazard analysis
- Software architecture
- Verification and validation
- Clinical evaluation
- Labeling
- Iinstructions for use.
required, including:
- Clinical evaluation
- Risk management
documentation
- Technical documentation
- Post-market surveillance plan
Note: SaMD must have a Unique
Device Identifier under the MDR,
allowing for better traceability.

Note: Compliance with QSR (21

CFR Part 820) is required for
SaMD manufacturers, ensuring
that devices are produced in a
safe and effective manner.
SaMD US vs EU
Which One Is Less Time Consuming?
EU’s SaMD Documentation
USA’s SaMD Documentation
Timeline: The FDA typically
provides specific review
timelines for different pathways
(e.g., 90 days for 510(k)
clearance, longer for PMA).
Predictability: The FDA's review
process is generally more
predictable, with established
timelines and processes for
each pathway.
Potential Delays: FDA review
times can vary based on the
complexity of the submission,
the need for additional
information or clarification, and
the workload of the reviewing
division.
Transition Period: As of the
implementation of the MDR in May
2021, there are some uncertainties
or delays as the industry is adapting
to the new regulations.
Notified Body Involvement:
Involvement of a notified body for
higher-risk devices adds an extra
layer of review, extending the time
to market.
Documentation Requirements:
The MDR mandates comprehensive
technical documentation, clinical
evidence, and post-market
surveillance plans, which require
additional time to compile and
review.
SaMD US vs EU
Which One Is Less Time Consuming?
Conclusion

EU MDR process can be slightly more time-consuming

(depending on the device classification) due to factors such as
the involvement of notified bodies and the comprehensive
documentation requirements than that of the US FDA.
 BY
PARUL CHANSORIA
Founder,
Elexes Medical Consulting

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