Standalone Software as a Medical Device

Elsmar Forum Sponsor
W

wrodnigg

#2
All - I just find an article that some of you may find to be beneficial.
Thanks for the link to the article (but to be honest, i find it much more confusing than beneficial).

I disagree with the article in many points:

I do not agree with the author regarding the "modules".
I think, he did not get the point.

First, a modular approach is not a must, but a (very) nice to have.

Second, imagine a manufacturer, which provides a Hospital Information System, which has also some functions which have to be qualified as a medical device: in this case he must qualify the whole HIS as medical device (and fulfill all the MDD requirements for the whole system). And the even bigger problem hits the operator of a hospital, which would have to operate this HIS as a medical device.

And third, following the modular approach, one can reduce the CE marking to the relevant medical device modules (there is no need to apply the MDD to any administrative function of a bigger software system).

(Yes, I am participant in a working group on this draft, and I was one of the initiators, who suggested the modular approach, since it would be of great help for manufacturers and health care facilities)

I am also not sure, if the author has read Article 2 of the MDD ("placing on the market" and "putting into service") ot the definition of these terms in the MDD, because I cannot follow his confusion:

Article 2, MDD reads:
Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose.
"Placing on the market" is defined as
the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
There is no need of a physical transfer of a device (it is the legal act of the transfer of a product to an other physical or legal person, which counts), and I do not really see a need to distinguish between physical and virtual devices.

"Putting int service"
means the stage at which a device is ready for use on the Community market for the first time for its intended purpose.
This is more or less relevant, if a medical device is put into service without placing it on the market (in case of an in-house production).

Yes, web-services are a "hot topic", but the current draft is a very toned down version (the first draft made almost every software in health care to a medical device). IN all other cases, the MDD has to be applied before placing a device on the market.

Anyone who wants to read the current draft on stand alone software classification can send me a PM (pls include your email address).

And finally I totally disagree with his "It will lead to many unhappy doctors needing to CE mark their websites"...

Yes, there are more and more of apps available in the apple or android market, which should be qualified as medical devices, but the MDD is still a requirement which has to be fulfilled by the manufacturer and not by any intermediaries.

.oO(just my 0.02 €)
 
Thread starter Similar threads Forum Replies Date
N Application of ISO 14971 to Medical Standalone Software ISO 13485:2016 - Medical Device Quality Management Systems 2
N Standalone Medical Device Software Qualification EU Medical Device Regulations 6
K Standalone software - an accessory to medical device? EU Medical Device Regulations 4
P IMDRF (International Medical Devices Regulators Forum)guidance on standalone software Medical Information Technology, Medical Software and Health Informatics 1
I CE Mark for Standalone Medical Computer Monitoring Software IEC 62304 - Medical Device Software Life Cycle Processes 5
L Regulatory Requirements for Medical Devices (Standalone-software) in Brunei Other Medical Device Regulations World-Wide 3
S Directives for Classifying Standalone Software as Medical Devices CE Marking (Conformité Européene) / CB Scheme 3
T Safety Classification in Medical Device Standalone Software IEC 62304 - Medical Device Software Life Cycle Processes 26
D Research Use Only Medical Device - Standalone software product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
P ER13.3 for standalone software CE Marking (Conformité Européene) / CB Scheme 8
K Unique Device Identifier for updates to legacy standalone software Other US Medical Device Regulations 1
D Essential Requirements Checklist for Standalone Software CE Marking (Conformité Européene) / CB Scheme 10
T FDA proposed labeling standalone software cloud based US Food and Drug Administration (FDA) 4
I DMR (Device Master Records) and similar for standalone software device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q UDI and Standalone Software - UDI per installation? Other Medical Device Related Standards 6
O Should ISO 9001:2008 be treated as a standalone quality standard alongside AS9120A? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Standalone Corrective Action Procedure or Integrated Nonconformance and Corrective Action 5
T ISO 17025 Standalone or Must Have ISO 9001 Companion ISO 17025 related Discussions 8
D ESD Quantification - Standalone instrument that can log ESD field strength ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 2
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
L Micro-Vu InSpec Software Program Qualification and Validation (including 21 CFR Part 11) 6
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 4
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C SharePoint Contract Management Software General Information Resources 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
D Safety data sheets software REACH and RoHS Conversations 2
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
S Asterisk in DOE minitab software Using Minitab Software 23
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2

Similar threads

Top Bottom