For software change - New Channel of interoperability

#1
Dear all,

As the application date is coming closer and closer, I was reading the MDCG guidance related to substantial changes according to article 120 of the MDR.

For software change, it is mentioned that a new channel of interoperability is considered a substantial change.
Can someone here elaborate on what is considered a new channel of interoperability? Is it the implementation of a new standard (HL7, DICOM)? Or a new/updated API based on an already implemented standard is also substantial?

Thanks to anyone that can participate in this thread.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I did a couple of quick searches but didn't find anything. Can you post the URL (you may not be able to post the link so you may have to chop it up a bit).
 
#3
Dear Yodon,

Thank you for your reply.
The MDCG guidance is called: MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.
The link is the following: ec.europa.eu/docsroom/documents/40301/attachments/1/translations/en/renditions/native
And the mention of the "new channel of interoperability" is on page 10, in chart C.

I hope this helps.
Best.
 

yodon

Staff member
Super Moderator
#4
It does help, thank you! But I'm in the same boat with you now, not really knowing what they mean! My original thought was that it was maybe changing from, say, wired to wireless communications or maybe even to a different type of wireless (e.g., BLE to WiFi) but that would involve hardware so I don't think that's the intent. I think your initial thoughts are correct but could be both a new standard or a new/modified API.

Hopefully others will weigh in and have a more concrete answer.
 
#5
Dear Yodon,
Thank you for taking the time to look into it and provide your feedback.
Now let's hope that someone can shed the light on this mystery.
 

pmg76

Starting to get Involved
#6
We are also trying to understand this meaning...

In this link: www.fda.gov/medical-devices/digital-health-center-excellence/medical-device-interoperability
it says: "Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems."

With this in mind, I would expect that: to support a new protocol (e.g.: HL7), to add new type of information to an existing protocol (e.g.: add transmission of alarm information), or things like that; would mean a "new channel of interoperability".
I would say that updating information to an existing protocol API (e.g.: add a new measurement to the packet of measurements that the protocol was already sending) would not be considered a new channel of interoperability.

Hope someone who has a more clear understanding of this concept can share the correct explanation.
 
Thread starter Similar threads Forum Replies Date
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
R Software change control process and defect tracking ISO 13485:2016 - Medical Device Quality Management Systems 1
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
J PMA Device - Lot # change in New ERP Software - What are the FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A Software Suggestions for Engineering Change/QMS Design and Development of Products and Processes 2
E Special 510(k) for software change Other US Medical Device Regulations 1
S Software Application for Management of Change (API 5.11) Other ISO and International Standards and European Regulations 3
T Class II Medical Device with Software - Change to Computer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Change Control Forms Post Software Validation Medical Information Technology, Medical Software and Health Informatics 2
K Change Control for Software System that Controls Aspects of GMP Quality Assurance and Compliance Software Tools and Solutions 5
E Help with ECR/DCR Document Change Control Software Validation Qualification and Validation (including 21 CFR Part 11) 6
D Question surrounding Special 510(k) in regards to Software Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
L Engineering Change Control Software Systems - Recommendations? Document Control Systems, Procedures, Forms and Templates 2
R PMA (Parts Manufacturing Approval) Supplement - Labeling Software Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Management Of Change System or Software - Recommendations and Ideas wanted After Work and Weekend Discussion Topics 2
J Looking for a change template related to software change? Document Control Systems, Procedures, Forms and Templates 2
K Software Device "Urgent" Releases? Software Change Control Process IEC 62304 - Medical Device Software Life Cycle Processes 9
A Design Review OR Design Change - Software development company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
W When to change UCL and LCL - SPC Software Statistical Analysis Tools, Techniques and SPC 4
U Advice on Engineering Change Request (ECR) software Software Quality Assurance 4
Q Global change software where changing one document changes all documents Quality Assurance and Compliance Software Tools and Solutions 1
M Using M-1 Software for Quality - Manual Engineering Change Order Entry Quality Assurance and Compliance Software Tools and Solutions 1
D What constitutes a "significant change" in software AND what does not Software Quality Assurance 7
J Software change control - How should I be controlling software changes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Enterprise change management control system software - Medical Devices Quality Assurance and Compliance Software Tools and Solutions 0
G PEDYN (Professional Engineering DYNamics) Change Mangement Software Quality Assurance and Compliance Software Tools and Solutions 4
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
J EU equivalent to Clinical Decision Support Software EU Medical Device Regulations 3
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 12
S Recommended software to send Quality scorecards to suppliers (external providers) Supplier Quality Assurance and other Supplier Issues 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
BeaBea QMS/ Training Management Software Service Industry Specific Topics 4
shimonv Working with a software developer who is not setup for IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
Q Gage calibration / tracking software General Measurement Device and Calibration Topics 5
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Y RT-qPCR Software result EU Medical Device Regulations 0
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
F WANTED Senior Software engineer Career and Occupation Discussions 2
P Blood establishment computer software EU classification EU Medical Device Regulations 0
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
D Integrated Management System Software Quality Manager and Management Related Issues 2
B Sampling strategies/techniques for software QA Software Quality Assurance 2
K MDCG-2020-3 (about the software of UI) EU Medical Device Regulations 3
D PFMEA Software search IATF 16949 - Automotive Quality Systems Standard 7
C MDR software classification EU Medical Device Regulations 12
H Class II a vs "software safety class A" IEC 62304 - Medical Device Software Life Cycle Processes 3

Similar threads

Top Bottom