Software medical device labelling

V

vbosq

#1
Hello,

I try to find what info is mandatory on the label of software as a medical device/accesory to a medical device. What are the reguirements for EU and FDA?
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#3
Have a look at:
ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements. This standard is recognized by the EU and FDA.

EN 1041:2008
Information supplied by the manufacturer of medical devices
This standard is applicable to the EU market.

You can also look at labels for similar products online.

Goodluck,
Shimon
 

akp060

Involved In Discussions
#5
Hi,
there is one earlier GHTF report on labeling that I would propose:
http://www.imdrf.org/docs/ghtf/fina...el-instruction-use-medical-devices-110916.pdf

There are also requirements for UDI (Unique Device Identification) to look into.

Software does not really differ for labellig from non-software devices.

Hope this helps
Regards
Szabolcs
Hi,
I was viewing this post while seeking somewhat related answers.

Would like to identify that N70 is superseded by N52, link below, hope it helps members who would view this thread in future
http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-labeling-md-ivd-n52-180712.pdf

T.Y.
 

Attachments

akp060

Involved In Discussions
#6
Adding to what has been said by respected members above, the requirements of EU are covered in BS EN 1041:2008+A1:2013 , and that of FDA in
21 CFR 807.87 (e) . Now the interpretation of these are very simple (please read N52 also, for a bit more clarity, with focus on Fig 1; the definitions 3.9; 3.10; 3.15; 3.17; 3.19; 3.20). Any information that hints at these requirements or lets say which the EU or FDA may leverage w.r.t to these points are the requirements.

What it means is, the manufacturer has to carefully analyze what you are displaying to the users or patient. For a SaMD it could be as simple as an advisory statement on the homepage (if a web application) or the default message printed on the generated reports, to as complicated as a specific way of configuration/ remedy, the information about which is provided on an User Manual. Thats it... not complicated at all but as tricky as it can get
 
Thread starter Similar threads Forum Replies Date
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 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
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 3
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
Z Software Library - could it be a medical device? ISO 13485:2016 - Medical Device Quality Management Systems 5
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
D Requirements for the dimensions / color of medical device labels - Software as a Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 2
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
R Medical device software without user interface Other Medical Device and Orthopedic Related Topics 3
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
Ed Panek Rule 11 Question - CE approvals for software as well as the medical device EU Medical Device Regulations 7
D IEC 60601 for a Software only Medical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
S Medical Device Software Distribution for a CE-marked medical device via a USB memory stick EU Medical Device Regulations 8
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
P Software requirement and design specifications - Medical device contains both hardware and software IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational TGA Consultation: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
N Medical Device Accessory Classification - Software as a Medical Device Other Medical Device Regulations World-Wide 5
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
M Medical Device News TGA – Regulation of Software as a Medical Device Medical Device and FDA Regulations and Standards News 0
S Two Questions about Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Medical Device Software Update in Field of AIMD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
R Online / Cloud Based Software as Medical Device EU Medical Device Regulations 8
S DMR (Device Master Record) for Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 3
S Labelling in Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 8
S What is considered the complete software medical device? Medical Information Technology, Medical Software and Health Informatics 6
JoCam Medical Device Software - Apps which can control medical devices EU Medical Device Regulations 13
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
A SOP for software validation of software in medical device IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
K Registering a Software medical device (SaMD) in China China Medical Device Regulations 5
N Medical Device Software - Switch from Waterfall to Agile methodology Medical Information Technology, Medical Software and Health Informatics 4
I Medical Device Software Risk Analysis ISO 14971 - Medical Device Risk Management 4
S If a piece of software receives approval as part of a medical device system Canada Medical Device Regulations 5
C Controlling Software Versions that are part of a medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
S Cloud-Based Stand Alone Software - Software Medical Device (Class II) US Food and Drug Administration (FDA) 2
Q QMS Software for Startup Medical Device Company Other Medical Device and Orthopedic Related Topics 7
B CQC oversight of Medical device software? EU Medical Device Regulations 3
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
B Is IEC TR 80002-1:2009 applicable to stand-alone medical device software? ISO 14971 - Medical Device Risk Management 1

Similar threads

Top Bottom