Software Medical Device Classification

N

nellooo

#1
Dear experts,
I'm trying to find a criterion for the classification of Software Medical Device, to implement management procedures (test and maintenance).
In addition to the classical classification in relation to the risk class (Class I, IIa,IIb,III in Europe, and Class A,B,C in USA) does anyone have other references or personal ideas to catalog SW MD?
Thanks in advance for any feedback.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
IEC 63204 has class A, B, C as well.

In the US, the FDA has a "level of concern" rating: Minor, Moderate, and Major.
 
N

nellooo

#3
Thanks for feedback. I asked for a different criterion of classification in addition to classical classification related to risk.
For example: functional classification, morphological classification, software connected or disconnected to the network....
 
#5
Rules and Regulations for Medical Device Update

Medical updates are necessary for a number of reasons. A healthcare setting has to keep giving medical updates to the families of patients that it is treating. A medical update becomes very important for the media when an important person is undergoing treatment. Medical updates are also given out on social media whenever something significant is noticed or discovered that could be of use to society at large.
 
#6
The effect of software on the safety and performance of medical devices has continued to grow over recent years. This is particularly relevant when the device itself is a software only product.
As a Notified Body, we have world-leading product specialists in the Active Devices, IVD and Active Implantable Medical Devices teams with a wealth of experience gained from device and other regulated industries to understand the complete range of medical device software

Is my Software a Medical Device?

The first stage is to confirm your product or service is legally classified a Software as a Medical Device (SaMD); the product must first have a stated intended purpose that is medical as defined by the medical Directives. It is sometimes difficult to determine if your software or part (modules) of the software has a medical purpose (borderline purposes); for more information you should consult MEDDEV 2.1/6. If software is an accessory to a medical device, MEDDEV 2.1/6 states, “if the software is an accessory to a medical device, it is not a medical device, but it falls under the MDD 93/42/ EEC.”
As indicated in the MDD, standalone software which has a medical purpose is considered to be an active medical device. Classification depends on the risk to the patient and users. To classify your software fully you will need to review rules 9, 10, 11 and 12 of Annex IX of the MDD and also Annex IX, 2.3: Software which drives a device or influences the use of a device, falls automatically in the same device class.
If you are unsure regarding classification, please come and talk with BSI. The European Commission's guidance MEDDEV 2.1/6 is only applicable to standalone software which it defines as: “Software which is not incorporated in a medical device at the time of its placing on the market or its making available.”
AIMD and IVD Directives
Standalone software shall be classed as an AIMD/ IVD or an accessory to an AIMD/ IVD provided that it meets the definition contained in the relevant Directive.
 
Thread starter Similar threads Forum Replies Date
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 1
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) 1
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 6
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
V Software medical device labelling EU Medical Device Regulations 5
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
H ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device) ISO 14971 - Medical Device Risk Management 1
T Are internally found Medical Device Software "Bugs" Complaints? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K 510k "Premarket" Submission for Existing Class II Software Medical Device US Food and Drug Administration (FDA) 3
P UDI Registration - Class II Medical Device Software Other US Medical Device Regulations 9
D Medical Device Software Tool Validation - Compilers! IEC 62304 - Medical Device Software Life Cycle Processes 7
N When is Medical Device Software Validation required? ISO 13485:2016 - Medical Device Quality Management Systems 6
Similar threads


















































Top Bottom