MEDDEV: Qualification and Classification of Stand Alone Software Published

W

wrodnigg

#1
The final version of the Guidelines on the Qualification and Classification of standalone software used in healthcare within the regulatory framework of medical devices has been finally published (earlier than expected)

The document can be downloaded here (.pdf)

I think it is a good guideline. It will be of help to reduce the big confusion which was triggered two years ago by people without sufficient experience in this topic.

And the most important content is the clarification, that the decision is always up to the legal manufacturer.
 
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thisby_

Involved In Discussions
#2
Hello,

I read it, and is a major breakthrough however it is not clear on weather medical devices for connectivity, the so called MDDS in the US, should be considered or not a medical device. Does the transformation of raw data in HL7 makes the device a medical device?
What do you think? Thank you in advance!

Cheers,
Emilia
 

c.mitch

Quite Involved in Discussions
#3
Hello thisby,

I read the meddev carefully. This document with its decision trees and numerous examples is a great step forward. The section 4 about heterogeneous systems, which integrate medical devices modules, is a new approach I've never seen before.


IMHO, according to the decision tree in figure 1, MDDS decision path falls into question 5. They are qualified or not as medical devices by their intended use. Are they for diagnosis or therapeutic purposes?

I tend to think that MDDS are not medical devices, given the examples in annex 1: pre-hospital ECG systems are not MD, neither CIS and PDMS.



Regards.

Mitch.
 
W

wrodnigg

#4
At first: the decision is up to the manufacturer.

As I read the FDA definition:

Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring.
It depends on the detailled functions of the system, but in general a MDDS would not be a medical device (but it is definitiely borderline).

Look at the borderline manual Version 1.11 (12-2011) according PACS ()p.34):
However, PACS that are only intended for archiving or storage of data may not fall within the definition of a medical device provided that data is not manipulated.
p.s.: Yes, I am glad that the modular approach made it.
 

thisby_

Involved In Discussions
#5
Besides the fact that is up to the manufacturer and has to do with the intended use, which is the case for every MD whether in Europe or in the US, in the definition is lacking the concept of "convert formats" that is explicitly described in the MDDS definition from FDA.
If a manufacturer does a device for transmission/connectivity of data and the "translation" of those data in different protocols is it or is not a medical device?

Your example from the border line manual regarding the PACS that only archive images, in the same format the medical device (TAC, MRI) sends them, without making any change is not a medical device. However if the images were not sent in DICOM format and the PACS besides archiving them would "translate" them into DICOM format and then send them to a visualization system (e.g. EMR), would it be a medical device or not?

In my opinion it should be.
I think it is important to keep these kind of devices under the MD rules because they may be in an important chain of communication in the hospital. (of course a manufacturer could always follow the MD standards even if the device is a border line not exactly a medical device, but we don't live in a perfect world and it would be too expensive for a manufacturer to do it for no reason or any added value).
 
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