Is Software an IVD Directive Classification?

invitro_spain

Involved In Discussions
Hi all!

My company has designed a software for data integration and analysis of a medical equipment files. The software has designed in relation with a Project for the diagnosis and follow-up of some human malignancies.

The software is not a part of the medical equipment. It processes the analytical results.We have defined it as a IVD product accordance to 98/79/EC Directive.

The Regulatory Department of an important customer send us an email confirmed that this is a wrongly affixed CE-IVD mark to the software regarding to the article 17 of the IVD MD Directive 98/79/EC.

I read the IVD Medical Device term and I am thinking our software complies that but when I read EDMA Position Paper "Software and IVD Directive" I begin to have many doubts about my first decision. In 2.1.1 "Software necessary for its proper application" say that "...Any software that processes the analytical result beyond that point is outside the scope of the Directive".

Can anybody help me?:nope:

Thank you

Alberto
 

Marc

Fully vaccinated are you?
Leader
Re: Software a IVD Directive Classification

Can anyone help with this one?

My Thanks in advance!
 

bio_subbu

Super Moderator
Re: Software a IVD Directive Classification

Hi all!

My company has designed a software for data integration and analysis of a medical equipment files. The software has designed in relation with a Project for the diagnosis and follow-up of some human malignancies.

The software is not a part of the medical equipment. It processes the analytical results.We have defined it as a IVD product accordance to 98/79/EC Directive.

The Regulatory Department of an important customer send us an email confirmed that this is a wrongly affixed CE-IVD mark to the software regarding to the article 17 of the IVD MD Directive 98/79/EC.

I read the IVD Medical Device term and I am thinking our software complies that but when I read EDMA Position Paper "Software and IVD Directive" I begin to have many doubts about my first decision. In 2.1.1 "Software necessary for its proper application" say that "...Any software that processes the analytical result beyond that point is outside the scope of the Directive".

Can anybody help me?:nope:

Thank you

Alberto

Dear Alberto

I would suggest you contact your notified body regarding the qualification of your product as a medical device or as an in vitro diagnostic medical device

As regards medical software, the commission's working group on Borderline and Classification, with representatives of national competent authorities, manufacturers and notified bodies are currently discussing issues related to the qualification of software as a medical device. Once consensus has been reached, the position will be reflected in the relevant guidance document which is available under the following link, stay tuned.

http ://ec .europa. eu/enterprise/sectors/medical-devices/documents/borderline/index_en.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Regards
S. Subramaniam
 
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invitro_spain

Involved In Discussions
Re: Software a IVD Directive Classification

Somebody has any experience in Software classification as Medical Devices? How I classified my software? My software analyses patient data generated by a medical device with a view to diagnosis and monitoring.

Thank you

Alberto
 

invitro_spain

Involved In Discussions
Re: Software a IVD Directive Classification

Dear Alberto

I would suggest you contact your notified body regarding the qualification of your product as a medical device or as an in vitro diagnostic medical device

As regards medical software, the commission's working group on Borderline and Classification, with representatives of national competent authorities, manufacturers and notified bodies are currently discussing issues related to the qualification of software as a medical device. Once consensus has been reached, the position will be reflected in the relevant guidance document which is available under the following link, stay tuned.

Regards
S. Subramaniam

Thank you for the information. I review MEDDEV, GHTF,EDMA and NB-MED documents but there is a lot of confusion regarding to how to regulate software.
 
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A

arios

Somebody has any experience in Software classification as Medical Devices? How I classified my software? My software analyses patient data generated by a medical device with a view to diagnosis and monitoring.

Thank you

Alberto

This is from the Annex IX of the MDD, not the IVDD:

"2.3. Software, which drives a device or influences the use of a device, falls
automatically in the same class."

I hope it is the same approach for IVDD's
 

bio_subbu

Super Moderator
Re: Software a IVD Directive Classification

Thank you for the information. I review MEDDEV, GHTF,EDMA and NB-MED documents but there is a lot of confusion regarding to how to regulate software.

Hi Alberto

The EDMA is an industry position paper, and not the view of the EU authorities, so this is certainly not authoritative guidance. Certain types of medical software are covered by the amended rules as per the directive 2007/47/EC. The applicable medical devices and accessories thereto are defined in Article 1, paragraph 2(a) of both the MDD and the AIMDD. As per the amendments, medical devices are defined as:

“any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings”

Software is considered to be stand-alone or accessory, and, therefore, a medical device and covered by the new rules. Since your medical software is used for “analysis of patient data generated by a medical device, with a view towards diagnosis and monitoring” your product must be CE-marked in its own right and must undergo conformity assessment as such. Refer annex IX of MDD classification rules, for decide whether your software qualifies as a medical device.

S. Subramaniam
 

xcanals_tecno-med.es

Involved In Discussions
Re: Software a IVD Directive Classification

Dear Alberto
in order to review your classification you must provide the rational for the current classification.
Follow the following steps:
1. The classification must start with the intended use of your product. Please provide
If the product is not in the annex II (list A or B) and is not for self-testing you can not ask for the help of a notified body but from the Health Authorities

At this point you must review the guidelines documents on software which are in process of change (as Mr Subramainam stated)
you may see the current software guideline:

http://www.meddev.info/_documents/R2_2-4_rev5.pdf

which states:

"...
Software is regarded as a medical device when one or more of the
circumstances given at (a) to (d) apply:
...
(c) The software is intended for the analysis of patient data generated by a
medical device with a view to diagnosis and monitoring4.
Example 4: for analysis of stored long duration cardiac signal from a Holter ECG.
Example 5: for diagnostic image processing.
Example 6: for correlating or physical measurements or signals to clinical or analytical results such as for IVD instruments.
Example 7: for calculating, estimating, modelling or predicting surgical placements or dosimetry regimes.
Example 8: long term comparative monitoring of stored images for oncological diagnosis.
Example 9: software for the measurement/calculation of anatomical sites of the body with a view of an irradiation or surgical intervention
... "

Regards
:2cents:

Xavier
 

chris1price

Trusted Information Resource
Re: Software a IVD Directive Classification

Hi

Having recently had to remove CE Marks from our products, I would agree with the comment above. Talk to your Competent Authority, not the Notified Body. At the end of the day, the CA makes the decisions on whether your product is covered by the directive and its classification. The NB will only rubberstamp their decision.

Chris
 

xcanals_tecno-med.es

Involved In Discussions
Dear all

only an additional comment (made by my associate Claire Murphy) relative to the classification of IVD software,

at this moment, and pending of the new edition of the classification guidelines, due to the current definitions only the reagents are classified as list A or B of annex II

for example:
"...
— Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,
..."
note that the term "software" not appears in the definition
and for the software for trisomy 21:
"...
— reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21,
..."

so for example a software which is provided associated in the determination of a blood group kit (which is an IVD of list A annex II - needs the evaluation of a Notified Body- is CE marked with the notified body number) is classified as "rest of products" (= not list annex II, nor self-test) and according this classification don't need the evaluation of a Notified Body (is CE marked without any notified body number)

Regards
 
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