invitro_spain
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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?
Thank you
Alberto
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?
Thank you
Alberto