T
Dear Forum,
first to clarify...although similar to, this post is not equal to the post I made a few days ago...
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Developing ultrasound equipment + probes for use directly on the heart during heart surgery, we depend on ultrasound gels made from other companies.
As the gel is placed directly on the surface of the heart we need it to meet the criterias of biocompatibility.
However, we do not get a certificate assuring biocompatibility from the manufacturer of the gel. Although the "Material Safety Data Sheet" does not specify any hazardous material, we would prefer to have a certificate of biocompatibility.
I guess if the company does not market their gel as "biocompatible" they do not need to have these certificates. However, on the company´s website I can find no information regarding instructions for use, intended use etc.
* If I contact the European distributor, am I in any position to "demand" any information that should be mandatory according to MDD? (like intended purpose, IFU etc?
*Unless the manufacturer can provide certificates of biocompatibility, are we allowed to test the products ourselves? (of course, then we will have the same problem once the manufacturer changes the composition/procedures etc)
*Does anyone have any suggestions as to how I can proceed.?

temu
first to clarify...although similar to, this post is not equal to the post I made a few days ago...
-----
Developing ultrasound equipment + probes for use directly on the heart during heart surgery, we depend on ultrasound gels made from other companies.
As the gel is placed directly on the surface of the heart we need it to meet the criterias of biocompatibility.
However, we do not get a certificate assuring biocompatibility from the manufacturer of the gel. Although the "Material Safety Data Sheet" does not specify any hazardous material, we would prefer to have a certificate of biocompatibility.
I guess if the company does not market their gel as "biocompatible" they do not need to have these certificates. However, on the company´s website I can find no information regarding instructions for use, intended use etc.
* If I contact the European distributor, am I in any position to "demand" any information that should be mandatory according to MDD? (like intended purpose, IFU etc?
*Unless the manufacturer can provide certificates of biocompatibility, are we allowed to test the products ourselves? (of course, then we will have the same problem once the manufacturer changes the composition/procedures etc)
*Does anyone have any suggestions as to how I can proceed.?

temu
