Dear Forum,

first to clarify...although similar to, this post is not equal to the post I made a few days ago...:cool:
-----

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.?

:nopity:

temu

You don't manufacture the gel and you don't include any with your equipment when you sell it, correct? All you do is recommend gels? The buyer of your equipment buys the gels directly from the manufacturer, correct?

You don't manufacture the gel and you don't include any with your equipment when you sell it, correct? All you do is recommend gels? The buyer of your equipment buys the gels directly from the manufacturer, correct?

Yup, that is correct.

Problem is that there are not many of these gels on the marked, so the least we can do is to recommend what to use.

temu

* 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?
No, but competent respectable companies shouldn't mind sharing that information. On the contrary, you may help them sell more products if you endorse a specific brand.... BUT, ultrasound is a tricky one, and almost every other hospital has their specific brand that they will only use ;)


*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) I don't see why not, legally speaking... But financially, you don't want to go there and waste your own money, why should you??


*Does anyone have any suggestions as to how I can proceed.?

If I were you, I would not recommend a specific brand. Doctors at hospitals have specialist knowledge and they have preferred suppliers, in the long run you may help some other company sell a bit more, but it is not your company. I would simply advise the users to use a sterile gel that were accepted for use in theater. :bigwave: