instorer
10th July 2007, 10:50 AM
Hi Everybody
Does anybody has experience with putting on EU market medical device for veterinary purposes?
I would like to enter the EU market with skaler - medical device using in getting ride of scale using ultrasound. I have read 84/539/EEC directive and all accompaning documents. My doubt is if I need any opinion of notified body (any technical, design or medical test) or can I prepare all documentation by myself (as for medical devices class I according to MDD).
I would be grateful for any comments.
Kind regards
Michael
Gert Sorensen
11th July 2007, 02:28 AM
Hi Everybody
Does anybody has experience with putting on EU market medical device for veterinary purposes?
I would like to enter the EU market with skaler - medical device using in getting ride of scale using ultrasound. I have read 84/539/EEC directive and all accompaning documents. My doubt is if I need any opinion of notified body (any technical, design or medical test) or can I prepare all documentation by myself (as for medical devices class I according to MDD).
I would be grateful for any comments.
Kind regards
Michael
Anybody here at the Cove who has veterinary experience?
Jim Wynne
11th July 2007, 12:23 PM
Anybody here at the Cove who has veterinary experience?
The device in question is an ultrasound scaler (not skaler) that's used to remove dental plaque, and as far as I know, the devices used in veterinary applications are no different from those used by dental hygienists on humans. The question is, what are the EU requirements for veterinary medical devices? I don't know, and didn't have much luck Googling, but I suspect that if the devices meet the requirements for human applications, they'll also be OK for veterinary purposes.
Gert Sorensen
12th July 2007, 02:26 AM
Hi Everybody
Does anybody has experience with putting on EU market medical device for veterinary purposes?
Does not seem like it :D
I would like to enter the EU market with skaler - medical device using in getting ride of scale using ultrasound. I have read 84/539/EEC directive and all accompaning documents.
Now I have read the directive too, that makes two of us:)
My doubt is if I need any opinion of notified body (any technical, design or medical test) or can I prepare all documentation by myself (as for medical devices class I according to MDD).
Given that it is regulated by an EU-directive then the product should be CE-marked. This means that you should follow the normal directions to obtaining a CE-mark for the products. You make need to get acquainted with EN61010, Machine safety.
