Medical device (sonic scaler): experience with 84/539/EEC Directive

I

instorer

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
 
G

Gert Sorensen

Re: Medical device called skaler: experience with 84/539/EEC Directive

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

Leader
Admin
Re: Medical device called skaler: experience with 84/539/EEC Directive

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.
 
G

Gert Sorensen

Re: Medical device called skaler: experience with 84/539/EEC Directive

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.
 
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