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
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