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Hello,
Since this is my first post here I will introduce myself briefly.
I am working for a company that has been marketing dental equipment in the Netherlands for almost 20 years. I have been working for this company for almost a year now. I am a lawyer by training, but I have no specific knowledge of application of standards, methods etc. relating to medical devices.
At the moment we are working on the development of a new product line. At first we will be exclusively marketing the new product to the European market. (mainly BeNeLux, Nordic countries and Germany).
The product is a Dental Treatment Unit, sometimes referred to a dentist's chair (although the actual chair in which the patient sits is not included in our product!)
My first priority is to work out what are the technical and procedural requirements that apply to our product category, to which we have to comply to be able to put the product on the market in the first place. Also, a reasonable level of protection from claims is desirable.
The main problem that I have is that it is not clear to me where I can find an overview of the requirements we have to fulfil. The information I have found so far has been detailed enough, but I have no idea what is actually important to me and what isn't.
I have worked out that the product can probably be classified as a Medical Device, Class I according to the European Medical Devices Directive (93/42/EEG:2007)
It seems that the procedure to be able to put the CE mark on it is pretty straightforward and does not require auditing, etc. But perhaps there is more to it.
What steps should I take next? Am I missing important stuff that might interfere with market introduction?
If you need more info, examples or anything, please let me know.
Thanks In Advance!
Since this is my first post here I will introduce myself briefly.
I am working for a company that has been marketing dental equipment in the Netherlands for almost 20 years. I have been working for this company for almost a year now. I am a lawyer by training, but I have no specific knowledge of application of standards, methods etc. relating to medical devices.
At the moment we are working on the development of a new product line. At first we will be exclusively marketing the new product to the European market. (mainly BeNeLux, Nordic countries and Germany).
The product is a Dental Treatment Unit, sometimes referred to a dentist's chair (although the actual chair in which the patient sits is not included in our product!)
My first priority is to work out what are the technical and procedural requirements that apply to our product category, to which we have to comply to be able to put the product on the market in the first place. Also, a reasonable level of protection from claims is desirable.
The main problem that I have is that it is not clear to me where I can find an overview of the requirements we have to fulfil. The information I have found so far has been detailed enough, but I have no idea what is actually important to me and what isn't.
I have worked out that the product can probably be classified as a Medical Device, Class I according to the European Medical Devices Directive (93/42/EEG:2007)
It seems that the procedure to be able to put the CE mark on it is pretty straightforward and does not require auditing, etc. But perhaps there is more to it.
What steps should I take next? Am I missing important stuff that might interfere with market introduction?
If you need more info, examples or anything, please let me know.
Thanks In Advance!
Us mortals are not that privileged!...