Listing of Similar Medical Devices approved by CE NB

[w_grunfeld]

Where can I find a listing of Class III CE marked medical devices? or a listing per product type?

 

[edgar123]

Re: Similar Medical Devices approved by CE NB

Hi Willy,

There is the link to the MEDDEV document for the classification of medical device on the EU web-page. I've attached the file.


For each rule if class III products are included, an example list will be given.

 

[MIREGMGR]

Where can I find a listing of Class III CE marked medical devices? or a listing per product type?

I'm not aware that such a master list exists in a public form.

 

[w_grunfeld]

Re: Similar Medical Devices approved by CE NB

Hi Willy,

There is the link to the MEDDEV document for the classification of medical device on the EU web-page. I've attached the file.


For each rule if class III products are included, an example list will be given.

Thanks Edgar, I have the Classification Guide but it doesn't answer my question.
I meant a listing of actual products (names) on the EU market. I have applied to a European NB for a quote and they answered that in order to provide a quote they need info on the candidate product. Among other hings they want a list of similar products alrady approved

 

[w_grunfeld]

I am afraid you are right....

 

[edgar123]

Sorry for my misinterpretation.

Yes in fact this information is not accessible to public.
Currently EUDAMED is a database contains this information but only competent authorities have access to as mentioned on the European Union website.

The NB you applied to might have a better chance to get this information...

 

[Sarah Stec]

Re: Similar Medical Devices approved by CE NB

Getting information about the device in order to build a quote is pretty normal - there are a lot of factors that can come into play and some can make a pretty big difference in terms of pricing.

For similar products already on the market, most manufacturers that I've seen have found this information through their market research.