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Where can I find a list of CE Approved Products?

S

SmallD

#1
I have used the FDA search facility to locate products having a 510(k) to see their class and would like to find the same for CE marked products.
Where can I find a list of CE approved products?
 
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chris1price

Trusted Information Resource
#2
Sorry, your out of luck. There has been talk for many years of a database for CE Marked devices, but it is not yet in place. A few notified bodies do list products or companies that they have certified, but this is comparatively rare.

Does anyone know the latest on the MDD database?

Chris
 
S

SmallD

#3
Thanks Chris, I pretty much knew the answer but was still hoping something may exist.
The problem is we have "medical devices" that are class IIa, need clinical evaluation reports but are devices that are accessories to other real medical devices, making them classed as "medical". I am having a very hard time finding equivalent devices.
 
A

Aliasanonymous

#4
Hi,

Just to check for updates on the availability of such a list.
I know there's the EUDAMED, but it's not publicly accessible. Anybody know of a publicly accessible list? Or anyway to find out if a certain manufacturer's product has the CE mark, other then asking for the certificate or more obvious ways?

Thanks.
 

pkost

Trusted Information Resource
#5
EUDAMED as it currently stands is for CA's; it is not publically accessible (in fact the MDD treats the information as confidential). The proposed regulation includes text for EUDAMED mkII which will be publically accessible and be a complete list of all medical devices on the EU market, unfortunately the proposed text won't come into force until ~2018/2019

In order to check whether a manufacturer has a CE mark then if it is subject to notified body review you can and should request the CE certificate from the manufacturer. Once you receive that if you want to close the loop ring up the notified body and ask to confirm the scope of the certificate and whether it is valid - just give them the certificate number....Not the most efficient way, but it works

For Class I products just ask for a DoC, as self declared compliance is all that is necessary.

Some individual member states list manufacturers that have notified them of their intention to market Class I products - the MHRA breaks this down into broad product groups
 
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