Is there an Official Website for Medical Device Registration Information

L

LearnMo

#1
hi,all

how can I know a medical device sold in Europe is approved/authorized ?Is there any official website for consulting the registration info of the device and its manufacturer?

access to medical device info is urgently needed to me,thanks a lot in advanced for any response to the question.
 
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Marc

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#2
Does anyone have any information they can share with regard to any official website for confirming the registration information of medical devices and their manufacturer?
 
M

MIREGMGR

#3
There is no such site.

The CE mark on a medical device's labeling indicates that the product is duly authorized and the manufacturer is appropriately certified.

If a medical device is CE marked and there is some question about the legitimacy of that marking, it makes sense to begin with the device's maker. If your inquiry is civil and coherent, they will respond informatively regarding their regulatory stance.

Failing that, if the CE mark incorporates the identifying number of a Notified Body, you can inquire to that organization as to the product. If there is a problem, they will want to straighten it out.

Class I (non-sterile, non-measuring) devices are self-certified and don't carry a Notified Body identification, of course. For such a product, it may be challenging to figure out who to contact other than the maker. Sometimes a company's website will include their regulatory certificates, from which the Notified Body with which they work can be identified.

Of course, if your goal is to learn competitive information rather than to address regulatory concerns, none of these paths is likely to do much good. No one is obligated to provide product information to competitors, within the EC device regulatory system.
 
Y

yana prus

#4
The reason there is no such site, is as mentioned MIREGMGR, because of EC device regulatory system - Article 20 of MDD 93/42/EEC which maintained that all information available under the Directive is confidential. That's why you can see in some websites of NBs the ISO 13485 certificates, but not the certificates issued under MDD 93/42/EEC.
(BTW, Under the revised MDD (Article 20) confidentiality is no longer requested for: information in and about certificates, registrations of persons responsible, information to users in case of an incident).

As MIREGMGR suggested, some companies publish the CE certificates in their website. In the case you cannot find the certificates, you can look for other documents that usually bear the CE Mark like: product specification/datasheet (there maybe a paragraph for regulatory approvals/clearances), marketing materials, user manual, etc.
 
L

LearnMo

#5
The reason there is no such site, is as mentioned MIREGMGR, because of EC device regulatory system - Article 20 of MDD 93/42/EEC which maintained that all information available under the Directive is confidential. That's why you can see in some websites of NBs the ISO 13485 certificates, but not the certificates issued under MDD 93/42/EEC.
(BTW, Under the revised MDD (Article 20) confidentiality is no longer requested for: information in and about certificates, registrations of persons responsible, information to users in case of an incident).

As MIREGMGR suggested, some companies publish the CE certificates in their website. In the case you cannot find the certificates, you can look for other documents that usually bear the CE Mark like: product specification/datasheet (there maybe a paragraph for regulatory approvals/clearances), marketing materials, user manual, etc.
But why in USA,registration info of the device is accessible on FDA website,is that because of the different device regulatory system ?!
 

xcanals_tecno-med.es

Involved In Discussions
#8
Note that the database is still defined and will be operative on 1st may 2011, see the EU decission which establishes the European databank for medical devices EUDAMED

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:102:0045:0048:EN:pDF

The information which will be available in the database is also defined:
1. Actor (manufacturer/authorised representative): (a) Name; (b) Street; (c) Locality; (d) Postcode; (e) Country; (f) Phone or E-mail; (g) Role.
2. Device: (a) Internationally recognised nomenclature code (for data generated after 1 May 2011); (b) Device Name/Make or, where not available, generic name.
3. Certificate (of the Notified body): (a) Certificate number; (b) Certificate type; (c) Date of Issue; (d) Expiration Date; (e) Manufacturer and, if applicable, authorised representative (see fields under 1. Actor); (f) Notified Body (selected from system); (g) General Scope description and, where applicable, details on device (see fields under 2. Device); (h) Status and, where applicable, reasons for decision of Notified Body.

Regards

Xavier Canals
 
Last edited:

rob73

looking for answers
#9
As I understand it the purpose Eudamed is for competent authorities to pass vigilance and surveillance information easily. So no public access.
There is a page explaining this but I cannot add the link. Maybe one of the regulars could.
Rob
 

xcanals_tecno-med.es

Involved In Discussions
#10
As I understand it the purpose Eudamed is for competent authorities to pass vigilance and surveillance information easily. So no public access.
There is a page explaining this but I cannot add the link. Maybe one of the regulars could.
Rob
Yes Rob,
as stated in the Commision website:

http://ec.europa.eu/enterprise/sectors/medical-devices/market-surveillance-vigilance/eudamed/

Who can access Eudamed?
Eudamed is a secure web-based portal acting as a central repository for information exchange between national competent authorities and the Commission and is not publicly accessible. Eudamed is currently being used by a number of Member States on a voluntary basis and will be obligatory as from May 2011

but note that most of the data included was changed in the amendment directive 2007/47/EC as non confidential in order to be published in a near future.

Regards

Xavier Canals :agree:
 
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