Where to find the Medical Device Classification Database

D

DRDDO

#1
Dear Team,
I am DRDDO.
I have a problem, and some body too! when read MEDDEV2.4/1 Rev.8 July 2001. It is not easy to classify the MDD, class 1, 2a, 2b or 3.
:read::bonk::frust:
Right now nore than 25ooo MDD that already been certified CE mark.
I beleive there are database, But No idea where!
If someone know where I can reach the database the contained already classified MDD, I will appreciate.
:magic:
DR D DO
 
Elsmar Forum Sponsor

Weiner Dog

Med Device Consultant
#6
Dear Team,
I am DRDDO.
I have a problem, and some body too! when read MEDDEV2.4/1 Rev.8 July 2001. It is not easy to classify the MDD, class 1, 2a, 2b or 3.
:read::bonk::frust:
Right now nore than 25ooo MDD that already been certified CE mark.
I beleive there are database, But No idea where!
If someone know where I can reach the database the contained already classified MDD, I will appreciate.
:magic:
DR D DO
FDA device classifications are different then those for CE marked devices.

For FDA regulated devices, devices are classed as class I, class II, and class III. Some class I devices are exempt from certain general control activities. Some class II and class III devices are also life-sustaining and/or life-supporting devices.

CLASS REGULATORY CONTROLS
Class I General Controls
Class II General Controls and Special Controls
Class III General Controls and Premarket Approval

For additional information, refer to http://www.fda.gov/cdrh/devadvice/
 
D

DRDDO

#8
Thanks QA-Man,
Many time that classification is not corrected, I must ask My Notify body!
Same as US FDA Claification database, I beleive there is CE Classification Database?
I mean database that MDD already classified!
But where in cuberspace?
Thanks,
DRDDO
 
O

ODISSEAS

#9
Hi friend,

to date, as far as i know, there is no any "a priori" classification under MDD for the huge amount of existing medical devices. Talking in operating terms, this list is not a difficult step to take, provided that UMDNS classification has been made and includes devices into 12 possible classes. Why not then?. Because if there was a priori classification it would be assumed as a legal and authomatic recognition of class to wich manufacturers should include their devices. The directive, if i am not wrong, explicites that manufacturer is the one who should carry out classification, always taking into account intended purpose.
 
A

Adele

#10
DRDDO,

It is the responsibility of the manufacturer to classify their own device according to the classification rules in Annex IX of the MDD. The classification is based upon the manufacturer's intended use of the device.

During an audit, the Notified Body will typically assess the Class asssigned by the manufacturer. You should be prepared to justify why you consider a particular product to be a certain Class.

To help determine the class and be able to show your reasonings for choosing that class, you should document whether your device is transient, short term, or long term; whether your device is invasive, non-invasive, or active (according to Annex IX definitions); and what Rule your device is classified under i.e., Class IIa (Rule 9).

There is no obligation for either the manufacturer or Notified Body to publish this information on a searchable database.

Hope this helps!
 
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