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Advice on Device classification under MDD Annex IX.

somashekar

Staff member
Super Moderator
#1
MDD experts... please help me to classify these medical devices.
Orthopedic implantable devices : Is it class 2b or 3 in Rule 8 ?
Wound suction drainage system : Is it class 2a or 2b in Rule 11 ?
Also let me know if I am looking at the correct rules ~~~
:thanx:
 

bio_subbu

Super Moderator
#2
Re: Advise on Device classification under MDD Annex IX.

MDD experts... please help me to classify these medical devices.
Orthopedic implantable devices : Is it class 2b or 3 in Rule 8 ?
Wound suction drainage system : Is it class 2a or 2b in Rule 11 ?
Also let me know if I am looking at the correct rules ~~~
:thanx:
Hi Somashekar

Please refer the existing thread "European Medical Devices Classification “MEDDEV 2. 4/1 Rev. 9 June 2010" and you can find the classification details on the attached excel sheet "Classification of medical devices"

Regards
S.Subramaniam
 
#3
Re: Advise on Device classification under MDD Annex IX.

After a quick check I would agree with your classifications.

Ortho' implant - IIb (unless it has biological action) (rule 8)

Wound drainage - IIa (rule 11)

Regards

Pads
 
#4
Re: Advise on Device classification under MDD Annex IX.

Don't forget that total hip, knee and shoulder replacements are class III as per Directive 2005/50/EC
 

somashekar

Staff member
Super Moderator
#5
Re: Advise on Device classification under MDD Annex IX.

After a quick check I would agree with your classifications.

Ortho' implant - IIb (unless it has biological action) (rule 8)

Wound drainage - IIa (rule 11)

Regards

Pads
I really have no idea of how to understand this "Intended to have a biological effect" part for the orthopedic implants, however its classification under Class III is based out of the Directive 2005/50/EC, per the MEDDEV 2.4/1 Rev9.
Directive 2005/50/EC introduced a derogation from this rule, reclassifying hip, knee and shoulder joint replacements in Class III
Ex. - Total hip, knee and shoulder joint replacements systems and components of systems.
 
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#6
Re: Advise on Device classification under MDD Annex IX.

An example device which has a "biological effect" would be some bone graft replacement materials.

An example implant which is mainly absorbed would be something like a resorbable soft tissue anchor

Both of these would be Class III

I really have no idea of how to understand this "Intended to have a biological effect" part for the orthopedic implants, however its classification under Class III is based out of the Directive 2005/50/EC, per the MEDDEV 2.4/1 Rev9.
This is incorrect, the classification of biological effect or absorbable implants has always been class III. 2005/50/EEC only addresses the reclassification of total hip, knee and shoulder replacements from IIb to III
 
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#7
pkost said:
Don't forget that total hip, knee and shoulder replacements are class III as per Directive 2005/50/EC
Thanks pkost, I wasn't aware of that directive.
It is a little surprising that they did not incorporate the change in the 2007 amendments.
 
#8
I would imagine that it is not included in the 2007 amendments because is a derogation from the rules, it came about through a request made by the UK and French governments under article 13 of the MDD
 

somashekar

Staff member
Super Moderator
#9
I would imagine that it is not included in the 2007 amendments because is a derogation from the rules, it came about through a request made by the UK and French governments under article 13 of the MDD
Thanks guys...
Device Classification comes from MDD Annex IX leading to MEDDEV 2.4/1 Rev9 leading to the various derogations mentioned within the MEDDEV 2.4/1 Rev9.
Thanks to Subbu, pkost for the good insight ...
 
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