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Do I need to comply with both the MDD and the PED for my Medical Device?

M

milagre

#1
Hello everyone,

I am working on a continuous positive airway pressure (CPAP) device. We have been planning from the begining of the project to be compliant with the Medical Device Directive (MDD), but recently a collegue mentioned he thought we needed to also comply with the Pressure Equipment Directive (PED).

I thought this was not the case, as the MDD covers specific pressure-related concerns about the device already. However, my early review into whether or not the PED applies to us has been inconclusive.

Has anyone been in a similar situation before? Does anyone know if the MDD and the PED both apply in this situation (or how I could go about determining that for myself)?
 

Gert Sorensen

Forum Moderator
Moderator
#2
What is the pressure of the equipment? The PED applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.
 
M

milagre

#3
Hey Gert,

Thanks for your input. Our device receives oxygen at pressures up to 6,9 bar. This input is stepped down to around 2 bar by our regulator. I guess that means we must comply to the PED...

Where can I find the requirement for complying to the PED if you are above 0,5 bar?

EDIT: I just read somewhere that the pressure vessel might need to have a certain volume to qualify? Our device only holds a very small amount of gas at an given time, so maybe this exempts us from the PED?
 
Last edited by a moderator:
#4
If your product is a medical device it is covered under the MDD 93/42/EEC only. No other directives apply (other than as of 22nd July RoHS II for CE marking).

Steve
 
#5
I'm not up to scratch with the pressure directive, however article 1(3) states that

The following are excluded from the scope of this Directive
....
[3.6]equipment classified as no higher than category I under Article 9
of this Directive and covered by one of the following Directives
....
Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices (2),
I'm not sure what category your product falls into, but if it's cat I, you don't appear to have to worry about this directive
 
M

milagre

#6
Thanks everyone. My question has been sufficiently answered.

Pkost and SteveK are right that my device is excluded by section 3.6 in the scope. I was having a hard time reading Annex 9 to qualify our device, so I was unsure what to make of 3.6 at first.

:thanks:
 
#7
[3.6]equipment classified as no higher than category I under Article 9
of this Directive and covered by one of the following Directives
Pkost and SteveK are right that my device is excluded by section 3.6 in the scope.
It?s only excluded if it?s category is not higher than category I under article 9 (and article 9 takes you to annex II).

Are you sure your device is category I only?
 
M

milagre

#8
Marcelo,

Per Article 3, we are not even category I by my interpretation. Referring to the requirements listed under 1.1, our device is no where close to containing a product of PS and V of 25 bar L or greater.
 
#9
Per Article 3, we are not even category I by my interpretation. Referring to the requirements listed under 1.1, our device is no where close to containing a product of PS and V of 25 bar L or greater.
Great, so just remember to put the rationale for this somewhere as someone will probably ask this question.
 
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