CE Marking for Power Supply for Medical Device - Class IIb device per MDD, Rule 11

[vpanchal]

Hello ,

I am new to the Forum,, I find it very useful. Thanks for very useful information.

I have a Question regarding Power Supply. We manufacture infusion
pumps Classifed as Class IIb device per MDD, Rule 12. We use a Switch Mode
Power Supply ( AC Input and DC Output) from a Supplier who evaluates to
IEC 60601-1 Safety Standard and Marks it with CE Mark.
Since this Power Supply is used with a Medical Device, Does this Power Supply become an accessory with the Medical Device.?
Since Power SUpply is not non invasive device, Is it Classified as Class I device or Class IIb based on its usage with pump?

What type of Declaration of Conformity does the Power Supply
Manufacturer has to provide to us? Is it DOC to MDD or Low Voltage Device?

If its MDD, then Does the Power Supply Manufacturer has to prepare a
Technical File as well as the End Product User (Pump)?

Thanks

VP

[Al Rosen]

Your device cannot be in class IIb according to Rule 12, since Rule 12 establishes Class I.

Originally Posted by MDD

3.3. Rule 12
All other active devices are in Class I.

Please clarify.

[vpanchal]

I apologize.. Rule 11.. All active devices intended to admnister and/or remove medicines. body liquids or other substances to or from body are in Class IIa, unless this is done in a manner:
-that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which they are in Class IIb.

once again, I apologize for stating Rule 12..

Thanks.

[Al Rosen]

If the PS mfr Has declared that the PS complies with IEC-60601-1 and is in compliance with the LVD it is sufficient since your device will comply with the MDD and this PS will be a component of it, not an accessory, and classification is not an issue. You will have a description of the PS and a DoC in your device's TF. I don't think you will or could have a TF for the PS since you do not have the details required.

I'm not sure I understand:

Since Power SUpply is not non invasive device, Is it Classified as Class I device or Class IIb based on its usage with pump?

But in any case, read the attached MEDDEVs, 2.1/1, Definitions of "medical devices", "accessory" and "manufacturer" and 2.4/1, Classification of MD.

Discuss it with your NB for verification since I am basing this on my experience and application.