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Does a Medical Device Battery need CE Mark

P

pkost

Trusted Information Resource
#11
#11
As you are outside the EU you have to appoint an authorised representative within the EU as a legal point of contact for the EU authorities. Where your authorised rep is located defines your competent authority.

I'm not sure whether the CA's will speak to you without an authorised rep, but you can give it a go if you want....the MHRA in the UK is an obvious choice as they will speak English, alternatively the irish CA for the same reason
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#12
#12
Bruce Banner said:
Regarding CE marking, which is the competent authority to contact about that?
Click to expand...
Actually, I would try with a notified body before escalating to one of the competent authorities. Most of them will be able to communicate well in English (regardless of their location). If your device is not a non-sterile class I with no measuring function device, you'll have to formally engage with a notified body anyway.

Another thing - did you check whether other EC directives apply (i.e. other than the MDD)?

Cheers,
Ronen.
 
Last edited:
P

pkost

Trusted Information Resource
#13
#13
I would have suggested the NB but I believe the battery would count as a class 1 so be outside of their remit. I've always found our CA to be most helpful but then so has our NB.
 
R

recruit

#14
#14
pkost said:
Hmm, that's more difficult to answer. I personally would call it a component if the battery was sealed in the device and required servicing to replace. I think if the battery is sold seperately from the main device and easily replaceable then it has to be considered an accessory. This is because you are placing the battery on the market where this is defined as:



edit: to be honest it shouldn't be difficult to CE mark them as they should be encompassed by the technical file of the main device so all you need to do is identify their classification and state that they are avaliable seperately
Click to expand...
I have further questions. I wonder if the custom-ed battery should be classified with main device. If not, the battery should be classified into I regardless of the main device. So CE marking without NB number is applicable. Is it necessary for separate CE Technical File in order to issue DoC of the battery? Or we only need to mention it within CE TF of main device?
 
P

pkost

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#15
#15
The technical file is not restricted to products of a single classification. If the NB is asked to review the technical file because the a IIa,b or III device that is contained within they will only examine the necessary areas to do that and will ignore areas that solely relate to the class I device.
 
R

revolution_2006

#16
#16
I'm not sure if this information is timely enough to be of use or not, but I recently went through CE marking of a Class III active implantable life sustaining device with 2 removable, custom batteries, 1 internal custom battery and one off the shelf 9-volt battery. The system was CE marked together, which makes sense when you consider that all of the emissions, functional, thermal, safety, etc. tests are performed on the system. The removable external batteries are CE marked with the system as accessories, are listed by part number (REF) on the ISO certificate and are labeled with the CE mark to facilitate shipment of replacement or spare batteries into the EU. There have never been any additional questions regarding import to numerous countries in the EU related to medical device/CE mark approval, although specific regulatory transportation requirements regarding Li-ion batteries present some challenges early-on.
 
M

Mawos78

#17
#17
I have a similar issue regarding spare battery packs! The main system has been discontinoued and its documentation has not been updated for the 2007/47 revision of the MDD. The Battery Pack (customized pack) is still on the market with a printed CE Mark on it, since this battery is still needed as a spare part for the products available in the hospitals.
There is no Technical File existing for this battery (class I) and no DoC linked to it! This is in my eyes not acceptable, but based on a management descision this battery will be sold in future!
Is there a different approach existing for spare parts?
Thanks for your help!
Martin
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#18
#18
Mawos78 said:
I have a similar issue regarding spare battery packs! The main system has been discontinoued and its documentation has not been updated for the 2007/47 revision of the MDD. The Battery Pack (customized pack) is still on the market with a printed CE Mark on it, since this battery is still needed as a spare part for the products available in the hospitals.
There is no Technical File existing for this battery (class I) and no DoC linked to it! This is in my eyes not acceptable, but based on a management descision this battery will be sold in future!
Is there a different approach existing for spare parts?
Thanks for your help!
Martin
Click to expand...
Hi,

In my opinion this customised battery pack would count as an accessory to the main system (medical device) and as such it is (at least now, with the main system no longer being placed on the market) regulated similar to a stand-alone medical device. I agree that it isn't acceptable that this pack bears the CE mark while not complying - no tech file and no DoC.

BTW, does the battery bear a NB number (being, supposedly, previously cleared with a class >I device)? If so, what do they say?...

Cheers,
Ronen.
 
W

w_grunfeld

#19
#19
Bruce Banner said:
Regarding CE marking, which is the competent authority to contact about that?
Click to expand...
Very good question. I don't think there is any, based on the following response to a query on a similar issue I just got :
"You have written that your client intended to place a Plaster-less Adaptor for Dental Articulator on the market and that you were of the opinion that this product did not fall under the definition of a medical device. I understand that you would like to know if a formal interpretation can be received from an official European entity .

I strongly believe that there is no process at the European Commission to issue such interpretations. In my opinion the European Commission services do not provide an interpretation on a product.


Ingrid GILLISJANS
Assistant Policy Officer/Web Correspondent European Commission DG Enterprise and Industry Standardisation Unit (ENTR.C5)
B100 01/08
B-1049 Brussels/Belgium"
 
P

pkost

Trusted Information Resource
#20
#20
The ec will not issue a formal response as this is not their purpose. You must contact your local competent authority or, if you are based outside the eu, contact the ca local to your ec-rep
 
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