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CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
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CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
CE Marking & Compliance to MDD, EMC, RoHS, and GPSD
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CE Marking & Compliance to MDD, EMC, RoHS, and GPSD


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Some Related Topic Tags
ce mark and ce marking, class i medical device, gpsd (general product safety directive), mdd (medical device directive), rohs (restriction of hazardous substances), technical files for medical devices
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  Post Number #1  
Old 31st January 2018, 06:02 PM
tebusse

 
 
Total Posts: 79
Please Help! CE Marking & Compliance to MDD, EMC, RoHS, and GPSD

Hello everyone!

I may show my inexperience with question, but the time has come to ask.

I'm a single-person QA/RA unit and am putting together my first technical file documentation for a Class I, non-measuring/non-sterile device. However, the device is electronic and I understand that we have to comply with not only the MDD, but also the EMC, RoHS, and GPS directives.

Our device has been tested by a 3rd party to ensure compliance with IEC 60601, CISPR, and IEC 61000. Our suppliers are RoHS compliant. However, do I need to generate separate DoC for each directive or can all directives be listed on one DoC? Also, is it enough to document the directives in the applicable sections of my ER checklist and provide objective evidence?

Any assistance in navigating my regulatory conundrum would be most helpful.

Tonia

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  Post Number #2  
Old 1st February 2018, 12:07 PM
3dBUnderThe Limit

 
 
Total Posts: 15
re: CE Marking & Compliance to MDD, EMC, RoHS, and GPSD

From my point of view you would need MDD and RoHS from your list(WEEE? Battery directive? .....).
EMC is managed 60601-1-2 and GPS direktive is can't be applicable to a Medical Device.

I would assume that you can write one DoC for all EU directives that are applicable, I have seen both types in the wild.
Thanks to 3dBUnderThe Limit for your informative Post and/or Attachment!
  Post Number #3  
Old 1st February 2018, 12:15 PM
tebusse

 
 
Total Posts: 79
Re: CE Marking & Compliance to MDD, EMC, RoHS, and GPSD

Thank you.

The device does contain a rechargeable lithium ion battery, so the WEEE directive definitely applies.

The device should meet the EMC directive since it's been tested by a 3rd party (presumption of conformity).
  Post Number #4  
Old 2nd February 2018, 05:22 AM
3dBUnderThe Limit

 
 
Total Posts: 15
Re: CE Marking & Compliance to MDD, EMC, RoHS, and GPSD

My point for EMC is that you do not need to (should not?) claim compliance to the EMC directive, this should be a part of your 60601-1 (60601-1-2) compliance to MDD/MDR. I'm not sure if comlying to the EMC directive will be equivalent to the requirements in 60601-1-2.

For the battery I think that the battery directive is applicable as well

Last edited by 3dBUnderThe Limit; 2nd February 2018 at 06:08 AM.
  Post Number #5  
Old 2nd February 2018, 06:44 PM
QuinnM

 
 
Total Posts: 17
Re: CE Marking & Compliance to MDD, EMC, RoHS, and GPSD

Hi Tonia,

Having one DoC is the way to go, less paperwork, easier to track, etc. Each directive identifies the requirements for a DoC. For examples see MDD 93/42/EEC annex II, and EMC 2014/30/EU annex IV. Other guidance is provided in the directives pertaining to DoCs too. When a device falls under any directive, there are requirements for DoCs, then each directive needs to be included. This is for the EU, other countries have other requirements.

Best regards,
Quinn
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