Olivia, my first bit of advice is to proceed with caution. If it sounds too good to be true it probably isn't!
In applying the Low Voltage Directive 2014/35/EU to your electrical/ electronic equipment you first need to be sure the product lies fully within scope, as the LVD scope has numerous exclusions and specific conditions and restrictions. Next you need to be sure your product meets all related EU regulations/ directives, as applicable, such as for example the Electromagnetic Compatibility Directive 2014/30/EU, EU RoHS Directive 2015/863, REACH Regulation 1278/2008, WEEE Directive 2012/19/EU, etc. etc including all updates as on date. Depending on how the product will be marketed and used, you may need to obtain safety markings from Test Labs, such as the UL 'Listed' or TUV 'General Safety' or similar markings, which would typically involve considerable testing and product certification before the CE Marking can be affixed. Involvement of the appropriate Test Lab, whether DEKRA or TUV or UL, early in the piece would greatly help determine the extent and scope of testing necessary, and can greatly help with identification of the correct Harmonized Standards (which are not quite so clear-cut as for medical devices). If the same product is being marketed globally, you may want to consider also such aspects as FCC, C-Tick mark, UL C/US Listing, etc. etc. in the first instance.
It has been my experience that a product designed, specified and built to one Directive (e.g. MDD) does not readily lend itself to comply with another.
In conclusion, your first priority may well be to correct management's rose-tinted view that this route is a walk in the park! Good luck and best wishes!
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Homi Dalal RAC
Regulatory Affairs Leader
Christchurch
New Zealand
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Original Message:
Sent: 04-Feb-2019 12:42
From: Julie Omohundro
Subject: Non-medical "devices" and registration
Ah, good. That is helpful. Although, unfortunately, I don't know anything about the LVD, so I can't be. Helpful, that is. Hopefully someone else here can.
If not, I recommend Elsmar Cove:
https://elsmar.com/
Click on the lighthouse photo to enter the Forums. Then to the Search field in the upper right hand corner of the page and type in "low-voltage directive". You will be amply rewarded. :)
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 04-Feb-2019 12:02
From: Olivia Mullen
Subject: Non-medical "devices" and registration
I edited my initial inquiry - I'm basing it on the Low Voltage Directive (LVD) not the MDD or MDR.
Thank you!
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Olivia Mullen
Compliance / Regulatory Affairs
Birmingham AL
United States
Original Message:
Sent: 04-Feb-2019 10:05
From: Julie Omohundro
Subject: Non-medical "devices" and registration
If you are saying you want to CE Mark a product that is not a medical device under the EU MDD, you can't do it. It's the Medical Device Directive, applicable only to medical devices (e.g., used for a medical purpose). I'm guessing the MDR is the same, because this is how the CE Mark works generally. You would need to find a different Directive applicable to your product, or you are stuck meeting the different requirements of each of the individual countries.
You MAY be able to sell your CE Marked medical device for non-medical use IN ADDITION TO its medical use, but you probably won't be able to change much on the packaging or labeling (because that would make it a different product, one that is not a medical device and therefore not the product covered by your CE Mark). If you have an NB for your medical devices, consult with them. If not, feel free to message me. I did this once, with a product line of medical devices that lent itself well to this little work-around. I'm not sure if my experience will apply to your device, but I would be happy to share my experience with you.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 04-Feb-2019 08:29
From: Olivia Mullen
Subject: Non-medical "devices" and registration
Hello all!
This might be a bit out of the scope of this forum, but I'd appreciate any insight if it can be given.
Over the past year, our company has had a lot of interest in using our medical device for non-medical applications. In my regulatory role, I've been asked to get a technical file together to get a non-medical CE mark. Has anyone had any experience with this? From the directive, it looks as if I self declare. So I only have to get the technical documentation together, create a DoC and get an authorized rep? Then I can put the CE mark on it with no submission or authority approval? This is so very different from the medical side, I'm afraid I'm missing something.
Thank you in advance!
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Olivia Mullen
Compliance / Regulatory Affairs
Birmingham AL
United States
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