M
Hi There!
Wondering if anyone can offer some advice as to labelling a small medical device.
The device is a wireless earpiece, much like a bluetooth ear-clip.
So, my question is: what exemptions can be made for small devices?
Most of the information required by the MDD will be in the instructions for use booklet.
The MDD (annex I, section 13) uses "where appropriate..." several times. Can this be interpreted as "where space permits..."?
We'd like, at minimum, a serial-number on the device somewhere (so we can identify it). ...but is it necessary that such a number be immediately visible by the user? For example, is is permissible to place the label on the inside of the device (so it can be accessed only by opening the casing).
Any advice, links etc. greatly appreciated.
Thanks in advance,
MM.
Wondering if anyone can offer some advice as to labelling a small medical device.
The device is a wireless earpiece, much like a bluetooth ear-clip.
So, my question is: what exemptions can be made for small devices?
Most of the information required by the MDD will be in the instructions for use booklet.
The MDD (annex I, section 13) uses "where appropriate..." several times. Can this be interpreted as "where space permits..."?
We'd like, at minimum, a serial-number on the device somewhere (so we can identify it). ...but is it necessary that such a number be immediately visible by the user? For example, is is permissible to place the label on the inside of the device (so it can be accessed only by opening the casing).
Any advice, links etc. greatly appreciated.
Thanks in advance,
MM.