Essentials of European Medical Device Regulatory Affairs - June 2020
Symbols for Use in the Labelling of Medical Devices Need no further explanations (examples)
Symbols which need explanation:
- Contains natural rubber latex
- Do not resterilize
- BS EN ISO15223. FDA recognises 25 symbols (for IVD use)
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23. 2 label
b)
Indicate the intended purposes of device if not obvious to user
c)
Name and address of manufacturer
d)
If a manufacturer outside the union include the name and address of the
in the Community authorized representative
h)
UDI
TheOrganisation for Professionals in Regulatory Affairs
Instructions for the User (IFU)
• Most of label information is repeated on IFU
• An additional 27 things to consider including
• Plus remember section 10.4 lists substances which may need to be acknowledged
TheOrganisation for Professionals in Regulatory Affairs
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