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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