Essentials of European Medical Device Regulatory Affairs

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) 95

ER 13. 3 label a) Name and address of manufacturer For imported products the name and address of the in the Community authorized representative b) Identification of device and contents of packaging c) STERILE, if appropriate

d) Where appropriate, batch codes (LOT) or serial number e) Where appropriate, expiry date(year, month) yyyy-mm f) Where appropriate, an indication that the device is for single use g) Where appropriate, ‘custom made device’ h) Where appropriate, ‘exclusively for clinical investigations’

i) Storage and/or handling conditions j) Any special operating instructions k) Any precautions or warnings

l) Year of manufacture for active devices if not covered by (e) m) Where applicable the method of sterilization e.g. As a symbol n) If appropriate indicate device contains a human blood derivative

Indicate the intended purposes of device if not obvious to user

MDR: GSPR 23: 23.1 (a)-(h); 23.2 (a)-(s); 23.3 (a)-(j); 23.4 (a)-(ab)

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