Quote:
In Reply to Parent Post by RAspecialist
Hello
I wonder if anyone can help? I have an instrumentation set which requires labelling but has very limited space. Therefore can anyone advise what information MUST, as a bare minimum, appear on the outer case for the EU?
Will the product name, product code and CE mark be ok? Or do I need to include others e.g. Manufacturer?
In an ideal world I would have everything, but space available for labelling is very limited.
I will, of course, be including everything on the IFU contained within.
Many thanks
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Hello
note that the minimun requirements in the label are established in the essential requirements of the annex I of the directives, for the case of the dir 93/42/EEC the requirements are:
13.3. The label must bear the following particulars:
(a) the name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;
(b) the details strictly necessary to identify the device and the contents of the packaging especially for the users;
(c) where appropriate, the word ‘STERILE’;
(d) where appropriate, the batch code, preceded by the word ‘LOT’, or the serial number;
(e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month;
(f) where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;
(g) if the device is costum-made, the words ‘custom-made device’;
(h) if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’;
(i) any special storage and/or handling conditions;
(j) any special operating instructions;
(k) any warnings and/or precautions to take;
(l) year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number;
(m) where applicable, method of sterilization;
(n) in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.
For an instrument in general you will need:
(a) the name and address of the manufacturer.
name and address of the authorised representative (if manufacturer is not european)
(b) REF symbol with catalog number and product name
(d) SN symbol with the serial number (includes the year of manufacture)
(k) symbol "SEE IFU" (the book from EN 980);
but also :
-symbol CE (with NB number if applicable)
-symbols as per EN 60601-1 (if applicable as an electromedical instrument)
remember also for Europe to include the symbol WEEE (crossed-out wheeled bin) on the product and IFU
Regards
Xavier Canals
Labelling Requirements - Bare minimum Class I Medical Device Instrumentation
Linear Mode
