Date : 11-04-11 14:57
Requirement of MDD Label
 Name : CE Manager
Hit : 389  
13.3. The label must bear the following particulars:

(a) the name or trade 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;
,B (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
(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
(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; ,M2
(n) in the case of a device within the meaning of
Article 1(4a), an indication that the device contains
a human blood derivative.