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This document lists the labeling requirements for medical devices according to the 93/42EEC amended by 2007/47 Medical devices directive. It includes 13 requirements for labels including providing the name and address of the manufacturer, identifying details for the device and contents, sterility or batch/serial numbers where needed, expiration dates, intended use, special storage/handling, operating instructions, warnings, year of manufacture, and sterilization methods.

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55 views

Simple Review PDF

This document lists the labeling requirements for medical devices according to the 93/42EEC amended by 2007/47 Medical devices directive. It includes 13 requirements for labels including providing the name and address of the manufacturer, identifying details for the device and contents, sterility or batch/serial numbers where needed, expiration dates, intended use, special storage/handling, operating instructions, warnings, year of manufacture, and sterilization methods.

Uploaded by

India Rose
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Joe Bloggs Labelling Content Review

Limited
Product:
93/42EEC amended by 2007/47 Medical Label ref #
devices directive.
Item 13.3
Requirement A or N/A Information required
(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

(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 custom-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;

(j) year of manufacture for active devices other than those covered by
(c). 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 l(4a), an


indication that the device contains a human blood derivative.

Simple Review 1 of 1 Printed: 01/03/2013

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