Clarification on USe by date and EC Rep address on IVD INSTRUMENTS!!


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1. I found from 98/79/EC IVD directive,"Use by date" has to be placed for IVD instruments. But for instruments, how can we find/develop expiry dates??
Is it compulsory to put expiry date on labels??

Or any requirement to put MANUFACTURING date for INSTRUMENTS?

2. EC Rep address: Is it required to put EC Rep ADDRESS BOTH on primary label and IFU/User Manual?? Or is it ok, if we place the address, on ANY ONE of them??

Pls reply.



Quite Involved in Discussions
Hi all,
Some info for the manufacturing and expiration date for IVDs is as follows:

Manufacturing date: The IVD device doesnot require the manufacturing date. However, EN 1658 requires not only the serial or lot number but also, if appropriate, the date of manufacture in yyyy-mm-dd format (EN 1658 section 4.2). Unfortunately, there is no guidance is provided about the conditions that would make the date of manufacture as “appropriate” as a marking on the instrument.

Expiration Date: One does not usually think of an instrument as having an expiration date. However, some IVD instruments, particularly ones intended for self-testing, may have a date before which they should be used. An example could be an instrument with a battery that cannot be changed by the user. If this is the case, the outer container label and possibly the label of the instrument itself should bear an expiration date. If present, the expiration date may be expressed as the year, month and day (yyyy-mm-dd), or as yyyy-mm. If the later form is used, the expiration date is the last day of the month indicated. The use by symbol may be used to identify the expiration date.

Resource: "International Labeling Requirements for MEdical devices, Medical Equipment and diagnostic products", Charles B. Sidebottom.