MDD Essential Requirement 13.6(q) regarding IFU revision

[NECNEC]

Hi I have a question
The date of last revision is mandatory for IFU as required by MDD
we must also indicate the revision date on product labels and boxes?
thanks

 

[Sam Lazzara]

For both the MDD and AIMDD, the requirement for indicating "date of issue or the latest revision" does not apply to labels. This requirement is clearly restricted to the IFU (see MDD ER 13.6, last bullet and AIMDD ER 15, last bullet). ER = Essential Requirement in Annex I.

Attached to this message you will find the current versions of the MDD and AIMDD combined into a single PDF.

Sam

 

[kirkus67]

The MDD requirement shown below could be interpreted in a couple ways.

13.6. Where appropriate, the instructions for use must contain the following
particulars:
(q) date of issue or the latest revision of the instructions for use.

Must the IFU always contain a date, or is it acceptable if the IFU indicates the latest revision by another method, such as a letter revision? My interpretation is that a date is always required.

I have a colleague that is interpreting this to mean that another method of revision indication, such as a letter revision, would be sufficient.

Any informed opinions on this?
Does the latest MDD have a "preamble" or the like that provides context for this and other requirements?

Per USA 21 CFR 801.109(e): All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
This is more clearly written and I suspect this is what is meant by the MDD requirement 13.6(q).

Thank you
Sam Lazzara

I'm glad you're bringing this to the discussion. What appears to be a clearly stated "OR" statement still leads to ambiguities. This issue came up at a recent audit, and I thought I just had to roll over and add the 'date of issue' to our IFU. Upon review of the requirement, it's clearly left as a choice for the manufacturer. That's what is stated in the current standard.

Now this makes sense to me. (I need my world to make sense... even if I have to fool myself.) We need to have control of the IFU, so we know when and how it was revised.

Thank you.

Kirk

 

[NECNEC]

thank you for your suggestion
I Have an other question
after the 31th march 2010 when there is a revision of IFU we must indicate the date of revision (ok, it'e clear)
if after the 31th march 2010 I have not revised my IFU , now I must intruduce the date in the IFU?
or I can commercialize the product without the revision date on the IFU, until a now revision?
thank you

 

[philou49]

hello
From my point of view all products place on market after march 21 must have the date of revision. In my company we have print as many sticker with date of revision as we have IFU in stock and applied this sticker on each IFU (more than a thousand... it was funny !!!)

regards

 

[pkost]

thank you for your suggestion
I Have an other question
after the 31th march 2010 when there is a revision of IFU we must indicate the date of revision (ok, it'e clear)
if after the 31th march 2010 I have not revised my IFU , now I must intruduce the date in the IFU?
or I can commercialize the product without the revision date on the IFU, until a now revision?
thank you

If you place a device on the market after March 2010 you must comply with all of the requirements of the revised directive; therefore you must have either a date of issue or revision identifier on the IFU.

There is no allowance for you to include it when you next update your IFU.

 

[kirkus]

This question has popped up once again.

In both the MDD Annex I, 13.6q and 21 CFR 801.109(e) is the use of the conjunction "OR".

• MDD, Annex I, 13.6 (q) state to use: ...date of issue or the latest revision
  
• 21 CFR 801.109 (e) states to use: ...the date of the issuance or the date of the latest revision.

Taken literally, this means I can choose either (date of issue or revision) to control my IFU, in both the EU and US.

Years ago, an ISO auditor also read this requirement as both the date of issue AND the latest revision were required. Confounding!

 

[somashekar]

This question has popped up once again.

In both the MDD Annex I, 13.6q and 21 CFR 801.109(e) is the use of the conjunction "OR".

• MDD, Annex I, 13.6 (q) state to use: ...date of issue or the latest revision
  
• 21 CFR 801.109 (e) states to use: ...the date of the issuance or the date of the latest revision.

Taken literally, this means I can choose either (date of issue or revision) to control my IFU, in both the EU and US.

Years ago, an ISO auditor also read this requirement as both the date of issue AND the latest revision were required. Confounding!

If you have to make one system for both EU and USA., then a date becomes essential on the IFU.
Your system has to show your controls that, that date is of the current version on your masters.
.... And a warm welcome to the COVE kirkus ~~~

 

[MIREGMGR]

The company for which I work puts the rev level on each of our hundreds of IFUs. This is an element of our part numbering system, and IFUs are controlled as parts.

We manage IFUs and labels identically.

There is no revision/version date on any of our IFUs. The only dates on our labels are the manufacturing date, and in the case of products with a defined lifetime related to functionality and/or sterile barrier packaging, an expiration date. We globally market and have been following this approach for at least two decades, and our various regulatory overseers and auditors have not objected.

 

[Mark Meer]

If we were nitpicking the literal interpretation here I'd say a simple comma (or lack of) makes all the difference:

"date of issue or the latest revision" = date is required which could be either the issue date or the latest revision date (which doesn't make much sense, as these would presumably be the same date).

Versus

"date of issue, or the latest revision" = either the date of issue OR a revision level


As indicated, the FDA is less ambiguous and clearly dictates a date in either case ("the date of the issuance or the date of the latest revision").
My suggestion would be to just include a date, regardless. This would cover any interpretations of both FDA and MDD requirements.