MDD Essential Requirement 13.6(q) regarding IFU revision

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

Sam Lazzara said:

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

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 would rewrite the requirement as follows to improve clarity:
(q) revision date of the instructions for use.

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 had a "preamble" or the like that provides context for this and other requirements?

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.

Thank you
Sam

Click to expand...

Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.

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 authorized 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;

(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;


(h) If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;

(o) medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;

(q) date of issue or the latest revision of the instructions for use.

I don't know of an authoritative reference as to "drafters' intent". I'm not aware of an interpretation or guidance by a Notified Body, Competent Authority, etc.

My company's interpretation is that the functional requirement is for provision of an effective means for the end user to be able to quickly compare the IFU version-level they have against a version-level reference. Either date or rev level will accomplish that, if a corresponding version-level reference also is available.

Sam Lazzara said:

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

Click to expand...

Hi Sam Lazzara

In my view the wording of Section 13.6 (q) of the amended Directive 93/42/EEC which you quoted is self-explaining. I.e. the IFU must contain the date of their issue or of their latest revision. But I do not understand your question regarding a "letter revision".

Directive 2007/47/EC contains a number of recitals which precede the operative part of the directive.

By "letter revision" I am speaking about the common practice of giving documents a letter revision like A, B, C, etc. These letter revisions are not accompanied by a date, but they do unambiguously describe the revision level of the document.

Sam Lazzara said:

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?

Click to expand...

The latest revision is sufficient and the IFU doesn't have to be dated.

You can use whatever method you wish to control this document.

On our IFU we had previously a reference number and an revision leter (100111:A) for exemple. there were no ambiguity about IFU revision number, But our notify body requested us to add the revision date in a clear wording.

FYI

"in a clear wording"? In what language? We cant repeat it for every language. If I put something like "Rev. 2010-12a" is that acceptable, or is there a symbol or other method to indicate what the date represents without using a language-specific term or abbreviation??

Base on my last audit by a notified body, only a date without any texte is enough if its position in the IFU is not ambiguious, for example in bottom page or on back cover near IFU reference. Sorry if I used "clear wording", it was just to say that an internal reference that can't be easily understand by a user is not allowed. In my case "ref 100111A" as been modified by "ref 100111B 20/3/2010"

Thanks philou49,

Also you may want to consider (even though your NB apparently did not) that EN 1041 says:

"4.4 Dates
Any human-readable date shall be expressed in the format YYYY-MM-DD, YYYY-MM or YYYY, in accordance with ISO 8601.
NOTE The choice of format will be determined by the requirements of the relevant Directives and the specific nature of the devices concerned."

I believe this is intended to be a human-readable date, so the best option would probably be to use one of the date formats listed, most likely YYYY-MM. I notice it seems common to use MM/YY, but this is also a new requirement so maybe not everyone is completely compliant, but I plan to use YYYY-MM... does anyone think this is incorrect?