CE Marking MDD & EN 980 Labeling Requirements, IFU, Packaging, etc.

[nick lekanides]

i am currently updating my company to the MDD and ISO 13485, and am currently stuck on a few things regarding the labeling and packaging of my products, especially regarding the Instructions for Use:

1. exactly what products do the Instructions for Use (IFUs) have to be included with? eg. do they only have to be packaged with a complete device? or, do they have to be included with all main components? or, do the IFUs have to be packaged with every individual component and replacement part?

2. what information regarding my company must be included on the IFU? on the labels? eg. the company logo, the manufacturers contacts and address, parts descriptions, expiration dates (if applicable), etc.

[chris1price]

Regarding IFUs and information, take a good read through Section 13 of Annex 1 of the MDD. Firstly, they are not required for class 1 and 2a devices that can be safely used without them. Otherwise, whenever they are required, they should be available to the user of the device. (Unfortunately, electronic copies or instructions on the internet are still not acceptable.)

A replacement part would not be CE Marked in its own right, and the user should already have a copy of the IFU. However, instructions on how to fit the part may be requried.

Section 13.3 to 13.6 lists out everything that needs to be on the labels and IFU. Don't forget the name and address of the autherised representative.

[gereard_kgb]

Chris1price is generally right.
Point 13 of annex I of MDD is very good starting point.
When you go in details thrugh all the points you should get all you need.

Yet all depends on the product - as far as the IFUs and labels are concerned. In my opinion this is quite important issue during the audits.

Have you got a notified body chosen? If not, I could recommend one with a very nice auditor who could give some additonal guidliness and present their requirements.

Moreover, I would recommend (on the condition this is available) to take labels and IFUs of you competitors and check what they have... this kind of benchmark testing could be very valuable (and has always been accepted by our notified body - which I could recommend).

Good luck!

[wrodnigg]

nick lekanides,

you could also take a look into the standard EN 1041 "Information supplied by the manufacturer with medical devices". There is a prEN 1041:2006 draft of the standard.

Both contain a nice table in the annex, where all of the Annex I requirements are explained in detail (not only Section 13 contains requirements for IFU and labeling).

chris1price, take into account, that many devices are intended to be used by lay people.

From MDD, Annex I 13.1:

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

For lay people there shall be IFU provided by the manufacturer, for professional use there will be some discussions, why no IFU are required.

Since the new competent authority inspection teams are visiting class I manufacturers, there have been many many non conformities according to non existent IFUs.

~ghw

[Madly RA'd Woman]

Originally Posted by chris1price

Regarding IFUs and information, take a good read through Section 13 of Annex 1 of the MDD. Firstly, they are not required for class 1 and 2a devices that can be safely used without them. Otherwise, whenever they are required, they should be available to the user of the device. (Unfortunately, electronic copies or instructions on the internet are still not acceptable.)

A replacement part would not be CE Marked in its own right, and the user should already have a copy of the IFU. However, instructions on how to fit the part may be requried.

Section 13.3 to 13.6 lists out everything that needs to be on the labels and IFU. Don't forget the name and address of the autherised representative.

I am not finding the name and address of the authorized rep as a requirement in Annex II Section 13. Has it been amended, or is it just standard practice?

Thanks!

[Al Rosen]

Originally Posted by Madly RA'd Woman

I am not finding the name and address of the authorized rep as a requirement in Annex II Section 13. Has it been amended, or is it just standard practice?

Thanks!

That's because it's in Annex I not Annex II.

[wrodnigg]

Yes, it is written in Annex I clause 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 either the
person responsible referred to in Article 14 (2) or of the authorized
representative of the manufacturer established within the Community
or of the importer established within the Community, as
appropriate;

Also the symbols from EN 980 for "manufacturer" and "ec rep" should be used