MDR language requirements

O

Ololo

Registered
#1
#1
Hi Everyone,

We have a MDR devices (Class I and Class IIa that does not have IFU because it can be used without IFU. (Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section. )
The labels have only English and providing an image of the device on the label.

We are planning to sell the product in Spain and Germany. Do we need to translate labels to the languages of member states where the product is going to be sold?
Or picture is enough on label. Is there any regulations that mentioned some exceptions for Labeling. Thank you.
 
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D

DutchMarten

Starting to get Involved
#2
#2
Yes for Spain it has to be in Spanish. For Germany I thought that if the devices are only used by professional users it can be english, however I'm not entirely sure if this is for the whole of the IFU or if important safety information is excluded from this.
 
E

EmiliaBedelia

Involved In Discussions
#4
#4
The product labels need to be translated.

Reference Article 10 point 11 - the device must be accompanied by the information set out in Section 23 of Annex I (the GSPRs) in the languages required by the Member States where it is to be sold. This is where the translation requirement is coming from.

GSPR 23 defines both the product labeling and the IFU. Point 23.1(d) exempts you from providing the instructions for use, but that does not exempt you from providing product labeling. Therefore Article 10 still applies to the device labeling and you need to translate.
 
L

L_O_B

Involved In Discussions
#6
#6
EmiliaBedelia said:
The product labels need to be translated.

Reference Article 10 point 11 - the device must be accompanied by the information set out in Section 23 of Annex I (the GSPRs) in the languages required by the Member States where it is to be sold. This is where the translation requirement is coming from.
Click to expand...
The reference is correct but the consequence is not. Device labels and IFUs are both part of the accompanying information. Article 10(11) just allows the member states to require whatever language they want for this. In the case of Germany, for professional users any easily understandable language is acceptable. Safety related information shall be in German or in the language of the user (probably German). Thus, if your device is intended for professional users only and you do not have any safety related information (in English) on your label, you may place the device on the market in Germany without further translation activities.

Billy Milly said:
Remember that users can always request IFU, even if not supplied with the device and you shall fulfill their request...
Click to expand...
This is not true. If it was not deemed necessary to provide an IFU with the device and this was justified within risk management, no IFU will be issued.
The requirement to provide an IFU in paper form free of charge is related to bulk deliveries (several devices with just one IFU) and devices accompanied by an electronic IFU (Implementing Regulation (EU) 2021/2226). But in both of these cases an IFU already exists.
 
B

Billy Milly

Involved In Discussions
#7
#7
I tend to disagree. Every device shoud have an IFU, you can only justify not providing it for every sold item (within the packaging or similar). But it should still be in the tech file, even if not supplied. See MDR, annex II, 2. I see no exceptions in this requirement.
 
L

L_O_B

Involved In Discussions
#8
#8
Annex II is not a good reference for this cause. A lot of items from annex II may be omitted if they are not deemed necessary for the device,
e.g.
(g) an explanation of any novel features;
(h) a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it;
(k) a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids;
All these items may be omitted from the technical documentation by justifying that they are not applicable for the device. Same applies for the IFU of some class I and IIa devices. In contrast to these three examples the omission of an IFU is specifically allowed based on annex I 23.1(b).
 
B

Billy Milly

Involved In Discussions
#9
#9
I am not trying to change your opinion, so please don't take this the wrong way.
Personally, I would still address the g, h and k above, even if TD just states "no novel features", "no accesories intended", "no contact". This would still leave "description of raw materials in key functional elements". Those are present in any device, even wihtout any contact.
To support my opinions above, I can refer to the shall in Article 10, 4 (manufacturer's obligations).

Regarding Annex I, chapter III, it is named Requirements for information supplied with the device. So you can omit supplying the IFU, but not preparing one. Article 10, 4 requires you to include all ("shall") elements of Annex II or III in your TD. That's my understanding.
 
L

L_O_B

Involved In Discussions
#10
#10
I like being challenged but this case seems rather clear to me and I do not want manufacturers to waste resources.
Billy Milly said:
Personally, I would still address the g, h and k above, even if TD just states "no novel features", "no accesories intended", "no contact".
Click to expand...
That's what I would do, as well. Next I would enter "no IFU required" for section 2, second indent.

Billy Milly said:
To support my opinions above, I can refer to the shall in Article 10, 4 (manufacturer's obligations).
Click to expand...
I do not see the additional point here. "The technical documentation shall include the elements set out in Annexes II and III"
If a manufacturer states that there are no novel features this element is taken care of. Same applies if they state that no IFU is required.

Billy Milly said:
Regarding Annex I, chapter III, it is named Requirements for information supplied with the device. So you can omit supplying the IFU, but not preparing one.
Click to expand...
If you want to interpret it that way you run into another difficulty: If this chapter only applies to information supplied with the device it no longer applies the IFU that is not supplied with the device because, well, it was not supplied with the device. Therefore, there would be no content requirements for the IFU.

Additionally, where would you get the requirement for the manufacturer to provide the IFU upon request take from since you cannot refer to 23.1 (e) or (f) as these are very different scenarios?
 
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