MDR language requirements

[Billy Milly]

I am tending to agree a bit more I also enjoy the discussion.

I reviewed some more elements of Annex II and it seems it allows for some cherrypicking. If it would not, it would be very difficult to address everything.

I fully agree with your last opinion - if IFU is not supplied, there are not much requirements related to the content left.

About requests for IFU: This was an (old) explanation from our CA. Maybe this was their own interpretation as I cannot find anything relevant in the MDR. IFU ("as a document") is also mentioned in Annex II, 2 (it is expected in the tech file), but as you wrote, content if the IFU is only specified for cases where IFU is supplied. Maybe this route is the reason for all shady IFUs out there

Honestly, I never dived really deep in this topic as our products require an IFU in all cases. Thank you for this.

 

[EmiliaBedelia]

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.

Agreed that for Germany in particular you may not need to translate for professional users. My point here is that the exception for safely using without an IFU (per GSPR 23.1) would not extend to the label - so there may be a reason why translation per Art. 10 is not required for a particular country, but it's not the same exemption that would apply to the IFU.

Also, the original poster never confirmed if the device is for professional users or not...so that exemption may not actually be applicable to them. The bottom line is that the OP would need to verify for individual countries whether they will accept English-only, there is no exemption for labels inherent in the regulation.

 

[RA_QA_Expert]

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.

Hello,
if you justify that you do not need IFU for your class I / IIa device, this justification must be based on risk/usability evaluation. But if you have some residual risks, or user needs to be instructed for proper device usage without user errors, such information must be provided with a device.

Any safety instructions must be in the understandable form for specified users. As guide you can use EN ISO 20417, there is also reference table between standard requiremens and GSPR's.

You can use normative symbols (e.g. based on ISO 15223-1, EN 60601-x, ...), and if the standard is harmonized with the applicable law (MDD within transitional period or MDR) you don't need to explain it.

if you have your own pictures or symbols, you need to evaluate its understandability within usabiilty process.

If you use any text, it must be translated into local language, or you must be sure and justify e.g.that medical professionals using your device have education to understand e.g. EN text. If you sell the device for home use and/or used1 by lay personell, there is no excuse, it must be in local language.

Good luck