Medical device label language requirement online EU webshop

[DannyVerbiest]

Hi,
If a medical device manufacturer located in EU is selling its OTC medical devices online. Does the medical device packaging and IFU still need to comply to the local national requirements?
Eg. our label and instructions is in english. If a customer wants to buy this from our webshop and wants to ship it to germany. Do we still need to comply to the german requirments?

 

[DallasThomasIQVIA]

@DannyVerbiest, there was recently a new guidance document released titled "MDR - language requirements for manufacturers (January 2024)" and you can look that up. It has different requirements on a country by country basis for EU Member states. For example for Germany as you cite above, it says that for labeling / instructions for use to be directed the lay user / general public then the Labeling & Instructions need to be in the German language. However if the device is intended for professional users such as clinicians / health practitioners / medical doctors that either German or English language is acceptable for the IFU / instructions for use. Hope that helps. The document I quoted above shows each country and the requirements for each.

 

[Vetty007]

In general the official language(s) of a country is required, in some cases english is allowed for prof. Users. But in Germany, also if this is the case, I know that authorities was complaining that the label has to be in German, despite prof. Users. But this could also depend on the art of medical device..... Also note, that there are sometimes additional regulations needs to be taken into account.

 

[DutchMarten]

Yes, as it is your webshop and you are shipping it to, for instance Germany, you are putting it on the market there which means you have to comply and provide the IFU in the locally required language. It would work the same with a distributor, by the way, but then it should be the manufacturer that has an agreement with the distributor or importer about which countries/markets they service and it is then up to the distributor to stick to that.

 

[DannyVerbiest]

In general the official language(s) of a country is required, in some cases english is allowed for prof. Users. But in Germany, also if this is the case, I know that authorities was complaining that the label has to be in German, despite prof. Users. But this could also depend on the art of medical device..... Also note, that there are sometimes additional regulations needs to be taken into account.

Thanks vetty!
About the additional local regulations. Do you happen to know where I can find a overview in english? When looking on the Bfarm website, I only find the national legislation in german.

 

[Vetty007]

Regarding this national things, this is a general problem as they often have a national medical device implementation act, but this is less was I meant and I was rather thinking about regulations, that could additionally target a device, e.g. if the device also falls under the chemical law, then there are also language labelling requirements.

 

[DutchMarten]

Thanks vetty!
About the additional local regulations. Do you happen to know where I can find a overview in english? When looking on the Bfarm website, I only find the national legislation in german.

See this link.

 

[katapult]

The link of Marten is not working for me, but I guess the reference should have gone to:
EU Language Requirements
It also contains references on the national laws applicable, if any.

 

[DutchMarten]

The link of Marten is not working for me, but I guess the reference should have gone to:
EU Language Requirements
It also contains references on the national laws applicable, if any.

Yes that's the one. They probably changed the url or something.