Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are getting conflicting advice on whether or not medical device labeling must be translated into Irish. According to S.I. No. 547/2017 - European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 - in section 5. For the purposes of- (a) Articles 10(11) and (14), 11(3)(d), 18(1), 19(1), 41, 52(12), 56 and 89(8) of Regulation (EU) 2017/745, and (b) Articles 10(10) and (13), 11(3)(d), 17(1), 37, 48(11), 51 and 88(8) of Regulation (EU) 2017/746, the language determined by the State is the English language or both the Irish language and the English language.

However, with the Irish language now on equally footing as of Jan. 1, 2022 as an official EU language - many device manufacturers are unsure if this new status trumps the previously referenced rule. It is our understanding that Irish is not required unless specifically requested for labeling. I'd love to know what others are seeing on this front. THANKS!

Hello Anon,

Having spent quite a bit of time in Ireland, the Irish are keen on language equality in Ireland for inclusion of both English and Irish (Gaelic) - HPRA even says it on their website about language equality.  (I find it quite interesting to watch RTE/TG4 on TV but I have no idea what they are saying haha.)  I have discussed this in the past with people and there is a sense of professional use devices would be fine in English language.  Products which are for lay-person - Over The Counter (OTC) - there is a keen awareness to have in both English and Irish.  Depending on the device, I would recommend looking at both as possibility and writing a rationale for why only English is used for products destined for Ireland.  I do not have any personal instances where products were not accepted for not having both languages available for the labelling.  There are a few individuals in this forum from Ireland maybe who may have more direct experience.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Jan-2023 16:00
From: Anonymous Member
Subject: Irish Language Requirement for Device Labeling

This message was posted by a user wishing to remain anonymous

We are getting conflicting advice on whether or not medical device labeling must be translated into Irish. According to S.I. No. 547/2017 - European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 - in section 5. For the purposes of- (a) Articles 10(11) and (14), 11(3)(d), 18(1), 19(1), 41, 52(12), 56 and 89(8) of Regulation (EU) 2017/745, and (b) Articles 10(10) and (13), 11(3)(d), 17(1), 37, 48(11), 51 and 88(8) of Regulation (EU) 2017/746, the language determined by the State is the English language or both the Irish language and the English language.

However, with the Irish language now on equally footing as of Jan. 1, 2022 as an official EU language - many device manufacturers are unsure if this new status trumps the previously referenced rule. It is our understanding that Irish is not required unless specifically requested for labeling. I'd love to know what others are seeing on this front. THANKS!

This message was posted by a user wishing to remain anonymous

Thanks for your input Richard!
Original Message:
Sent: 16-Jan-2023 05:19
From: Richard Vincins
Subject: Irish Language Requirement for Device Labeling

Hello Anon,

Having spent quite a bit of time in Ireland, the Irish are keen on language equality in Ireland for inclusion of both English and Irish (Gaelic) - HPRA even says it on their website about language equality.  (I find it quite interesting to watch RTE/TG4 on TV but I have no idea what they are saying haha.)  I have discussed this in the past with people and there is a sense of professional use devices would be fine in English language.  Products which are for lay-person - Over The Counter (OTC) - there is a keen awareness to have in both English and Irish.  Depending on the device, I would recommend looking at both as possibility and writing a rationale for why only English is used for products destined for Ireland.  I do not have any personal instances where products were not accepted for not having both languages available for the labelling.  There are a few individuals in this forum from Ireland maybe who may have more direct experience.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 13-Jan-2023 16:00
From: Anonymous Member
Subject: Irish Language Requirement for Device Labeling

This message was posted by a user wishing to remain anonymous

We are getting conflicting advice on whether or not medical device labeling must be translated into Irish. According to S.I. No. 547/2017 - European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 - in section 5. For the purposes of- (a) Articles 10(11) and (14), 11(3)(d), 18(1), 19(1), 41, 52(12), 56 and 89(8) of Regulation (EU) 2017/745, and (b) Articles 10(10) and (13), 11(3)(d), 17(1), 37, 48(11), 51 and 88(8) of Regulation (EU) 2017/746, the language determined by the State is the English language or both the Irish language and the English language.

However, with the Irish language now on equally footing as of Jan. 1, 2022 as an official EU language - many device manufacturers are unsure if this new status trumps the previously referenced rule. It is our understanding that Irish is not required unless specifically requested for labeling. I'd love to know what others are seeing on this front. THANKS!