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Verantwortlicher (here)

English translation: person responsible for (first) placing on the market

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02:51 Jan 10, 2003
German to English translations [PRO]
Law/Patents / Medical Devices Vigilance System
German term or phrase: Verantwortlicher (here)
"Der Sicherheitsbeauftragte für Medizinprodukte der Unternehmen X AG unterstützt den Sicherheitsbeauftragten für Medizinprodukte des Verantwortlichen für das erstmalige Inverkehrbringen im EWR bei dessen Bewertung. Die Anzeige von Vorkommnissen bei den Behörden erfolgt durch den Verantwortlichen für das erstmalige Inverkehrbringen im EWR ebenso die Bearbeitung der Meldung."

From a medical company's SOP (standard operating procedure) about reporting incidents or near incidents as part of medical devices vigilance. Right now they're talking about what happens if the company is not responsible for circulating the device initially in the EEA, but a co-distributor is.

Verantwortlicher as an adjectival noun is always a word I struggle with. It seldom seems to translate neatly into English. Here I'm really stuck, because I don't know whether to say "responsible party", "responsible company" or maybe even "responsible person". Actually, if there is any way to get away from "responsible" and substitute something else, I'd appreciate it!

TIA for helping lift the fog that seems to be over this word for me.
Rowan Morrell
New Zealand
Local time: 19:39
English translation:person responsible for (first) placing on the market
Explanation:
You're in real EU country here so there's no getting away from this kind of English which has been adopted into the laws of the UK and Ireland where such matters are concerned.

See the UK Medical Devices Regulation (might be of use to you anyhow)

"Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep available the technical documentation referred to in Section 6.3 of Annex II or Section 7.4 of Annex III shall fall upon the person responsible for placing on the market the device to which the documentation relates or upon the importer referred to in Section 13.3(a) of Annex I"
http://www.hmso.gov.uk/si/si1994/Uksi_19943017_en_2.htm

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Note added at 2003-01-10 16:24:08 (GMT) Post-grading
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post-grading
>>>>though I\'m still wondering if \"Verantwortlicher\" is not referring to an entity<<<<
yes, for these purposes a \"person\" can be either \"natural\" or \"legal\"
Selected response from:

Per Incuriam
Grading comment
Thank you very much indeed for that Per. This fits my context very nicely (though I'm still wondering if "Verantwortlicher" is not referring to an entity in at least one instance). I must say, there's some room for improvement in EU English, but mine is not to reason why. If that's the way it's expressed, that's what I need to use. Thanks once again - really appreciate your help.
4 KudoZ points were awarded for this answer

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Summary of answers provided
4the person in charge
swisstell
4person responsible for (first) placing on the marketPer Incuriam
2unit responsible or co-distributor
Terry Gilman


Discussion entries: 1





  

Answers


31 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
the person in charge


Explanation:
to get out of the responsible aspects, and if you do not like "person" you can go for
- the executive or officer in charge

swisstell
Italy
Local time: 09:39
Native speaker of: German
PRO pts in pair: 3377
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44 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
person responsible for (first) placing on the market


Explanation:
You're in real EU country here so there's no getting away from this kind of English which has been adopted into the laws of the UK and Ireland where such matters are concerned.

See the UK Medical Devices Regulation (might be of use to you anyhow)

"Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep available the technical documentation referred to in Section 6.3 of Annex II or Section 7.4 of Annex III shall fall upon the person responsible for placing on the market the device to which the documentation relates or upon the importer referred to in Section 13.3(a) of Annex I"
http://www.hmso.gov.uk/si/si1994/Uksi_19943017_en_2.htm

--------------------------------------------------
Note added at 2003-01-10 16:24:08 (GMT) Post-grading
--------------------------------------------------

post-grading
>>>>though I\'m still wondering if \"Verantwortlicher\" is not referring to an entity<<<<
yes, for these purposes a \"person\" can be either \"natural\" or \"legal\"


Per Incuriam
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 101
Grading comment
Thank you very much indeed for that Per. This fits my context very nicely (though I'm still wondering if "Verantwortlicher" is not referring to an entity in at least one instance). I must say, there's some room for improvement in EU English, but mine is not to reason why. If that's the way it's expressed, that's what I need to use. Thanks once again - really appreciate your help.
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49 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5
unit responsible or co-distributor


Explanation:
You have my sympathy in your struggle. "Responsibles" as a plural noun (like 'my (direct) reports') is spreading.

What stands in the way of referring to the 'Verantwortliche' as the 'co-distributor'?



Terry Gilman
Germany
Local time: 09:39
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 212
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