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English translation: Act on dispensing of medical devices
17:02 Aug 24, 2014
German to English translations [PRO] Law/Patents - Medical: Health Care
German term or phrase:Abgabe von Medizinprodukten
"Verordnung über die Abgabe von Medizinprodukten und zur Änderung medizinprodukterechtlicher Vorschriften"
Title of a law that comes up in my text. Lots of googling hasn't revealed anything definitive, so far "dispensing of medical devices". TIA for your help.
Explanation: First of all: it should be distinguished between 'medical device' and 'medicinal product' (as defined by the European Union) AND 'medical product' ; and the explanation of the differences can be found here: (although 'the Wiki' is sometimes not precise enough or even not reliable (enough), the difference is explained clearly and accurately in this particular case).
(To be honest, I am not familiar enough with all the facets and the use –in particular, legal use- of "provision/provisioning" to tell whether that would be a good or a misleading choice.)
Thanks, also just thought of "provisioning" as a possible solution. The Verordnung pertains to both physicians and manufacturers, the difference now being that manufacturers can now sell directly to non-medical personnel without prescription and under certain conditions.
BfArM is the federal authority for drugs and medical devices (NB: they carry the Medizinprodukte/medical devices translation in their own name), and they use the same odd English as most any other German (medico-legal) body. Ordinance is, in my experience, the preferred official term for Verordnung, whereas regulation is used for Vorschrift (mind, this is a German "Verordnung" – EU terminology is different). Leaves you with the "outlandish" term of making available which seems to be a creation of the same mind who invented "Inverkehrbringen" and an attempt to make a distinction to the strongly regulated "dispensing" of drugs, since the purpose of this ordinance is to de-regulate the "selling" of medical devices. --> IMO, it is ok to use the BfArM translation.
should I use the BfArM title, even if it sounds odd? Impossible to say if this is an official title or a loose translation for their press release. Although I assume BfArM offered its input, the text itself comes from the Bundestag, so perhaps BfArM's take is irrelevant?.
@ Jonathan: Then I guess it doesn't help any, that when you click on the link I mentioned, the tab at the top of the screen says "Act amending the regulation...."!
Medizinprodukt bezeichnet einen Gegenstand oder einen Stoff, der zu medizinisch therapeutischen oder diagnostischen Zwecken für Menschen verwendet wird, wobei die bestimmungsgemäße Hauptwirkung im Unterschied zu Arzneimitteln primär nicht pharmakologisch, metabolisch oder immunologisch, sondern physikalisch oder physikochemisch erfolgt.
So a medical device is an example of medical products, not a synonym.
Not discounting, trying to differentiate between Verordnung and Gesetz. Most Verordnungungen seem to be referred to as "Regulations" nowadays, at least in the latest versions of German law. Or do you mean as far as "prescription" versus "dispensing" is concerned?
Not so, "medical devices" is the official German for Medizinprodukte, here a bilingual extract from the law's attachment (issed in July of this year): "Formblatt für Medizinprodukte, außer In-vitro-Diagnostika Form for Medical Devices except In Vitro Diagnostic Medical Devices"
You just have to look at the first couple of paragraphs of the regulation to see the meaning of Abgabe. And it's products, not devices, which is Geräte.
Regulation on the Dispensing of Medical Devices...
17:03 Aug 24, 2014
is as far as I have gotten.
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Answers
1 hr confidence: peer agreement (net): +1
Act on dispensing of medical devices
Explanation: First of all: it should be distinguished between 'medical device' and 'medicinal product' (as defined by the European Union) AND 'medical product' ; and the explanation of the differences can be found here: (although 'the Wiki' is sometimes not precise enough or even not reliable (enough), the difference is explained clearly and accurately in this particular case).
Jacek Konopka Poland Local time: 08:27 Native speaker of: Polish PRO pts in category: 14
Grading comment
Thanks.
22 mins confidence: peer agreement (net): +2
Statute regarding the dispensing of medical products
Explanation: It would help to have more contextual information. Abgabe in US statutes is clearly defined as dispensing as opposed to prescribing. Context will tell you whether it is medical products or medical devices or both pharmaceuticals and devices. D. Jacobson MD N.B. Context will tell you whether it is a statute or a regulation.
-------------------------------------------------- Note added at 8 hrs (2014-08-25 01:56:41 GMT) --------------------------------------------------
I've been reading on this and the closest words that I can find are provision, furnishing, or distribution for Abgabe in regard to non-pharmaceuticals
Donald Jacobson United States Local time: 01:27 Specializes in field Native speaker of: English PRO pts in category: 28
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peer agreement (net): +1
