Jonathan MacKerron (asker) Aug 25, 2014:

Will propose several versions to the client and let them decide - thanks for all your input!

Anne Schulz Aug 25, 2014:

(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.)

Jonathan MacKerron (asker) Aug 25, 2014:

@Anne 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.

Anne Schulz Aug 25, 2014:

FWIW 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.

Merry Foxworth Aug 25, 2014:

application instead of dispensing???? Again, dispensing in English is usually used with pharmaceuticals, not with medical devices.

philgoddard Aug 24, 2014:

"Making available" is poor translation. I hope most people here agree that however you translate Medizinprodukten, Abgabe means dispensing.

Jonathan MacKerron (asker) Aug 24, 2014:

Now I'm even more confused, 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 MacKerron (asker) Aug 24, 2014:

@Wendy Yes, thanks.

Jonathan MacKerron (asker) Aug 24, 2014:

Just found this more or less from the horse's mout http://www.bfarm.de/EN/MedicalDevices/clinTrials/_node.html

"Ordinance on the Making Available of Medical Devices and amending the Regulations governing Medical Devices"

But probably just a 'loose' interpretation.

Wendy Streitparth Aug 24, 2014:

@ 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...."!

Jonathan MacKerron (asker) Aug 24, 2014:

@Wendy One translation of the MPG calls "Abgabe" "the making available of", but a bit too long-winded for my tastes.

philgoddard Aug 24, 2014:

Wikipedia says 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.

Jonathan MacKerron (asker) Aug 24, 2014:

@Wendy 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?

Wendy Streitparth Aug 24, 2014:

@ Jonathan: I assume you're discounting The Medical Devices Act.
http://www.bmg.bund.de/fileadmin/dateien/Downloads/Gesetze_u...

Jonathan MacKerron (asker) Aug 24, 2014:

see BfArM website " Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM)"

Jonathan MacKerron (asker) Aug 24, 2014:

@Phil 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"

Even their drug regulating agency bears the name:
http://www.bfarm.de/EN/Home/home_node.html;jsessionid=EFFEBA...
Medicinal products = Arzneimittel

"Medizinprodukt ( Erstmaliges Inverkehrbringen) /
Medical device (First placing on the market)"

philgoddard Aug 24, 2014:

Jonathan 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.

Jonathan MacKerron (asker) Aug 24, 2014:

Thanks but definitely "medical devices" according to the BfArM and the German Bundestag.

franglish Aug 24, 2014:

Dispensing of Medicinal Products googles well, and is what I believe is meant here.

Jonathan MacKerron (asker) Aug 24, 2014:

Regulation on the Dispensing of Medical Devices... is as far as I have gotten.