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MP SicherheitsplanVO

English translation: Ordinance on Medical Devices Vigilance

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
German term or phrase:MP SicherheitsplanVO (Medizinprodukte-Sicherheitsplanverordnung)
English translation:Ordinance on Medical Devices Vigilance
Entered by: Steffen Walter

06:37 Jan 9, 2003
German to English translations [PRO]
Law/Patents - Medical (general) / Name of a German Ordinance
German term or phrase: MP SicherheitsplanVO
"2.1 Vorkomnisse (§ 2 MP SicherheitsplanVO)

This appears as a heading in a standard operating procedure about a medical devices vigilance system. Among other things, it discusses incidents, and the present paragraph is stating what exactly "incident" (Vorkommnis) means.

Obviously, this "MP SicherheitsplanVO" is a law (probably an ordinance) of some sort, but I can't find anything about it. Hoping it will ring a bell with someone here. TIA for your help.
Rowan Morrell
New Zealand
Local time: 20:38
Medical Devices Security Plan Ordinance
Explanation:
Or Security Plan Ordinance for Medical Devices

The German term is "Medizinprodukte-Sicherheitsplan-Verordnung". My translation is only a guess, since I have not found an exact English term for it.

Extract from Web site: The legal framework for medical device law in Germany has undergone a fundamental change since the second amendment of the Medical Devices Act (Medizinproduktegesetz (MPG)) took effect on 1 January 2002. Firstly, the original MPG was revised from top to bottom; numerous provisions were amended or expanded and various provisions were repealed altogether. In addition, various ordinances were created on the basis of the second amendment of the MPG, such as the Security Plan Ordinance (Sicherheitsplan-Verordnung), which will provide a more detailed structure of the medical device vigilance and reporting system
Selected response from:

lisa23
Germany
Local time: 10:38
Grading comment
Thanks very much for that. After further research of my own, I managed to find this translation on two difference sites: Ordinance on Medical Devices Vigilance. So I'm going to use that. But thank you very much for your help.
3 KudoZ points were awarded for this answer



Summary of answers provided
3Medical Devices Security Plan Ordinance
lisa23


  

Answers


29 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
Medical Devices Security Plan Ordinance


Explanation:
Or Security Plan Ordinance for Medical Devices

The German term is "Medizinprodukte-Sicherheitsplan-Verordnung". My translation is only a guess, since I have not found an exact English term for it.

Extract from Web site: The legal framework for medical device law in Germany has undergone a fundamental change since the second amendment of the Medical Devices Act (Medizinproduktegesetz (MPG)) took effect on 1 January 2002. Firstly, the original MPG was revised from top to bottom; numerous provisions were amended or expanded and various provisions were repealed altogether. In addition, various ordinances were created on the basis of the second amendment of the MPG, such as the Security Plan Ordinance (Sicherheitsplan-Verordnung), which will provide a more detailed structure of the medical device vigilance and reporting system


    Reference: http://www.google.de/search?q=cache:VnWnnRJADP8C:www.wmrc.co...
lisa23
Germany
Local time: 10:38
Native speaker of: Native in GermanGerman
PRO pts in category: 29
Grading comment
Thanks very much for that. After further research of my own, I managed to find this translation on two difference sites: Ordinance on Medical Devices Vigilance. So I'm going to use that. But thank you very much for your help.
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