Information supplied by the manufacturer of medical devices; German version EN 1041:2008+A1:2013
German title
Bereitstellung von Informationen durch den Hersteller von Medizinprodukten; Deutsche Fassung EN 1041:2008+A1:2013
Publication date
2013-12
Original language
German
Pages
32
Publication date
2013-12
Original language
German
Pages
32
DOI
https://dx.doi.org/10.31030/2065052
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Overview
This standard (EN 1041:2008+A1:2013) contains the amendments to EN 1041:2008 which have been prepared by Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices". The responsible German committee is NA 063-01-13 AA "Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte" ("Quality management and corresponding general aspects for medical devices") at the Medical Standards Committee, NAMed. The amendment mainly contains specifications regarding the provision of information required in clause 5, and an update of the Bibliography.
Please get in touch with the relevant contact person at DIN if you have problems understanding the content of the standard or need advice on how to apply it.