Jan 22, 2019

BSI、欧州MDRの下で指定された最初の公認機関に

EMERGO by UL このニュースのポイント BSI UKは、NANDOに指定されています。 この機関は、BSI NLをサポートしていません。 他の公認機関はまもなく従う予定です。 新しい医療機​​器規制(EU)2017/745は、現行の医療機器指令93/42 / EEC(MDD)および能動埋込み型医療機器指令90/382 / EEC(AIMDD)を更新したものではありません。すべての機器は 再度...
Feb 21, 2013

Gesetzesentwurf zur Klassifizierung von Medizinprodukten in Peru veröffentlicht

Die Dirección General de Medicamentos, Drogas e Insumos (DIGEMID), die in Peru für den Medizinproduktemarkt zuständige Behörde, hat einen
Feb 13, 2013

Draft Regulations on Device Classification Published in Peru

The Dirección General de Medicamentos, Drogas e Insumos (DIGEMID), Peru’s medical device market regulator, has published draft regulations to overhaul the country’s device classification system.
Jan 17, 2013

Neue Vorschriften zur elektronischen Kennzeichnung von Medizinprodukten in Europa treten im März 2013 in Kraft

Neue elektronische Kennzeichnungsvorschriften der Europäischen Kommission werden am 1. März 2013 in Kraft treten. Diese...
Jan 16, 2013

New EU Electronic Labeling Rules for Medical Devices Coming in March 2013

This regulation outlines how Instructions for Use may be provided in electronic format to professional users for certain medical devices under the Medical Device Directive and Active Implantable Medical Device Directive.
Oct 23, 2012

Overview of new medical device regulations in Europe

The long awaited proposed Regulations for medical devices (and active implantable medical devices) and IVDs...
Feb 13, 2012

Tighter EU Regulatory Controls Proposed following PIP Controversy

European Union member states should take immediate steps to
Nov 28, 2011

Eucomed Proposed EU Regulatory Fixes

European medical technology trade association Eucomed has issued a new position paper advocating six major...
Sep 28, 2011

Eleven Notified Bodies Sign On to Code of Conduct

A voluntary code of conduct for European Notified Bodies appears to be gaining traction following the document’s publishing in early 2011. Medtechinsider.com reports that eleven Notified Bodies have now signed the code of conduct ahead of a highly anticipated recast of the European Medical Devices Directive.
Apr 18, 2011

BVMed Annual Report: Healthy Returns, but Stronger Regulatory Support for Innovation Needed

In its latest annual report , German medical device industry trade group BVMed (Bundesverband Medezintechnologie)...

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