Common Technical Specifications For In Vitro Diagnostic Medical Devices 2012

Original Language Title: Gemeinsame Technische Spezifikationen für In-vitro-Diagnostika 2012

Read the untranslated law here: https://www.global-regulation.com/law/austria/2997265/gemeinsame-technische-spezifikationen-fr-in-vitro-diagnostika-2012.html

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
304. Regulation of the Federal Minister of health on common technical specifications for in vitro diagnostic medical devices

On the basis of section 11 subsection 3 of the medical devices act, Federal Law Gazette No. 657/1996, as last amended by the Federal Act Federal Law Gazette I no. 143/2009, is prescribed:

§ 1. For in annex II, list A of Directive 98/79/EC on in vitro diagnostic medical devices, OJ No. L 331 of 07 12 1998 p. 1, most recently amended by Directive 2011/100/EC, OJ No L 341 of the 22nd December 2011 p. 50, in-vitro diagnostics referred to apply that in the annex of to decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices, OJ No L 131 of the 16.05.2002 p. 17, as last amended by decision 2011/869/EC, OJ No. L 341 of the 22nd December 2011 p. 63, stated specifications as common technical specifications within the meaning of the medical product law.

§ 2. The 2011/869/EC Commission decision will be implemented by this regulation.

§ 3. With the entry into force of this regulation is the regulation of the Federal Minister of health on common technical specifications for in vitro diagnostic medical devices, Federal Law Gazette II No. 128/2009, as last amended by BGBl. II Nr 368/2010, override.

Sands