304. Ordinance of the Federal Minister of Health on Common Technical Specifications for in-vitro diagnostic medical devices

On the basis of § 11 (3) of the Medical Devices Act, BGBl. No. 657/1996, as last amended by the Federal Law BGBl. I n ° 143/2009, shall be:

§ 1. For the Annex II List A Directive 98 /79/EC on in vitro diagnostic medical devices, OJ L 98, 9.4.1998, p. No. OJ No L 331, 07. 12. 1, as last amended by Directive 2011 /100/EU, OJ L 206, 22.7.2011, p. No. OJ L 341, 22.12.2011 p. 50, the in-vitro diagnostic medical devices referred to in Annex to Decision 2002 /364/EC on common technical specifications for in vitro diagnostics, OJ C 327, 28.4.2002, p. No. 17, as last amended by Decision 2011 /869/EU, OJ L 131, 5.6.2011, p. No. 63., the technical specifications referred to as the Common Technical Specifications in the sense of the Medical Devices Act.

§ 2. This Regulation implements the Commission Decision 2011 /869/EU.

§ 3. With the entry into force of this Regulation, the Regulation of the Federal Minister of Health on Common Technical Specifications for in-vitro diagnostic medical devices, BGBl, enters into force. II No 128/2009, as last amended by BGBl. II No 368/2010, except for force.

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