128. 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 ° 77/2008 and the Federal Ministries Act of 2009, Federal Law Gazette (BGBl). I No 3, shall be assigned:

§ 1. For those listed in List A of Annex II to Directive 98 /79/EC on in vitro diagnostic medical devices, OJ L 327, 30.4.1998, p. No. OJ No L 331, 7. 12. 1, the in vitro diagnostic medical devices referred to in the Annex to the Commission Decision of 3 February 2009 amending Decision 2002/364/EC laying down common technical specifications for in vitro diagnostic medical devices (2009/108/EC), OJ L 136, 31.5.2009, p. No. OJ L 39/34, 10. 2. 2009 p. 34, technical specifications referred to as common technical specifications in the sense of the Medical Devices Act.

§ 2. This Regulation implements Decision 2009 /108/EC.

§ 3. (1) This Regulation shall enter into force on 1 December 2009.

(2) For in vitro diagnostic medical devices for the first time being placed on the market before 1 December 2009, this Regulation shall apply from 1 December 2010.

(3) The manufacturers shall be allowed to apply the requirements of the Annex referred to in Article 1 before the dates referred to in paragraphs 1 and 2.

(4) With the entry into force of this Regulation, the Regulation of the Federal Minister for Social Security and Generations shall enter into force on the Common Technical Specifications for in-vitro diagnostic medical devices, BGBl. II No 387/2002, except for force. For in vitro diagnostics, which will be placed on the market for the first time before 1 December 2009, the requirements of the BGBl Regulation will apply until 1 December 2010. II No 387/2002.

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