268. Ordinance of the Federal Minister of Health with the accompanying measures for the Regulation (EU) No. 722/2012 (MPTG-VO)

On the basis of § 77 (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. (1) The enforcement of Regulation (EU) No 722/2012 laying down specific requirements as regards the requirements of Directive 90 /385/EEC and/or Directive 90 /385/EEC Council Directive 93 /42/EEC on active implantable medical devices and medical devices manufactured using tissue of animal origin, OJ L 327, 30.4.1993, p. No. 3., the Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) is responsible for the application of the provisions of paragraph 2 of this article.

(2) The tasks provided for in Article 4 of Regulation (EU) No 722/2012 shall be the responsibility of the Federal Minister responsible for health care matters.

§ 2. (1) This Regulation shall enter into force on 29 August 2013.

(2) With the entry into force of this Regulation, the Regulation of the Federal Minister for Health and Women concerning requirements for medical devices of Directive 93 /42/EEC, which is produced using tissue of animal origin, shall enter into force. (MTGV), BGBl. II No 579/2003, except for force.

Stöger