Amendment Of The Regulation On The Classification Of Medical Devices

Original Language Title: Änderung der Verordnung über die Klassifizierung von Medizinprodukten

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247. Regulation of the Federal Minister for health, modifies the regulation on the classification of medical devices

On the basis of § 25 of the medical product law, BGBl. No. 657/1996, as last amended by Federal Law Gazette I no. 143/2009, is prescribed:

Ordinance of the Federal Minister for health on the classification of medical devices, Federal Law Gazette II No. 143/2009, is amended as follows:

1. paragraph 2:

"2. (1) in vitro diagnostic medical devices are in accordance with annex II of the Directive 98/79/EC on in vitro diagnostic medical devices, OJ No. L 331 of the 07.12.1998 p. 1, as last amended by the directive of 2011/100/EC, OJ No. L 341 of the 22nd December 2011, p. 50, the lists A and B are associated.

(2) the screening, diagnosis and tests to confirm proof of the variant of Creutzfeldt-Jacob disease (vCJD) are associated in accordance with annex II of the Directive 98/79/EC of the list A."

2. the point Z is 8 at the end of section 3 a semicolon replaced and added following Z 9:



"9 policy 2011/100/EC amending the Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices, OJ No. L 341 of the 22nd December 2011, p. 50."

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