247. Regulation of the Federal Minister of Health, amending the Regulation on the classification of medical devices
On the basis of § 25 of the Medical Devices Act, BGBl. No. 657/1996, as last amended by the Federal Law BGBl. I n ° 143/2009, shall be:
The regulation of the Federal Minister of Health on the Classification of Medical Devices, BGBl. II No 143/2009, shall be amended as follows:
1. § 2 reads:
" § 2. (1) In vitro diagnostics shall be carried out in accordance with Annex II to Directive 98 /79/EC on in vitro diagnostic medical devices, OJ L 206, 22.7.1998, p. No. 1, as last amended by Directive 2011 /100/EU, OJ L 327, 28.11.2011, p. No. OJ L 341, 22.12.2011, p. 50, lists A and B.
(2) Tests for blood screening, diagnosis and confirmation of the detection of variant Creutzfeldt-Jacob-Disease (vCJK) shall be assigned to list A in accordance with Annex II to Directive 98 /79/EC. "
2. The point at the end of § 3 Z 8 shall be replaced by a stroke point and the following Z 9 shall be added:
Directive 2011 /100/EU amending Directive 98 /79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices, OJ L 136, 31.5.2011, p. No. OJ L 341, 22.12.2011, p. 50.