65. Ordination of the Federal Minister of Economics and Labour on the accreditation of TÜV AUSTRIA SERVICES GMBH for the certification of management systems

On the basis of § 17 (1) of the Accreditation Act, BGBl. N ° 468/1992, as last amended by the Federal Law BGBl. I No 85/2002, shall be assigned:

§ 1. TÜV AUSTRIA SERVICES GMBH, headquartered in 1015 Vienna, Krugerstraße 16, is accredited as a body that certifies management systems (according to ÖNORM/ÖVE EN 45012).

§ 2. The certification authority includes the certification of management systems in the following areas:

1.		Certification of management systems for medical devices according to ÖNORM EN ISO 13485
2.		Within the scope of the EU Directive 90 /385/EEC idgF in Austria implemented by the Medical Devices Act-MPG, BGBl. N ° 657/1996 idgF

Product/Product Group	Conformity assessment procedures
All active implantable medical devices including their accessories	Appendix 2-Full QM System Annex 5-QM-System Production

3.		In the scope of the EU Directive 93 /42/EEC idgF in Austria implemented by the Medical Devices Act-MPG, BGBl. N ° 657/1996 idgF

Product/Product Group	Conformity assessment procedures
All medical devices, including their accessories are excluded: -Weichteilimplantate -Neurosurgical and neurological implants -Cardiovascular implants	Annex II-complete QM system Annex V-QM-System Production Appendix VI-QM-System Product

4.		Within the scope of the EU Directive 98 /79/EC idgF in Austria implemented by the Medical Devices Act-MPG, BGBl. N ° 657/1996 idgF

Product/Product Group	Conformity assessment procedures
All IVD products including their accessories	Annex IV-Full QM system Annex VII-QM-System Production

5.		In the scope of the EU Directive 2000 /9/EC idgF in Austria implemented by the ropeway law 2003-SeilbG 2003, BGBl. I No 103/2003 idgF

Product/Product Group	Conformity assessment procedures
Safety components	Annex V-Conformity assessment, or Section 7 rope bG 2003; module H

§ 3. The certification authority applies to those areas in which the Federal Government is responsible for legislation and enforcement, provided that the federal laws governing these areas do not comply with the provisions of the Accreditation Act relating to the accreditation of such bodies.

§ 4. With the entry into force of this regulation, the Federal Minister of Economics and Labour's Regulation on the accreditation of the TÜV Austria for the certification of management systems, BGBl, is to be taken. II No 20/2006, except for force.

Bartenstein