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227. Regulation of the Federal Minister for Economic Affairs, Family and Youth on the accreditation of the medical device testing centre Graz for the certification of management systems
Due to § 17 para. 1 and § 38 Z 1 of the Accreditation Act, BGBl. No. 468/1992, as last amended by Federal Law BGBl. I n ° 85/2002, shall be assigned in agreement with the Federal Minister for Health:
§ 1. The test centre for medical devices Graz, headquared in 8010 Graz, Kopernikusgasse 24, will be the body responsible for the management systems (according to ÖVE/ÖNORM EN ISO/IEC 17021). 1 ) Certified, accredited.
§ 2. The certification authority includes the certification of management systems in subsequent areas
| 1. |
Quality management systems according to ÖNORM EN ISO 9001 2 in accordance with the Annex specified scope, |
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| 2. |
Quality management systems for medical devices according to ÖNORM EN ISO 13485 3 , |
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| 3. |
within the scope of the EU Directive 93 /42/EEC 4 in the current version, implemented in Austria by BGBl. No. 657/1996 5 in the current version |
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| Product/Product Group |
Conformity assessment procedures |
| Active medical devices (including their accessories) |
Annex II (complete quality assurance system) Annex V (Production quality assurance) Annex VI (Quality Assurance Product) |
| 4. |
within the scope of the EU Directive 90 /385/EEC 6 in the current version, implemented in Austria by BGBl. No 657/1996 in the current version |
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| Product/Product Group |
Conformity assessment procedures |
| Active implantable Medical products (including their accessories) |
Annex 2 (complete quality assurance system) Annex 5 (Production quality assurance) |
§ 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.
Mitterlehner
