BioScience

Quality Assurance BioScience Division

As a supplier of high-quality products for medical research and a manufacturer of diagnostic devices, we are responsible for countless analyses carried out with our products in research institutes, laboratories and hospitals all over the world.
Our products and processing methods are continually improved by using only the latest machinery and tools, applying state-of-the-art technologies and carrying out high-tech manufacturing under specific conditions. We only process raw materials of the highest quality. This corporate philosophy has lead to the high accuracy and reliability our BioScience products are known for.

Quality Standard According to DIN EN ISO 9001

For us, the confidence our customers have been placing in us for more than 30 years is ample proof of our high quality standard and constitutes a commitment on our part to continue improving the quality of our products in the future.
Greiner Bio-One / BioScience was one of the first manufacturers in this industrial sector to receive the DIN EN ISO 9001 certification from the Bureau Veritas Quality International in 1994. The certification renewals in 1997 and 1999 are additional proof of the high standard of the manufacturing processes, quality control and organisation of our company, and we have ISO 9001:2000 certification since 2003.

CE labelling, EU Directive 98/79/EC Concerning In-Vitro Diagnostic Medical Devices

1) EU Directive 98/79/EC

The new EU Directive 98/79/EC concerning in-vitro diagnostic medical devices was published in December 1998. The requirements of this Directive need to be incorporated into the national legislation of the EU member countries. All products considered to be in-vitro diagnostic medical devices according to the Directive must be identified by a CE label in order to be distributed in the EU member countries. The CE label indicates that the product is in compliance with the Directive.

Directive 98/79/EC was established in addition to already existing directives covering the large medical device sector. The new Directive thereby extends the medical device field by adding the sector of in-vitro diagnostic medical devices. The content of the new Directive closely complies with the content of the already existing directives on medical devices in order to maintain the standardisation of EU guidelines.

Since the new Directive applies to a number of our products, the Directive guidelines have to be complied with for these products. The compliance is corroborated by a declaration of conformity as well as the CE labelling.

2) Classification of in-vitro diagnostic medical devices (=IVD)

Due to different regulation requirements, IVDs are classified as follows:

1. Devices according to Annex II, List A

2. Devices according to Annex II, List B

3. Devices for self-testing (intended to be used by a layperson in a domestic environment)

4. Devices for performance evaluation purposes (intended for performance evaluation purposes e.g. for medical analyses in laboratories)

5. All other devices which are considered to be IVDs

3) Some basic requirements

Irrespective of their classification, all IVDs must be in compliance with a number of basic safety, performance and specific labelling requirements. These requirements are listed in detail in Annex I of the 98/79/EC Directive. IVDs must be manufactured in compliance with a quality assurance system. According to Annex III of the Directive, a technical documentation needs to be created for each IVD, and the manufacturer must be registered with the appropriate authority.

Different conformity evaluation procedures may be selected according to additional EU Directives. The involvement of a notified body is required for IVDs of Annex II and for self-testing devices (see classification 1, 2 and 3). For performance evaluation devices as well as all other devices (classification 4 and 5), the manufacturer is able to autonomously carry out the conformity evaluation procedure according to Annex III.

4) Transitional regulations

The CE labelling of in-vitro diagnostic medical devices according to directive 98/79/EC has been an option since June 7, 2000. From December 7, 2003 onwards, all in-vitro diagnostic medical devices will have to be identified with a CE label before they can be distributed in EU member countries.

Any of our products affected by 98/79/EC Directive shall be identified with a CE label from December 7, 2003 onwards.