Background about Labotect Certificates

In 1998, Labotect implemented a Quality Management System according to ISO 9002. In 2003, as one of the first medical device manufacturers in Germany, Labotect was certified according to DIN EN ISO 13485:2003.

ISO 13485

Contrary to the ISO 9001, the ISO 13485 certificate refers to many other rules, regulations and laws to be fulfilled (i.e. ISO/TR14969 Guidance on the application of ISO 13485, ISO 14971 Application of Risk Management for Medical devices). Its key features are the following:

  • Defined product specifications
  • Defined production process including suppliers
  • Risk Analyses
  • Biological and Clinical data for design validation
  • Product identification and traceability
  • Traceability of components

Directive 93/42/EEC

Furthermore, Labotect is certified according to the Medical Device Directive (MDD) or Directive 93/42/EEC, which is the most important regulatory instrument for the detection of safety and medical-technical performance of medical devices in the European Economic Area. The key features of Council Directive 93/42 EEC are as follows:

  • Essential requirements (safety, functionality, design, materials etc.)
  • Conformity to harmonized standards
  • Classification
  • Conformity assessment procedures
  • Registration of responsible persons
  • Unannounced audits by the notified body with at least two auditors for one day (at least once in a three year period)


All our products have a CE-label, which claims, that this product conforms to the correspondent EC regulation and all essential requirements are met. The CE-label is mandatory for all medical devices and allows the access to the complete EC market.

Scope of ISO certificates

As many users do not have in focus, the scope of the ISO certificate is defined by the manufacturer before the certification process, and thus makes a big difference.

The scope of Labotects ISO-certificate:

“Design and development, production, sale and service of sterile products, sterile medical products and medical products (intrauterine catheters, biopsy needles and sets for ultrasonic aspiration, micropipettes) for assisted reproduction and for cell and tissue cultures; Installation, maintenance and repair of laboratory equipment and active medical products in addition to logistics services”

You may compare this to the scope of competitor’s ISO-certificates.

Please make sure to check the certificates, the scope of those and, if need be, the notified body prior to your buying decision!