Quality management
Quality Management
Quality starts with putting customer satisfaction at the centre of all considerations
Intensive dialogue with our international customers is a prerequisite for acting in line with market and using state-of-the-art technology. We analyse the needs of our customers and initiate industry trends and innovations that help improve healthcare worldwide.
Top Performances achieve targets
Since our products are used directly on patients and in the most modern research and development laboratories, they must conform to the highest safety, precision and hygiene standards. As a global company, we can ensure that our products meet the statutory and official regulations of various countries and markets.Against this background, SARSTEDT has introduced an integrated Quality Management (QM) system. It is based on the international standard EN ISO 13485. Independent bodies regularly monitor and certify compliance with standards.
IVDR-certified quality – for safe, precise solutions
SARSTEDT is gradually transitioning its IVD product portfolio to the requirements of the IVDR.
Since May 2022, all non-sterile Class A IVD products have met the requirements of the IVDR. For sterile Class A IVD products (Class As), the first IVDR certification of representative product groups, including S-Monovettes, was completed at the end of 2024. In 2025, certification was extended to the entire Class As IVD product segment.
In September 2026, the IVDR certification for SARSTEDT was successfully renewed following the change of Notified Body from DEKRA Certification GmbH to DEKRA Certification B.V. This provides the basis for the continued supply of our sterile Class A IVD products.
What does this mean for labelling?
The gradual transition to IVDR-compliant labelling will begin in the coming months. Until the respective transition is completed, the products concerned will continue to be placed on the market under the IVDD in accordance with the applicable IVDR transitional provisions.
For sterile Class A IVD products, including S-Monovettes, the corresponding transitional period applies until 31 December 2029.
Which regulatory status applies to my product?
The applicable regulatory status of a product – IVDD or IVDR – is stated in the corresponding EU Declaration of Conformity. These declarations are available on the respective product page under “Downloads” and centrally on our “Declarations of Conformity” page.
MDR-certified quality – for future-ready solutions
All SARSTEDT medical devices have been certified under the Medical Device Regulation (MDR) since April 2023 and have been marketed as MDR-compliant since September 2023. We chose not to use the extended deadline, which allows Class Is and IIa medical devices to be marketed under the MDD certificate (Directive 93/42/EEC) until the end of 2028. Instead, we proactively took all necessary steps to ensure the highest standards of safety and quality, as well as uninterrupted availability.
Our claim: care and safety
In order to ensure the highest possible level of quality, we pursue various different strategies at all levels. In doing so, we always use state-of-the-art production facilities and high-quality raw materials. We always guarantee a consistently high level of quality by using standardised processes and constantly monitoring and analysing these.In addition, we have developed our own seals of quality. For example, the label "Biosphere® plus" is a purity standard for laboratory products. Additionally, our other certifications "PCR Performance Tested", "TC Tested" and "Cryo Performance Tested" document our guarantees for purity and highest quality.SARSTEDT quality means meeting the highest requirements.
Information for Distributors – Compliance with Article 14 MDR/IVDR
In accordance with the requirements of Article 14 of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic devices (IVDR), we inform all distributors of their obligations regarding the verification, documentation, and traceability of the products placed on the market.
It is of central importance that our distributors are familiar with, understand, and consistently implement the relevant legal requirements in order to ensure patient safety, regulatory compliance, and continuity of the supply chain.
Please refer to the attached information letter for detailed information on the specific distributor obligations under the MDR and IVDR.