INstruchemie is a family-owned business, founded in 1979 by Irenus Nieland in The Netherlands. INstruchemie started as a distributor for in vitro diagnostics with the slogan:
Science without f(r)iction
In 1986 we opened our own research and production facility and started to produce our own line of in vitro diagnostics. Through research and dedication, we grew into a company selling our products worldwide. In 2014, Fons Nieland became the managing director of INstruchemie. Nowadays we have over 40 years of experience, but our slogan has not changed. If you are looking for an in vitro diagnostic test, please do not hesitate to contact us! We will gladly help you find what you are looking for.
Quality has always been important to INstruchemie. We use a certified quality management system to ensure each batch is identical and passes strict quality control procedures. In 1997 we acquired our first ISO quality management certificate and we are currently (EN) ISO 13485:2016 certified. Additionally, all INstruchemie products are CE-marked under the Directive 98/79/EC (EU) on in vitro diagnostic medical devices. Our quality management team is currently working on complying with the new EU Regulation 2017/746 (EU) on in vitro diagnostic medical devices and are well on their way regarding the current timelines.
INstruchemie offers an extensive range of assays and control materials for spectrophotometric, (U)HPLC, and LC-MS methods which can be found full in this product catalogue. However, we also offer a wide range of product from other reputable companies, on which we will gladly provide more information. Additionally, INstruchemie is always working on improving our products and developing new IVD reagent sets. We also offer custom made options, so please feel free to contact us!
Regulation 2017/746 (EU) on in vitro diagnostic medical devices
The Regulation 2017/746 (EU) on in vitro diagnostic medical devices, or the IVDR for short, came into force on May 26, 2022 to replace the Directive 98/79/EC (EU) on in vitro diagnostic medical devices. The IVDR assured increased safety and efficiency in the EU in vitro diagnostic medical device market. Regulation (EU) 2022/112 has extended the transitional period for current IVDD products and states:
Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive, and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, may be placed on the market or put into service until the following dates:
(a) 26 May 2025, for class D devices;
(b) 26 May 2026, for class C devices;
(c) 26 May 2027, for class B devices;
(d) 26 May 2027, for class A devices placed on the market in sterile condition
For INstruchemie, a manufacturer of all class B devices, this means that all products must comply to the IVDR on May 26 2027. In the meantime, we will assure to maintain the highest product quality as possible and work towards achieving the CE-mark of the IVDR
as soon as possible but of course prior to the date required by the IVDR.
Transport and stability
Per January 1 2023 we are improving our transport conditions to ensure optimum quality of our products. INstruchemie ensures stability of the product for at least 1 week from the date of shipment.
The traceability of our calibrators and standards will in the near future be displayed in all of our instructions for use (IFU). By referencing the calibrators and standards to a reference standard of a higher order, INstruchemie ensures optimum accuracy of the patient results.
If necessary and upon request, INstruchemie offers all its customers additional support material by documenting the traceability chain with internal manufacturing documentation, such as a certificate of analysis (CoA), that precisely links the calibrator to the standard of the higher order.