Two years of IVDR: membraPure draws a positive first conclusion for itself and the users of its amino acid analyzers.

(Hennigsdorf, 05.06.2024)

Amino acid analysis is still an important component of modern diagnostics. State-of-the-art amino acid analyzers such as the ARACUS continue to be used in a wide variety of areas, from medicine and research to the food industry, and deliver valid results. However, this also increases the demands on the systems used, which is particularly evident in the regulatory provisions for medical applications: Whereas the IVDD (Directive 98/79/EC) used to apply, the IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) came into force on May 26, 2022 after a five-year transition period, which requires certification according to risk classes for in vitro diagnostic products. The ARACUS IVD classic and IVD advanced amino acid analyzers have already been certified for IVDR risk class A since 2022 and are successfully in use in Germany.

The IVDR therefore places higher requirements on the products and their manufacturers – and therefore additional work. However, two years after the IVDR came into force, those responsible at membraPure can say that the extra effort has paid off in many respects: for the work in the laboratory, for the global market opportunities for European medical devices and, above all, for patients thanks to the guaranteed high quality of the analyses.

Dr. Jessica Walkowiak, Head of Laboratory:

“Certification has brought structural changes: in some cases, processes take longer because more quality steps have to be completed. However, our experience to date shows that these have now been very well integrated into everyday laboratory work. However, these additional requirements also make processes more comprehensible and safer. This is definitely a quality gain, even for non-medical products.”

Dr. Erdmann Flindt, Managing Director of membraPure:

“We were the first to achieve this certification for these devices. The fact that we were pioneers also helped to convince customers to choose us. It is a nice confirmation of our work that our devices are successfully in use and shows that the step to seek IVDR certification was the right one. In addition to medical users, users from the food sector and research can of course also benefit from the advantages of our high-precision analyzers.”

Dr. Carsten Stollfuß, COO membraPure:

“It’s almost par for the course to complain about new regulations, but at this point I have to say clearly: the IVDR is a win-win situation for all sides. Product certification gives users peace of mind. And because our amino acid analyzer has this certification, users opt for it. This justifies the effort for us and we also learn from it for other certifications. For example, when it comes to certifying our devices for markets outside the EU, I see clear synergy effects.”