IVD Directive – Importance in Amino Acid Analysis

Two Years of IVDR – A Positive Assessment

Amino acid analysis is an essential part of modern diagnostics. State-of-the-art amino acid analyzers like ARACUS are used in various fields, including medicine, research, and the food industry, as well as quality control, delivering reliable results.

As their importance grows, so do the requirements for these systems. This is especially evident in the medical field, where regulatory requirements play a significant role. Often, these regulations affect laboratory and medical technology, including their components and consumables.

Previously, the IVDD (Directive 98/79/EC) applied. Since May 2022, the IVDR (EU Regulation for In Vitro Diagnostics) 2017/746 has been gradually replacing it. This new regulation mandates certification for in vitro diagnostic products based on risk classifications.

How does membraPure GmbH, as a manufacturer and distributor, handle these changes?

“Our ARACUS classic and advanced amino acid analyzers are certified as Class A devices. Since August 2022, they have been IVDR-approved and are successfully in use in Germany,” explains Dr. Jessica Walkowiak, Laboratory Manager and Quality Management Officer. “For the Eluent Kit, we are aiming for a Class B classification. The transition period until May 26, 2027, gives us enough time to achieve this.”

There are different levels of certification and classification for IVD products, which depend on their specific application. Our Eluent Kit is designed for the "detection of free amino acid homocysteine, determination of concentration, and amino acid profile in human blood and urine." This is performed as part of medical diagnostics.

According to Directive 98/79/EC, the Eluent Kit is classified as "Other IVD," meaning it cannot be used in the EU for the detection of phenylketonuria (PKU). “This exclusion will remain because a different classification would require additional documentation and proof,” explains Dr. Walkowiak. “We had considered extending documentation to achieve a higher classification, but the cost-benefit ratio does not currently justify this step.”

Two years after the IVDR was introduced, membraPure draws a positive conclusion. While IVDR imposes higher requirements on products and manufacturers, it also adds value. The company sees the additional effort as worthwhile.

Our amino acid analyzers are successfully used worldwide in in vitro diagnostics. In Germany, there are systems in two different laboratories specializing in holistic and innovative medicine. These labs go beyond traditional diagnostic approaches. Amino acid analysis complements assessments of heavy metal content in blood, electrolytes, mineral levels, vitamins, and fatty acids. The results are combined into a holistic diagnostic report.

Dr. Jessica Walkowiak, Laboratory Manager:

“The certification brought structural changes. Some processes take longer because more quality control steps are required. However, our experience shows that these changes have now been well integrated into daily lab operations. These additional requirements make processes more transparent and secure. This is a definite quality gain, even for non-medical products. The consistent implementation of regulations leads to continuous improvement in internal processes!” reports Dr. Walkowiak with satisfaction.

Dr. Erdmann Flindt, CEO of membraPure:

“We were the first to achieve certification for these devices. Being pioneers in this area has helped us convince customers. The fact that our devices are successfully in use confirms that pursuing IVDR certification was the right decision. Besides medical users, customers in the food sector and research also benefit from the high precision of our analyzers.”

Dr. Carsten Stollfuß, COO of membraPure:

“Complaining about new regulations is common, but in this case, IVDR is a win for all parties. Product certification gives users confidence. Because our amino acid analyzer is IVDR-certified, customers choose it over alternatives. This justifies the effort, and we also gain valuable insights for future certifications. When it comes to certifying our devices for markets outside the EU, I see significant synergy effects.”

Dr. Thorsten Heinlein, Area Sales Manager at membraPure:

“In my role, I oversee the European market, where certification is not just a requirement but also a key to opening doors. For our two German customers, certification was crucial in their decision-making process. Administrative processes have become significantly easier, reducing bureaucratic efforts and simplifying work for customers.

Additionally, a project outside the European Union—specifically in Ethiopia—was successfully implemented, where IVD certification played a decisive role. This shows that countries outside Europe are increasingly adopting European standards. The coming years will be exciting. This trend will continue to gain importance. IVDR not only optimizes internal processes and improves lab quality but also creates new international market opportunities,” concludes Dr. Thorsten Heinlein optimistically.