At Merck KGaA, Darmstadt, Germany, our commitment to ensuring the safety and quality of diagnostic solutions for patients and healthcare professionals is unwavering. As we transition into the full application of the European Union In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) which went into limited effect on May 26, 2022, we are dedicated to meeting the highest standards in the industry.

IVDR Compliance Journey

Our organization has been working to support these initiatives for the past several years, involving over a thousand employees globally. We continue to successfully progress with the certification of our IVD portfolios, with a focus on upholding industry-leading quality standards.

Global Support for IVD Products

Diagnostic tools such as routine and special stains, immunohistochemistry antibodies, and reagents have become essential to Anatomic Pathology laboratories over the past several decades. To ensure the accessibility of Cell Marque™ and Sigma-Aldrich® products worldwide, especially in geographies impacted by IVDR, our global program is designed to guarantee the seamless availability of IVDR compliant IVD devices, reflecting our commitment to patient care.


Who is impacted by IVDR?

IVDR is the current regulatory basis for placing on the market, making available, and putting into service, in vitro diagnostic medical devices on the European market. It not only impacts manufacturers, economic operators, healthcare professionals, and patients in the European Union, it also has a global impact. The higher level of public health protection measurements via safety, performance, and new compliance requirements set by IVDR impact our entire IVD portfolio. The pursuit of IVDR compliance demands significant investment in terms of effort and cost, along with challenging decisions as to the breadth of the portfolio and availability of all IVDs.

What is IVDR?

IVDR is the European Union In-Vitro Diagnostic Regulation (2017/746/EU), is a comprehensive regulatory framework aimed at improving clinical safety and ensuring fair market access for manufacturers and healthcare professionals. This framework classifies devices into different risk categories (A, B, C, or D) with A and D representing the lowest and highest risks, respectively. The aim of the IVDR is to lift In-Vitro-Diagnostics to an even higher level of Safety and Performance.

When will IVDR regulations be enforced?

The full application of IVDR is effective as of May 26, 2022, with a progressive rollout based on risk categories. Enforcement for class A began on May 26th, 2022; enforcement for class B, C, and D occurs on December 31 in 2029, 2028, and 2027 respectively. Devices lawfully placed on the market pursuant to Directive 98/79/EC (IVDD) before 26 May 2022 may continue to be available on the market or put into service.

How are the Tissue Diagnostics products classified under IVDR?

Our Sigma-Aldrich® and Cell Marque™ IVD products are categorized under IVDR based on the new classification system. The majority of the Cell Marque™ products will be class C under IVDR, with some class B and A as well. As for the Sigma-Aldrich® IVD products, most are class A under IVDR. This categorization ensures compliance with risk levels and regulatory requirements.

Why is IVDR being implemented in the EU?

IVDR is being implemented in the EU to align legislation with technical advances, changes in medical science, and progress in law-making, ultimately enhancing the quality and safety of IVD devices.

How will I know if a product is compliant and marketed under IVDR?

If you would like specific product information, please contact your account manager or distributor. Products Class B and higher that are certified will show a four-digit number of the Notified Body right to the “CE”-sign as part of their labeling.


Merck KGaA, Darmstadt, Germany, remains committed to supporting our customers through the IVDR transition. Our focus is on providing compliant, vital products to healthcare systems and patients, reflecting our dedication to meeting tomorrow's regulations today.

For additional information or inquiries, contact us.