Boditech Med Completes CE-IVDR Certification for 14 Diagnostic Devices and 142 Diagnostic Kits

- CE-IVDR certification process successfully completed for products sold across Europe.

- Products verified to meet increasingly stringent global certification standards.

- Additional certifications for molecular diagnostics and drug testing products underway.

Boditech Med, a leader in point-of-care diagnostics, announced on November 3rd that it has successfully completed CE-IVDR (In Vitro Diagnostic Regulation) certification for 14 diagnostic devices and 142 diagnostic kits.

The CE-IVDR is a regulation that has been mandatory for all member states of the European Union (EU) since May 2022. Diagnostic devices and kits sold in Europe are required to comply with this certification.

Boditech Med initiated the CE-IVDR certification process in November 2023 with 22 diagnostic kits and completed approvals for all its products sold in Europe through two additional phases this year. The 14 certified diagnostic devices include seven models under the ichroma brand and four under the AFIAS brand. The certified diagnostic kits cover a broad range of categories: 47 hormone-related products, 25 infectious disease products, 20 cancer-related products, 9 cardiovascular products, and 20 therapeutic drug monitoring products.

The CE-IVDR applies not only to the 27 EU member states but also to four European Free Trade Association (EFTA) countries—Iceland, Liechtenstein, Norway, and Switzerland—as well as Northern Ireland and Turkey. Moreover, global certification standards for diagnostic products have become increasingly stringent following the COVID-19 pandemic. Many countries, including Australia, Canada, Japan, Singapore, and Vietnam, have either introduced or are preparing to implement certification systems similar to the CE-IVDR.

Eui-yeol Choi, CEO of Boditech Med, commented, “The proportion of revenue from Europe has increased from less than 10% in 2019 to over 20% for three consecutive years, marking the highest share among our regional markets. During the same period, our sales in Europe have grown more than fourfold. We are currently active in 34 European countries, with rapid sales growth in Southern Europe, particularly Italy, alongside strong performance in Western Europe, including Switzerland, Germany, and France.”

He added, “In line with this growth, we have completed the certification process for all products sold in Europe, including therapeutic drug monitoring products expected to drive future revenue. Additionally, we are preparing to secure approvals for molecular diagnostics and DOA (Drugs of Abuse) products.”