Sertio Oy Chairman & CEO Mikko Soikkeli Visits Macro & Micro-Test to Strengthen IVDR Collaboration and Present New Certificates

Suzhou, China – Mikko Soikkeli, Chairman and CEO of Sertio Oy, recently visited Macro & Micro-Test. During the visit, the two parties held in-depth discussions on IVDR product review processes, practical compliance challenges, and future cooperation. At the meeting, Mr. Soikkeli officially presented Macro & Micro-Test with three new IVDR certificates.

In-Depth Dialogue on Efficient IVDR Compliance Pathways

With the continued implementation of the EU In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746), the regulatory landscape for in vitro diagnostic products entering the European market has entered a new era. Compared with the previous IVDD framework, IVDR introduces more stringent requirements for device classification, performance evaluation, clinical evidence, and post-market surveillance.

As a Notified Body (No. 3018) designated under the EU IVDR and part of the Kiwa group, Sertio Oy provides conformity assessment and certification services for in vitro diagnostic medical devices across applicable IVDR device classes. Its expertise in IVDR conformity assessment has supported Macro & Micro-Test throughout its ongoing regulatory certification journey.

During the visit, Mr. Soikkeli and the Macro & Micro-Test team engaged in in-depth discussions on the IVDR regulatory framework and certification process. The exchange focused on key IVDR requirements, including the risk-based classification system, enhanced performance evaluation and clinical evidence requirements, as well as strengthened post-market obligations.

The two sides also shared practical insights into technical documentation, performance evaluation, and quality management system audits, while exploring ways to further optimize collaboration and communication throughout the certification process.

Mr. Soikkeli spoke highly of the professionalism and execution capabilities demonstrated by the Macro & Micro-Test team throughout their cooperation. He noted that the company’s rigorous and well-structured approach to IVDR reviews reflects its strong understanding of international regulatory requirements and thorough preparation for global market access.

New Certificates Expand Macro & Micro-Test’s IVDR-Certified Portfolio

At the meeting, Mr. Soikkeli officially presented Macro & Micro-Test with three new IVDR certificates.

The new certifications further expand Macro & Micro-Test’s IVDR-certified product portfolio and represent another important step in the company’s continued progress in the European market.

Prior to this, Macro & Micro-Test had already obtained IVDR certification for multiple detection kits and instruments. The latest certifications further strengthen the company’s IVDR-compliant portfolio and provide additional support for the international commercialization of its diagnostic solutions.

As a research-driven in vitro diagnostics company, Macro & Micro-Test has established technology platforms spanning molecular diagnostics, immunology, POCT for Infectious Control, Reproductive Health, Pharmacogenomics, Oncology and Genomic Diseases.

Through continued investment in research, product development, quality management, and regulatory compliance, Macro & Micro-Test is steadily strengthening its capabilities and presence in international markets.

A Continued Partnership for IVDR Readiness

The transition from IVDD to IVDR represents a significant regulatory transformation for the global IVD industry. Higher expectations for performance evidence, technical documentation, quality systems, and post-market surveillance require manufacturers to establish increasingly comprehensive compliance capabilities.

Macro & Micro-Test began its cooperation with Sertio Oy during the early stages of its IVDR certification planning. The recent visit by Mr. Soikkeli and the presentation of the new certificates mark another milestone in the continued development of this cooperation.

Looking ahead, Macro & Micro-Test will continue to strengthen its regulatory and quality capabilities across the product lifecycle—from research and development to post-market surveillance—and advance IVDR certification for additional products as planned.

By continuously strengthening its international compliance system and expanding its globally recognized product portfolio, Macro & Micro-Test is accelerating its international development and enhancing its ability to deliver high-quality and reliable IVD solutions to customers worldwide.

Macro & Micro-Test remains committed to advancing innovation, quality, and regulatory excellence, bringing more accessible and reliable diagnostic technologies to global markets and contributing to the continued development of the in vitro diagnostics industry.