ABL Diagnostics secures BSI for IVDR transition

ABL Diagnostics said it has secured a partnership with BSI to move its CE-IVD portfolio through Europe’s IVDR transition, keeping products available through the regulatory deadline windows. The company also expanded GRC and R&D staff and upgraded its quality system to support future product launches in the U.S. and other global markets.

Why it matters: - The BSI engagement helps ABL Diagnostics keep its CE-IVD products on the market while Europe’s tougher IVDR rules take effect. - The transition also positions ABL Diagnostics for future regulatory work in the U.S., Asia-Pacific and Latin America. - The company’s upgraded compliance and quality systems are meant to support both existing products and new assays in development.

What happened: - ABL Diagnostics said it has formally engaged BSI, a global Notified Body, for its IVDR transition. - The announcement covers the company’s full portfolio, including wet-lab assays and software as a medical device. - The transition is being handled in coordination with ABL Luxembourg, the parent company and legal manufacturer of the CE-IVD-marked products. - ABL Diagnostics said the move is on track with the expected regulatory timelines.

The details: - Most of ABL Diagnostics’ products fall under Class C, with a transition deadline of Dec. 31, 2028. - That group includes the DeepChek® disease-genotyping assays and the ViroScore and DeepChek® software products. - The UltraGene qPCR line falls under Class B, with a transition deadline of Dec. 31, 2029. - The company said it had already completed preliminary requirements, including an upgraded Quality Management System and submissions to BSI. - The upgraded QMS is already ISO 13485 certified. - ABL Diagnostics said it expanded its Governance, Risk and Compliance team and its Research and Development team with specialized hires. - The workforce additions are intended to handle the heavier IVDR documentation, clinical evidence and post-market surveillance burden. - ABL Diagnostics said its current CE-IVD innovations will remain available through at least the end of the transition period. - The company also said it is marketing products and services from sister company CDL Pharma under an intra-group strategy agreement that began in the second half of 2025. - ABL Diagnostics’ broader product set includes real-time syndromic PCR tests, Nadis® patient medical record software used in more than 200 hospitals in France for HIV and hepatitis management, and MediaChek® clinical sample collection kits.

Between the lines: - The BSI milestone is not just a compliance step. It also reduces the risk that ABL Diagnostics’ portfolio gets caught in the bottleneck of Europe’s stricter diagnostic rules. - The company is using the same regulatory work to build a pipeline for new DeepChek® and UltraGene products. - Management is signaling that IVDR design controls will be embedded earlier in development, which could shorten the path from product design to market approval. - Anchoring the QMS to ISO 13485:2016 also suggests ABL Diagnostics wants a more portable regulatory platform across multiple regions, not only Europe.

What’s next: - ABL Diagnostics said individual products will continue receiving IVDR certificates ahead of the deadlines. - The company expects the current portfolio to stay available through the transition windows as certifications are finalized. - ABL Diagnostics will keep customers and stakeholders updated as each product moves through certification. - The company expects its upgraded regulatory framework to support future launches in global markets, including readiness for FDA QMSR requirements.