Webinar - EU IVDR Class C certification for Indian manufacturers

A joint DNV - ADMI technical webinar focused on IVDR Class C documentation and submission expectations

The European Union’s In Vitro Diagnostic Regulation (IVDR) has redefined the global expectations for quality, safety, and performance in the IVD sector, particularly for Class C devices, which now fall under some of the most rigorous regulatory scrutiny. As Indian manufacturers increasingly expand toward the EU market, understanding and meeting these enhanced requirements has become essential for ensuring uninterrupted market access, long-term compliance, and global competitiveness.

In this context, DNV, in collaboration with ADMI, is hosting a focused webinar designed to guide Indian IVD manufacturers through the critical components of Class C IVDR compliance. This session will provide clarity on regulatory expectations, technical documentation requirements, conformity assessment pathways, and the DNV conformity assessment process, including audits, assessments, and ongoing surveillance activities.

Participants will gain practical insights from IVDR assessors and technical experts from DNV. The webinar will also highlight common challenges observed during assessments, along with considerations for preparing high‑quality submissions. With IVDR transition milestones approaching, this session serves as a timely opportunity for manufacturers to strengthen their readiness and align with EU regulatory expectations.

We invite stakeholders including manufacturers, quality leaders, regulatory professionals, and decision‑makers to join this session focused on supporting India’s pathway to Class C IVDR compliance.