IVDR CE Marking and the Challenges Faced by Indian IVD Manufacturers

PNN

New Delhi [India], October 24: Indian IVD manufacturers face growing regulatory hurdles under the EU IVDR. I3CGLOBAL provides strategic CE Marking support to small, medium, and large-scale manufacturers in India to access the European market faster.

With the enforcement of the EU IVDR Regulation 2017/746, Indian in vitro diagnostic (IVD) device manufacturers are facing significant challenges in achieving CE Marking certification for exports to the European market. Unlike the earlier IVDD, the IVDR demands extensive performance evaluation, post-market surveillance, and technical documentation aligned with stringent EU standards.

The new regulation reclassifies most IVD devices into higher risk categories, requiring Notified Body involvement and deeper technical scrutiny. For many Indian manufacturers, this transition has revealed critical gaps in clinical performance studies, analytical validation, biological safety, and traceability systems. Additionally, the limited number of Notified Bodies accredited under IVDR has created bottlenecks and extended review timelines.

IVDR Transition Timeline

Under the new amendments, the transitional timelines depend on the device's risk class and its certification status under the IVDD:

- Class D devices: May remain on the market until December 31, 2027, if IVDR QMS compliance and Notified Body agreements are in place by 2025.

- Class C devices: Deadline extended until December 31, 2028.

- Class B and Class A (sterile) devices: May continue until December 31, 2029.

- Class A (non-sterile) devices: No transition period; full IVDR compliance is required for new market entries.

Notably, the 'sell-off' provision has been removed, allowing devices already placed on the market to remain available until the end of their shelf life or certificate expiry.

These changes provide much-needed relief to manufacturers, especially in India, where many IVD companies are still aligning their technical documentation, performance evaluation, and quality management systems with IVDR requirements.

I3CGLOBAL's Role in Supporting Indian IVD Manufacturers

I3CGLOBAL, a regulatory consulting leader with over two decades of global experience, is helping Indian IVD companies navigate these regulatory complexities. The company offers end-to-end IVDR CE Marking consultancy, including gap assessment, technical documentation preparation, performance evaluation, clinical evidence generation, and Notified Body coordination.

With a strong technical team comprising biomedical engineers, regulatory strategists, and clinical experts, and an MOU with IQZYME MEDTECH and REGHELPS SRC (Clinical CRO) for performance evaluation, we ensure that every documentation set is compliant, audit-ready, and optimised for cost and time efficiency.

"The IVDR has completely transformed how IVDs are regulated in Europe," said Soio George, Medical Device Expert at I3CGLOBAL. "Indian manufacturers need expert guidance to understand classification, data requirements, and regulatory strategy early in the process. Our goal is to bridge this gap and accelerate market entry for compliant, high-quality IVD products."

I3CGLOBAL continues to expand its IVDR consultancy services in all states and major cities in India and the Middle East enabling manufacturers to achieve CE certification with confidence and compliance.

About I3CGLOBAL

I3CGLOBAL is a leading regulatory consulting organisation providing CE Marking, FDA 510(k), GMP, and WHO PQ consulting for Medical Devices and In Vitro Diagnostic devices. With operations in India, the UK, Germany, and the USA, I3CGLOBAL has successfully completed more than 400 CE Mark approvals and 120+ FDA 510(k) clearances worldwide.

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