IndustriesIVD
IN VITRO DIAGNOSTICS
IVD Regulatory &
Market Access Support
Build the Right Evidence. Navigate the Right Pathway.
Regulatory Strategy
Clear pathways for global market access.
Scientific Rigor
Evidence that demonstrates safety and performance.
Lifecycle Compliance
Readiness that goes beyond approval.
IVD market access requires alignment across regulatory strategy, product classification, performance
evidence, quality systems and post-market requirements.
NKB Regovanta supports IVD manufacturers across the product lifecycle—from regulatory pathway
assessment and performance evaluation to technical documentation, submission readiness and
post-market compliance.
OUR IVD EXPERTISE
REGULATORY
STRATEGY
- Regulatory pathway strategy
- Product classification
- EU IVDR strategy
- US FDA pathway assessment
PERFORMANCE &
EVIDENCE
- Performance evaluation strategy
- Scientific validity
- Analytical performance
- Clinical performance
QUALITY &
TECHNICAL
- Technical documentation
- ISO 13485 QMS support
- Risk management
- Labeling & intended purpose
MARKET &
LIFECYCLE
- Notified Body readiness
- EUDAMED & UDI
- Post-Market Performance Follow-up
- Vigilance & lifecycle compliance
Global Target Markets
Three-Market Comparison: India vs EU vs USA
| Dimension | India (CDSCO) | EU (IVDR) | USA (FDA) |
|---|---|---|---|
| Governing regulation | MDR 2017 | IVDR 2017/746 | FD&C Act / 21 CFR |
| Classification basis | Risk-based (Part II, First Schedule) | Risk + public health impact (IVDR Annex VIII) | Risk-based (I, II, III) |
| Pre-market review | CDSCO dossier review + performance evaluation | Notified Body conformity assessment (Class B/C/D) | 510(k) / De Novo / PMA |
| In-country performance data | Mandatory for Class B-D — India-specific data required | Performance evaluation mandatory — existing data may be used if robust | Analytical + clinical performance — predicate-based for 510(k) |
| Third party review | CDSCO directly (no Notified Body equivalent) | Notified Body (NB) — mandatory for Class B/C/D | FDA (no Notified Body equivalent) |
| Mutual recognition | No — India-specific performance evaluation mandatory | No — IVDR compliance required regardless of FDA/other approvals | No — FDA clearance required regardless of CE/other |
| Database registration | SUGAM portal | EUDAMED — mandatory from 28 May 2026 | FDA GUDID (Global UDI Database) |
| UDI requirement | Rule 46 MDR 2017 — pending implementation date | Mandatory under IVDR — in EUDAMED from May 2026 | Mandatory — all classes phased since 2013 |
| Post-market surveillance | MDR 2017 PMS requirements — developing | Mandatory PMPF + vigilance reporting in EUDAMED | MDR reporting, PMS studies, MedWatch |
FROM PRODUCT CONCEPT TO MARKET ACCESS
01
ASSESS
- Classification
- Intended Purpose
- Regulatory Pathway
02
BUILD
- Performance Evidence
- QMS & Risk Management
- Technical Documentation
03
SUBMIT
- Submission Strategy
- Notified Body / FDA Readiness
- Review & Response Support
04
MAINTAIN
- PMS & PMPF
- Vigilance
- Lifecycle Compliance
One regulatory strategy. One connected pathway.
TALK TO OUR IVD EXPERTSWHY LEADING IVD COMPANIES
PARTNER WITH NKB REGOVANTA
- Deep expertise in EU IVDR, US FDA and global regulatory pathways
- Strong scientific and clinical evaluation capabilities
- Integrated approach across quality, regulatory and market access
- Commitment to compliance, quality and patient safety
- Agile, responsive and globally aligned
READY TO ACCELERATE
YOUR IVD JOURNEY?
Regulatory clarity. Scientific confidence.
Global access.