In vitro diagnostic (IVD) devices are essential tools for disease detection and clinical decision-making — from rapid antigen tests and glucose monitoring strips to molecular diagnostics, immunoassay platforms, and next-generation sequencing kits. They underpin treatment decisions for millions of patients globally, which is why they are among the most stringently regulated categories of medical devices in every major market.
For manufacturers and importers operating across multiple markets, 2025 and 2026 have brought significant regulatory changes across all three of the world’s major IVD regulatory frameworks — India’s CDSCO, the EU IVDR, and the US FDA. Understanding how these frameworks compare, where they diverge, and what has changed recently is essential for any business navigating multi-market IVD compliance.
This guide gives you a comprehensive, current-as-of-2026 overview of IVD regulation across India, the EU, and the USA — covering classification, registration pathways, performance evaluation requirements, and the key 2025–2026 updates that may require immediate action.
What Are IVD Devices? — Scope and Definition
An In Vitro Diagnostic device is any medical device — reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, piece of software, or system — intended to be used for examining specimens derived from the human body, such as blood, urine, tissue samples, or swabs.
IVDs generate information about physiological or pathological states, congenital disorders, predisposition to medical conditions, safety and compatibility with other individuals, and the effect of treatment. Key categories include:
- Infectious disease diagnostics — HIV, hepatitis B/C, TB, malaria, dengue, influenza, SARS-CoV-2
- Blood group serology — blood typing, compatibility testing for transfusion
- Cancer biomarker assays — tumour markers, companion diagnostics for targeted therapies
- Metabolic and endocrine diagnostics — glucose monitoring, thyroid function, HbA1c
- Genetic and molecular diagnostics — PCR, NGS, FISH, cytogenetics
- Autoimmune and allergy diagnostics — ANA, ANCA, allergen-specific IgE
- Point-of-Care (POC) testing devices — rapid diagnostic tests for home and clinical use
Part 1: IVD Regulation in India — CDSCO Under MDR 2017
Regulatory Authority and Legal Framework
In India, IVD devices are regulated under the Medical Devices Rules (MDR), 2017, administered by the Central Drugs Standard Control Organization (CDSCO). The Central Licensing Authority (CLA) — the Drugs Controller General of India (DCGI) — is the competent authority for:
- Import of all classes of IVD medical devices
- Manufacture of Class C and Class D IVD devices
- Clinical performance evaluation and approval of new IVDs
- Co-ordination with State Licensing Authorities (SLAs)
State Licensing Authorities handle manufacturing licences for Class A and Class B IVDs.
India IVD Classification System
IVD devices are classified under Part II of the First Schedule of MDR 2017 based on risk parameters:
| Class | Risk Level | Examples | Authority |
| Class A | Low — general laboratory use | General chemistry reagents, lab instruments (non-diagnostic), culture media | SLA |
| Class B | Low-Moderate | Blood glucose meters, pregnancy tests, general diagnostic kits (non-high risk) | SLA |
| Class C | Moderate-High | Cancer screening assays, HCV kits, genetic disease testing, companion diagnostics | CLA (CDSCO) |
| Class D | High — high public health risk | HIV diagnostic kits, HBsAg kits for blood banking, blood group serology | CLA (CDSCO) |
Important 2025 update: CDSCO updated the risk-based classification list for IVDs in 2023 and continues to publish updated classification lists on its website. The October 2025 CDSCO directive to SLAs reinforced that no IVD licence can be issued for unclassified devices — CLA classification must precede licensing by SLAs. Verify your IVD’s current classification on the CDSCO SUGAM portal before any application is initiated.
India IVD Registration Pathways
For import of IVD devices, the application is submitted in Form MD-14 on the SUGAM portal (cdscoonline.gov.in), leading to the Form MD-15 Import Licence. For manufacturing, it is Form MD-7 (Class C/D) → MD-9 licence, or Form MD-4 (Class A/B) → MD-5 licence via the SLA.
The India-Specific Requirement: In-Country Performance Evaluation
This is the most significant differentiating requirement of India’s IVD framework compared to most other markets: for new IVD devices of Class B, C, and D, clinical performance evaluation in India is mandatory — regardless of international approvals held.
This means: even if your IVD holds US FDA clearance or EU IVDR CE marking, India requires India-specific performance evaluation data before your device can be licensed for import or manufacture.
What India’s performance evaluation requires:
- Evaluation conducted at CDSCO-authorised and ICMR/AIIMS-designated laboratories
- Sensitivity, specificity, and accuracy testing against CDSCO-specified acceptance criteria
- For certain disease categories (TB, dengue, malaria, influenza, HIV, HBV, HCV), ICMR and CDSCO have issued 39 standardised evaluation protocols with defined acceptance thresholds
- Minimum sample requirements and testing conditions as per protocol
ICMR-CDSCO standardised acceptance criteria (examples):
| Assay Type | Minimum Sensitivity | Minimum Specificity |
| ELISA | ≥90% | ≥95% |
| Rapid Diagnostic Test (RDT) | ≥80% | ≥90% |
| PCR assay | ≥95% | ≥98% |
| Multiplex assay | Per ICMR-CDSCO protocol | Per ICMR-CDSCO protocol |
Key 2025–2026 India IVD Regulatory Updates
- CDSCO Updated Authorised Laboratories List (January 19, 2026): CDSCO published an updated, India-wide list of authorised laboratories for IVD performance evaluation — mapping specific disease categories (HIV, HBV, HCV, TB, dengue, influenza, SARS-CoV-2) to designated government and ICMR/AIIMS facilities with nodal contacts. Manufacturers and importers must use these labs for evaluation under MDR 2017.
- Draft Guidance for IVD Import (January 2026): CDSCO released a draft guidance document for import of IVD devices for stakeholder comment (dated 30.01.2026). This guidance covers application pathways, checklists, timelines, and common non-compliances observed in IVD import applications.
- ICMR-CDSCO IVD Innovators Handbook: ICMR and CDSCO jointly released MedTech Mitra’s IVD Innovators Handbook — a structured, stage-wise roadmap covering proof of principle, classification, analytical and clinical performance evaluation, QMS implementation, and documentation with submission checklists linked to MDR 2017 forms.
- FAQ Addendum on IVDs (March 13, 2026): CDSCO published Addendum to Doc No. CDSCO.IVD.FAQ.04.2022 dated 13.03.2026 — providing further regulatory clarifications on IVD licensing.
- New Risk Classification Module (November 2025): Applicants for IVDs not yet in CDSCO’s classification list can now use the new Risk Classification Module on cdscomdonline.gov.in to submit classification requests.
Part 2: IVD Regulation in the EU — IVDR 2017/746
Regulatory Framework
The EU regulates IVD devices under Regulation (EU) 2017/746 (IVDR) — the In Vitro Diagnostic Medical Devices Regulation. It replaced the outdated IVD Directive (IVDD) 98/79/EC and became fully applicable on 26 May 2022. The IVDR introduces stricter requirements for clinical evidence, mandatory Notified Body involvement, and comprehensive data registration in EUDAMED.
EU IVD Classification Under IVDR
| Class | Risk Level | Examples | Conformity Assessment |
| Class A | Lowest risk | Laboratory equipment, general reagents, culture media | Self-declaration (unless sterile — sterile Class A requires Notified Body for sterility aspects) |
| Class B | Moderate risk | General diagnostic tests, urine analysis, general serology | Notified Body mandatory |
| Class C | High individual / moderate public health risk | Cancer screening assays, companion diagnostics, genetic testing | Notified Body mandatory + EU Reference Laboratory (EURL) |
| Class D | High individual and public health risk | HIV, HBV, HCV, blood screening products | Notified Body mandatory + EURL consultation + Common Specifications |
Major change from IVDD: Under the old IVDD, approximately 80% of IVD devices were self-certified. Under IVDR, that proportion is dramatically reversed — approximately 80% of devices now require Notified Body assessment. This is the primary reason the EU has experienced Notified Body capacity shortages and extended transition timelines.
Key IVDR Requirements
- Performance Evaluation: Mandatory for all IVDR devices — analytical performance data, clinical performance data, and scientific validity evaluation are all required. Unlike India’s framework, EU performance evaluation can use existing data if robust — new clinical investigations are not always mandatory.
- General Safety and Performance Requirements (GSPRs): Annex I of IVDR — all devices must demonstrate conformity with all applicable GSPRs.
- Technical Documentation: Comprehensive technical file required — device description, design, manufacturing, performance evaluation, risk management, labelling, and PMS/PMPF plans.
- Person Responsible for Regulatory Compliance (PRRC): All manufacturers and importers must designate a PRRC with specific technical and regulatory qualifications.
- Post-Market Performance Follow-up (PMPF): Proactive ongoing monitoring of device performance after market launch — a significant additional burden versus IVDD.
- UDI System: All IVDR devices must carry a Unique Device Identifier and be registered in EUDAMED’s UDI/Device module.
IVDR Transition Timelines (Current Status — 2026)
| IVD Class | IVDR Compliance Deadline | Status |
| Class D (highest risk) | 26 May 2025 | Deadline passed — must be IVDR compliant now |
| Class C (high individual risk) | 26 May 2026 | Deadline approaching — must have Notified Body application and agreement |
| Class B and sterile Class A | 26 May 2027 | Transition ongoing |
EUDAMED — Mandatory from 28 May 2026 (Critical Update)
This is the most significant EU IVD regulatory development of 2025–2026: EUDAMED’s first four modules become mandatory for all MDR- and IVDR-compliant devices from 28 May 2026.
Commission Decision (EU) 2025/2371 was published on 27 November 2025, confirming that four EUDAMED modules are functional — Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance. From 28 May 2026, EUDAMED is no longer optional or voluntary. If an obligation is linked to one of the four modules, it must be done in EUDAMED.
Key EUDAMED dates for IVD manufacturers:
- 28 May 2026 — Mandatory use of four modules: Actor registration, UDI/Device registration, Notified Bodies & Certificates, Market Surveillance
- 28 November 2026 — Final deadline to register legacy devices (placed on market before 28 May 2026 but still sold afterwards)
- 28 May 2027 — Notified Bodies must complete upload of legacy IVDR certificate information
For Indian IVD manufacturers exporting to the EU: Your EU Authorised Representative must register in EUDAMED’s Actor module before 28 May 2026. Your devices must be registered in the UDI/Device module. Delays in EUDAMED registration will block market access from this date.
Part 3: IVD Regulation in the USA — US FDA Framework
Regulatory Authority
In the United States, IVD devices are regulated by the US Food and Drug Administration (FDA) — specifically the Center for Devices and Radiological Health (CDRH). The governing legislation is the Federal Food, Drug, and Cosmetic Act (FD&C Act), with IVDs regulated as medical devices under 21 CFR Parts 800–899.
US FDA IVD Classification
| Class | Risk Level | Regulatory Control | Pathway |
| Class I | Low | General controls — most exempt from 510(k) | 510(k) exempt or 510(k) |
| Class II | Moderate | General + Special controls | 510(k) — substantial equivalence to predicate |
| Class III | High | General + Special + Premarket Approval | PMA — valid scientific evidence of safety and effectiveness |
Key FDA IVD Regulatory Pathways
510(k) — Premarket Notification: The most common pathway for Class II IVDs. The manufacturer demonstrates substantial equivalence to a legally marketed predicate device. FDA’s target review time is 90 days, with a realistic timeline of 3–6 months including Additional Information (AI) request cycles. Analytical performance data — sensitivity, specificity, precision, and interference — must be submitted. Clinical studies are required when analytical performance alone is insufficient.
De Novo: For novel IVDs with no predicate device that are low-to-moderate risk. FDA independently establishes special controls and classifies the device through the De Novo pathway. Typical timeline: 12+ months.
PMA — Premarket Approval: For high-risk Class III IVDs — typically companion diagnostics, HIV tests, and blood screening IVDs. Requires valid scientific evidence of safety and effectiveness from clinical studies. Most rigorous and time-consuming pathway (18–36 months). Annually requires PMA supplements for significant changes.
EUA — Emergency Use Authorization: Used during declared public health emergencies (as extensively used for COVID-19 IVDs). Not a standard commercialisation pathway.
CLIA Waiver — Critical for POC Testing
For Point-of-Care IVDs intended for use outside traditional laboratory settings — including home use, physician offices, and pharmacies — CLIA (Clinical Laboratory Improvement Amendments) waiver status is essential for wide commercial adoption in the US market. Without CLIA waiver, use is restricted to certified laboratories. CLIA waiver requires demonstrating that the test is simple to use with minimal risk of harm from incorrect results, and requires additional analytical studies demonstrating performance in non-laboratory conditions.
Key 2025–2026 FDA IVD Updates
- Laboratory Developed Tests (LDT) Final Rule: FDA finalized its rule on oversight of LDTs in 2024, phasing in requirements for laboratories that develop and use their own diagnostic tests. This significantly expands FDA’s oversight of in-house diagnostic testing in hospital and reference laboratories.
- AI/ML-Based IVD Guidance: FDA continues to develop guidance on AI/ML-enabled IVDs — the Predetermined Change Control Plan (PCCP) framework allows manufacturers to pre-specify certain device modifications without requiring new submissions.
- QMSR (Quality Management System Regulation): FDA’s updated QMSR (21 CFR Part 820) aligning with ISO 13485 takes effect in 2026 for all medical device manufacturers including IVD manufacturers — requiring QMS alignment with ISO 13485:2016.
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 of other approvals | 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 |
Multi-Market Strategy: What IVD Manufacturers Need to Consider
No Shortcuts Between Markets
The most important strategic reality for IVD manufacturers pursuing multiple markets: regulatory approvals are not transferable. US FDA 510(k) clearance does not reduce India’s performance evaluation requirement. EU IVDR CE marking does not substitute for CDSCO registration. Each market requires independent compliance — and each has its own dossier format, performance data requirements, and submission process.
Plan Performance Evaluation Studies Strategically
India’s mandatory in-country performance evaluation is the most unique requirement. For manufacturers already holding US FDA or EU IVDR approval with strong performance data, the India evaluation adds an incremental burden — but the data must be generated in India at CDSCO-authorised facilities. Plan this evaluation as early as possible in your India market entry timeline — it is typically the longest single lead-time item, running 3–9 months for Class C/D devices.
EU EUDAMED Registration Is Now Urgent
For any IVD manufacturer selling in the EU, EUDAMED Actor registration must be completed before 28 May 2026. This is not optional — failure to register means devices cannot be placed on the EU market after that date. Initiate EUDAMED registration immediately if not already done.
Class C IVDR Compliance — Immediate Priority
The 26 May 2026 compliance deadline for Class C IVDs in the EU means that by now (2026), Class C device manufacturers must have lodged a formal Notified Body application and have an agreement in place. If this has not been done, market access in the EU for Class C IVDs may be at risk.
IVD-Specific Documents Required for India Registration (Quick Reference)
- Form MD-14 application (import) or MD-7 (manufacturing Class C/D) via SUGAM portal
- IVD Master File (as per Appendix II of the Fourth Schedule, MDR 2017)
- Plant Master File (from overseas manufacturer)
- Performance Evaluation data — from CDSCO-authorised Indian laboratories
- QMS documentation — Quality Manual per Schedule V of MDR 2017
- Essential Principles checklist
- Risk analysis per ISO 14971
- Labelling compliant with MDR 2017 — including IFU
- Free Sale Certificate (for imports)
- Authorization letter from manufacturer (for imports)
- Test reports from NABL-accredited / CDSCO-notified laboratories
The Bottom Line
IVD regulation is tightening simultaneously across all three major markets in 2025–2026. India is strengthening its performance evaluation framework with standardised ICMR-CDSCO protocols and an updated authorised laboratory list. The EU is mandating EUDAMED registration from May 2026 while enforcing IVDR compliance deadlines by class. The US is expanding FDA oversight of laboratory-developed tests and implementing the updated QMSR.
For manufacturers and importers operating across these markets, the key actions are clear:
- Verify your IVD’s current classification in each market
- Begin India in-country performance evaluation planning immediately — it is the longest lead-time requirement
- Complete EU EUDAMED Actor registration before 28 May 2026
- Confirm Class C IVDR Notified Body status — deadline is 26 May 2026
- Review QMS against updated requirements (ISO 13485, QMSR, MDR 2017 Schedule V)
Need Help Navigating IVD Regulation Across India, EU, or USA?
We assist IVD manufacturers and importers with:
- India IVD classification and CDSCO registration (MD-14 → MD-15; MD-7 → MD-9)
- India in-country performance evaluation planning and lab coordination
- IVD Master File and technical dossier preparation per MDR 2017
- EU IVDR technical documentation and Notified Body submission support
- EUDAMED Actor and UDI registration (mandatory from May 2026)
- US FDA 510(k) pathway determination and submission support
- Multi-market IVD regulatory strategy
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