The global IVDR certification market is estimated to be valued at USD 6,324.9 Mn in 2026 and is expected to reach USD 9,870.1 Mn by 2033, exhibiting a compound annual growth rate (CAGR) of 6.6% from 2026 to 2033. IVDR certification, as required under the EU IVDR (2017/746) is the rigorous process through which in-vitro diagnostics (IVDs) meet specific EU safety, clinical evidence, analytical performance, risk management and post-market surveillance standards, prior to their entry to the market in Europe. It typically comprises the technical documentation, quality management system, and performance evaluation of an IVD, the result of which is a conformity assessment conducted by a Notified Body according to the risk class of the device.
The global IVDR certification market is experiencing significant expansion fueled by the widespread rollout of the EU IVDR, tightened regulations across all IVDs and the elevated demand for certified companion diagnostics, molecular and point-of-care diagnostic applications. As regulatory affairs consultancies and Notified Bodies rise in importance and investment in compliance services and technical documentation services increases, there has been accelerated adoption of IVDR certification among existing and emerging IVD developers.
Market Dynamics
The global IVDR certification market is driven by stringent implementation of the European Union In Vitro Diagnostic Regulation (EU IVDR) that necessitates in vitro diagnostic device makers have clinical evidence, a performance evaluation, and a post-market surveillance program in place to meet new requirements. Increasing in vitro diagnostic devices needing a conformity assessment, along with the rise in regulatory and certification activities, have resulted in an upswing in outsourcing.
However, the growth of the IVDR certification market is limited by factors such as limited availability of IVDR-designated Notified Bodies, lengthy certification timelines, and the high cost of compliance, particularly for small and medium-sized manufacturers. Nevertheless, enhancements to digital regulatory management tools, increasing investments in regulatory consulting services, and the expansion of Notified Body capacity will offer new opportunities for growth in IVDR certification market.
Key Features of the Study
• This report provides in-depth analysis of the global IVDR certification market, and provides market size (USD Million) and compound annual growth rate (CAGR%) for the forecast period (2026–2033), considering 2025 as the base year
• It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
• This study also provides key insights about market drivers, restraints, opportunities, new product launches or approvals, market trends, regional outlook, and competitive strategies adopted by key players
• It profiles key players in the global IVDR certification market based on the following parameters – company highlights, products portfolio, key highlights, financial performance, and strategies
• Key companies covered as a part of this study include TÜV SÜD AG, TÜV Rheinland AG, DEKRA SE, BSI Group, SGS SA, Intertek Group plc, UL Solutions Inc., DNV Group AS, Kiwa N.V., and Eurofins Scientific SE
• Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
• The global IVDR certification market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
• Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global IVDR certification market
Market Segmentation
• Device Type Insights (Revenue, USD Mn, 2021 - 2033)
o Laboratory-based
o Point-of-Care
• Regulatory Class Insights (Revenue, USD Mn, 2021 - 2033)
o Class I
o Class II
o Class III
o Class IV
• Sourcing Type Insights (Revenue, USD Mn, 2021 - 2033)
o In-house
o Outsource
• End User Insights (Revenue, USD Mn, 2021 - 2033)
o Medical Device Companies
o Hospitals and Clinics
o Diagnostic Laboratories / Centers
o CDMO and CMO
o Others
• Regional Insights (Revenue, USD Mn, 2021 - 2033)
o North America
U.S.
Canada
o Latin America
Brazil
Argentina
Mexico
Rest of Latin America
o Europe
Germany
U.K.
Spain
France
Italy
Russia
Rest of Europe
o Asia Pacific
China
India
Japan
Australia
South Korea
ASEAN
Rest of Asia Pacific
o Middle East
GCC Countries
Israel
Rest of Middle East
o Africa
South Africa
North Africa
Central Africa
• Key Players Insights
o TÜV SÜD AG
o TÜV Rheinland AG
o DEKRA SE
o BSI Group
o SGS SA
o Intertek Group plc
o UL Solutions Inc.
o DNV Group AS
o Kiwa N.V.
o Eurofins Scientific SE
目錄 Table of Contents
Table of Contents
1. Research Objectives and Assumptions
o Research Objectives
o Assumptions
o Abbreviations
2. Market Purview
o Report Description
Market Definition and Scope
o Executive Summary
Global IVDR Certification Market, By Device Type
Global IVDR Certification Market, By Regulatory Class
Global IVDR Certification Market, By Sourcing Type
Global IVDR Certification Market, By End User
Global IVDR Certification Market, By Region
3. Market Dynamics, Regulations, and Trends Analysis
o Market Dynamics
o Impact Analysis
o Key Highlights
o Regulatory Scenario
o Product Launches/Approvals
o PEST Analysis
o PORTER’s Analysis
o Market Opportunities
o Regulatory Scenario
o Industry Trends
4. Global IVDR Certification Market, By Device Type, 2021-2033, (USD Mn)
o Introduction
Market Share Analysis, 2026 and 2033 (%)
Y-o-Y Growth Analysis, 2022 - 2033
Segment Trends
o Laboratory-based
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
o Point-of-Care
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
5. Global IVDR Certification Market, By Regulatory Class, 2021-2033, (USD Mn)
o Introduction
Market Share Analysis, 2026 and 2033 (%)
Y-o-Y Growth Analysis, 2022 - 2033
Segment Trends
o Class I
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
o Class II
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
o Class III
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
o Class IV
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
6. Global IVDR Certification Market, By Sourcing Type, 2021-2033, (USD Mn)
o Introduction
Market Share Analysis, 2026 and 2033 (%)
Y-o-Y Growth Analysis, 2022 - 2033
Segment Trends
o In-house
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
o Outsource
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
7. Global IVDR Certification Market, By End User, 2021-2033, (USD Mn)
o Introduction
Market Share Analysis, 2026 and 2033 (%)
Y-o-Y Growth Analysis, 2022 - 2033
Segment Trends
o Medical Device Companies
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
o Hospitals and Clinics
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
o Diagnostic Laboratories / Centers
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
o CDMO and CMO
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
o Others
Introduction
Market Size and Forecast, and Y-o-Y Growth, 2021-2033, (USD Mn)
8. Global IVDR Certification Market, By Region, 2021 - 2033, Value (USD Mn)
o Introduction
Market Share (%) Analysis, 2026, 2029 & 2033, Value (USD Mn)
Market Y-o-Y Growth Analysis (%), 2022 - 2033, Value (USD Mn)
Regional Trends
o North America
Introduction
Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
o U.S.
o Canada
o Latin America
Introduction
Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
o Brazil
o Argentina
o Mexico
o Rest of Latin America
o Europe
Introduction
Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
o Germany
o U.K.
o Spain
o France
o Italy
o Russia
o Rest of Europe
o Asia Pacific
Introduction
Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
o China
o India
o Japan
o Australia
o South Korea
o ASEAN
o Rest of Asia Pacific
o Middle East
Introduction
Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Country, 2021 - 2033, Value (USD Mn)
o GCC Countries
o Israel
o Rest of Middle East
o Africa
Introduction
Market Size and Forecast, By Device Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Regulatory Class, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Sourcing Type, 2021 - 2033, Value (USD Mn)
Market Size and Forecast, By End User,2021 - 2033, Value (USD Mn)
Market Size and Forecast, By Country/Region, 2021 - 2033, Value (USD Mn)
o South Africa
o North Africa
o Central Africa
9. Competitive Landscape
o TÜV SÜD AG
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
o TÜV Rheinland AG
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
o DEKRA SE
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
o BSI Group
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
o SGS SA
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
o Intertek Group plc
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
o UL Solutions Inc.
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
o DNV Group AS
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
o Kiwa N.V.
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
o Eurofins Scientific SE
Company Highlights
Product Portfolio
Key Developments
Financial Performance
Strategies
10. Analyst Recommendations
o Wheel of Fortune
o Analyst View
o Coherent Opportunity Map
11. References and Research Methodology
o References
o Research Methodology
o About us
*Browse 32 market data tables and 28 figures on ‘IVDR Certification Market' - Global forecast to 2033
量子訊息有限公司為 Coherent Market Insights 在台灣的授權代理，提供報告購買、樣本申請與授權諮詢。電話 +886 2 7751 5192 ・ 聯絡我們