Medical Device Regulation (MDR) certification services refer to services that evaluate and certify medical device products according to the European Union's Medical Device Regulation. MDR certification is one of the legal requirements for medical devices sold on the European market. It aims to ensure that the safety and performance of medical devices comply with the standards and regulatory requirements of the European market. EU MDR 2017/745 comes into force in May 2021 . All medical devices certified under the previous Medical Devices Directive (MDD) must be certified in accordance with the new requirements to ensure they can continue to be marketed in Europe.The EU MDR 2017/745 came into effect in May 2021. All medical devices certified under the previous Medical Device Directive (MDD) must certify to the new requirements to ensure that they can continue to be sold in the European market.
The global Medical Device Regulation (MDR) Certification Service market size is projected to grow from US$ million in 2024 to US$ million in 2030; it is expected to grow at a CAGR of %from 2024 to 2030.
The 鈥淢edical Device Regulation (MDR) Certification Service Industry Forecast鈥� looks at past sales and reviews total world Medical Device Regulation (MDR) Certification Service sales in 2022, providing a comprehensive analysis by region and market sector of projected Medical Device Regulation (MDR) Certification Service sales for 2023 through 2029. With Medical Device Regulation (MDR) Certification Service sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Medical Device Regulation (MDR) Certification Service industry.
This Insight Report provides a comprehensive analysis of the global Medical Device Regulation (MDR) Certification Service landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on Medical Device Regulation (MDR) Certification Service portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms鈥� unique position in an accelerating global Medical Device Regulation (MDR) Certification Service market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Medical Device Regulation (MDR) Certification Service and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Medical Device Regulation (MDR) Certification Service.
United States market for Medical Device Regulation (MDR) Certification Service is estimated to increase from US$ million in 2023 to US$ million by 2030, at a CAGR of % from 2024 through 2030.
China market for Medical Device Regulation (MDR) Certification Service is estimated to increase from US$ million in 2023 to US$ million by 2030, at a CAGR of % from 2024 through 2030.
Europe market for Medical Device Regulation (MDR) Certification Service is estimated to increase from US$ million in 2023 to US$ million by 2030, at a CAGR of % from 2024 through 2030.
Global key Medical Device Regulation (MDR) Certification Service players cover T脺V Rheinland, DQS, Intertek, DEKRA, SGS Soci茅t茅 G茅n茅rale de Surveillance SA, etc. In terms of revenue, the global two largest companies occupied for a share nearly % in 2023.
This report presents a comprehensive overview, market shares, and growth opportunities of Medical Device Regulation (MDR) Certification Service market by product type, application, key players and key regions and countries.
Segmentation by Type:
Assessment and Certification Services
Training銆丄ssessment and Certification Services
Others
Segmentation by Application:
Manufacturers of Medical Devices
Authorized Representatives of Medical Devices
Importers and Distributors of Medical Devices
Research and Development Organizations and Medical Innovation Companies
Others
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
Segmentation by Type:
Assessment and Certification Services
Training銆丄ssessment and Certification Services
Others
Segmentation by Application:
Manufacturers of Medical Devices
Authorized Representatives of Medical Devices
Importers and Distributors of Medical Devices
Research and Development Organizations and Medical Innovation Companies
Others
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
T脺V Rheinland
DQS
Intertek
DEKRA
SGS Soci茅t茅 G茅n茅rale de Surveillance SA
RISE
BSI
DNV MEDCERT GmbH
Eurofins
ITC ZL脥N
3EC International
CE Certiso
Certiquality
IMQ
Kiwa
Please Note - This is an on demand report and will be delivered in 2 business days (48 hours) post payment.
1 Scope of the Report
1.1 Market Introduction
1.2 Years Considered
1.3 Research Objectives
1.4 Market Research Methodology
1.5 Research Process and Data Source
1.6 Economic Indicators
1.7 Currency Considered
1.8 Market Estimation Caveats
2 Executive Summary
2.1 World Market Overview
2.1.1 Global Medical Device Regulation (MDR) Certification Service Market Size 2019-2030
2.1.2 Medical Device Regulation (MDR) Certification Service Market Size CAGR by Region (2019 VS 2023 VS 2030)
2.1.3 World Current & Future Analysis for Medical Device Regulation (MDR) Certification Service by Country/Region, 2019, 2023 & 2030
2.2 Medical Device Regulation (MDR) Certification Service Segment by Type
2.2.1 Assessment and Certification Services
2.2.2 Training銆丄ssessment and Certification Services
2.2.3 Others
2.3 Medical Device Regulation (MDR) Certification Service Market Size by Type
2.3.1 Medical Device Regulation (MDR) Certification Service Market Size CAGR by Type (2019 VS 2023 VS 2030)
2.3.2 Global Medical Device Regulation (MDR) Certification Service Market Size Market Share by Type (2019-2024)
2.4 Medical Device Regulation (MDR) Certification Service Segment by Application
2.4.1 Manufacturers of Medical Devices
2.4.2 Authorized Representatives of Medical Devices
2.4.3 Importers and Distributors of Medical Devices
2.4.4 Research and Development Organizations and Medical Innovation Companies
2.4.5 Others
2.5 Medical Device Regulation (MDR) Certification Service Market Size by Application
2.5.1 Medical Device Regulation (MDR) Certification Service Market Size CAGR by Application (2019 VS 2023 VS 2030)
2.5.2 Global Medical Device Regulation (MDR) Certification Service Market Size Market Share by Application (2019-2024)
3 Medical Device Regulation (MDR) Certification Service Market Size by Player
3.1 Medical Device Regulation (MDR) Certification Service Market Size Market Share by Player
3.1.1 Global Medical Device Regulation (MDR) Certification Service Revenue by Player (2019-2024)
3.1.2 Global Medical Device Regulation (MDR) Certification Service Revenue Market Share by Player (2019-2024)
3.2 Global Medical Device Regulation (MDR) Certification Service Key Players Head office and Products Offered
3.3 Market Concentration Rate Analysis
3.3.1 Competition Landscape Analysis
3.3.2 Concentration Ratio (CR3, CR5 and CR10) & (2022-2024)
3.4 New Products and Potential Entrants
3.5 Mergers & Acquisitions, Expansion
4 Medical Device Regulation (MDR) Certification Service by Region
4.1 Medical Device Regulation (MDR) Certification Service Market Size by Region (2019-2024)
4.2 Global Medical Device Regulation (MDR) Certification Service Annual Revenue by Country/Region (2019-2024)
4.3 Americas Medical Device Regulation (MDR) Certification Service Market Size Growth (2019-2024)
4.4 APAC Medical Device Regulation (MDR) Certification Service Market Size Growth (2019-2024)
4.5 Europe Medical Device Regulation (MDR) Certification Service Market Size Growth (2019-2024)
4.6 Middle East & Africa Medical Device Regulation (MDR) Certification Service Market Size Growth (2019-2024)
5 Americas
5.1 Americas Medical Device Regulation (MDR) Certification Service Market Size by Country (2019-2024)
5.2 Americas Medical Device Regulation (MDR) Certification Service Market Size by Type (2019-2024)
5.3 Americas Medical Device Regulation (MDR) Certification Service Market Size by Application (2019-2024)
5.4 United States
5.5 Canada
5.6 Mexico
5.7 Brazil
6 APAC
6.1 APAC Medical Device Regulation (MDR) Certification Service Market Size by Region (2019-2024)
6.2 APAC Medical Device Regulation (MDR) Certification Service Market Size by Type (2019-2024)
6.3 APAC Medical Device Regulation (MDR) Certification Service Market Size by Application (2019-2024)
6.4 China
6.5 Japan
6.6 South Korea
6.7 Southeast Asia
6.8 India
6.9 Australia
7 Europe
7.1 Europe Medical Device Regulation (MDR) Certification Service Market Size by Country (2019-2024)
7.2 Europe Medical Device Regulation (MDR) Certification Service Market Size by Type (2019-2024)
7.3 Europe Medical Device Regulation (MDR) Certification Service Market Size by Application (2019-2024)
7.4 Germany
7.5 France
7.6 UK
7.7 Italy
7.8 Russia
8 Middle East & Africa
8.1 Middle East & Africa Medical Device Regulation (MDR) Certification Service by Region (2019-2024)
8.2 Middle East & Africa Medical Device Regulation (MDR) Certification Service Market Size by Type (2019-2024)
8.3 Middle East & Africa Medical Device Regulation (MDR) Certification Service Market Size by Application (2019-2024)
8.4 Egypt
8.5 South Africa
8.6 Israel
8.7 Turkey
8.8 GCC Countries
9 Market Drivers, Challenges and Trends
9.1 Market Drivers & Growth Opportunities
9.2 Market Challenges & Risks
9.3 Industry Trends
10 Global Medical Device Regulation (MDR) Certification Service Market Forecast
10.1 Global Medical Device Regulation (MDR) Certification Service Forecast by Region (2025-2030)
10.1.1 Global Medical Device Regulation (MDR) Certification Service Forecast by Region (2025-2030)
10.1.2 Americas Medical Device Regulation (MDR) Certification Service Forecast
10.1.3 APAC Medical Device Regulation (MDR) Certification Service Forecast
10.1.4 Europe Medical Device Regulation (MDR) Certification Service Forecast
10.1.5 Middle East & Africa Medical Device Regulation (MDR) Certification Service Forecast
10.2 Americas Medical Device Regulation (MDR) Certification Service Forecast by Country (2025-2030)
10.2.1 United States Market Medical Device Regulation (MDR) Certification Service Forecast
10.2.2 Canada Market Medical Device Regulation (MDR) Certification Service Forecast
10.2.3 Mexico Market Medical Device Regulation (MDR) Certification Service Forecast
10.2.4 Brazil Market Medical Device Regulation (MDR) Certification Service Forecast
10.3 APAC Medical Device Regulation (MDR) Certification Service Forecast by Region (2025-2030)
10.3.1 China Medical Device Regulation (MDR) Certification Service Market Forecast
10.3.2 Japan Market Medical Device Regulation (MDR) Certification Service Forecast
10.3.3 Korea Market Medical Device Regulation (MDR) Certification Service Forecast
10.3.4 Southeast Asia Market Medical Device Regulation (MDR) Certification Service Forecast
10.3.5 India Market Medical Device Regulation (MDR) Certification Service Forecast
10.3.6 Australia Market Medical Device Regulation (MDR) Certification Service Forecast
10.4 Europe Medical Device Regulation (MDR) Certification Service Forecast by Country (2025-2030)
10.4.1 Germany Market Medical Device Regulation (MDR) Certification Service Forecast
10.4.2 France Market Medical Device Regulation (MDR) Certification Service Forecast
10.4.3 UK Market Medical Device Regulation (MDR) Certification Service Forecast
10.4.4 Italy Market Medical Device Regulation (MDR) Certification Service Forecast
10.4.5 Russia Market Medical Device Regulation (MDR) Certification Service Forecast
10.5 Middle East & Africa Medical Device Regulation (MDR) Certification Service Forecast by Region (2025-2030)
10.5.1 Egypt Market Medical Device Regulation (MDR) Certification Service Forecast
10.5.2 South Africa Market Medical Device Regulation (MDR) Certification Service Forecast
10.5.3 Israel Market Medical Device Regulation (MDR) Certification Service Forecast
10.5.4 Turkey Market Medical Device Regulation (MDR) Certification Service Forecast
10.6 Global Medical Device Regulation (MDR) Certification Service Forecast by Type (2025-2030)
10.7 Global Medical Device Regulation (MDR) Certification Service Forecast by Application (2025-2030)
10.7.1 GCC Countries Market Medical Device Regulation (MDR) Certification Service Forecast
11 Key Players Analysis
11.1 T脺V Rheinland
11.1.1 T脺V Rheinland Company Information
11.1.2 T脺V Rheinland Medical Device Regulation (MDR) Certification Service Product Offered
11.1.3 T脺V Rheinland Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.1.4 T脺V Rheinland Main Business Overview
11.1.5 T脺V Rheinland Latest Developments
11.2 DQS
11.2.1 DQS Company Information
11.2.2 DQS Medical Device Regulation (MDR) Certification Service Product Offered
11.2.3 DQS Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.2.4 DQS Main Business Overview
11.2.5 DQS Latest Developments
11.3 Intertek
11.3.1 Intertek Company Information
11.3.2 Intertek Medical Device Regulation (MDR) Certification Service Product Offered
11.3.3 Intertek Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.3.4 Intertek Main Business Overview
11.3.5 Intertek Latest Developments
11.4 DEKRA
11.4.1 DEKRA Company Information
11.4.2 DEKRA Medical Device Regulation (MDR) Certification Service Product Offered
11.4.3 DEKRA Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.4.4 DEKRA Main Business Overview
11.4.5 DEKRA Latest Developments
11.5 SGS Soci茅t茅 G茅n茅rale de Surveillance SA
11.5.1 SGS Soci茅t茅 G茅n茅rale de Surveillance SA Company Information
11.5.2 SGS Soci茅t茅 G茅n茅rale de Surveillance SA Medical Device Regulation (MDR) Certification Service Product Offered
11.5.3 SGS Soci茅t茅 G茅n茅rale de Surveillance SA Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.5.4 SGS Soci茅t茅 G茅n茅rale de Surveillance SA Main Business Overview
11.5.5 SGS Soci茅t茅 G茅n茅rale de Surveillance SA Latest Developments
11.6 RISE
11.6.1 RISE Company Information
11.6.2 RISE Medical Device Regulation (MDR) Certification Service Product Offered
11.6.3 RISE Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.6.4 RISE Main Business Overview
11.6.5 RISE Latest Developments
11.7 BSI
11.7.1 BSI Company Information
11.7.2 BSI Medical Device Regulation (MDR) Certification Service Product Offered
11.7.3 BSI Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.7.4 BSI Main Business Overview
11.7.5 BSI Latest Developments
11.8 DNV MEDCERT GmbH
11.8.1 DNV MEDCERT GmbH Company Information
11.8.2 DNV MEDCERT GmbH Medical Device Regulation (MDR) Certification Service Product Offered
11.8.3 DNV MEDCERT GmbH Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.8.4 DNV MEDCERT GmbH Main Business Overview
11.8.5 DNV MEDCERT GmbH Latest Developments
11.9 Eurofins
11.9.1 Eurofins Company Information
11.9.2 Eurofins Medical Device Regulation (MDR) Certification Service Product Offered
11.9.3 Eurofins Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.9.4 Eurofins Main Business Overview
11.9.5 Eurofins Latest Developments
11.10 ITC ZL脥N
11.10.1 ITC ZL脥N Company Information
11.10.2 ITC ZL脥N Medical Device Regulation (MDR) Certification Service Product Offered
11.10.3 ITC ZL脥N Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.10.4 ITC ZL脥N Main Business Overview
11.10.5 ITC ZL脥N Latest Developments
11.11 3EC International
11.11.1 3EC International Company Information
11.11.2 3EC International Medical Device Regulation (MDR) Certification Service Product Offered
11.11.3 3EC International Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.11.4 3EC International Main Business Overview
11.11.5 3EC International Latest Developments
11.12 CE Certiso
11.12.1 CE Certiso Company Information
11.12.2 CE Certiso Medical Device Regulation (MDR) Certification Service Product Offered
11.12.3 CE Certiso Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.12.4 CE Certiso Main Business Overview
11.12.5 CE Certiso Latest Developments
11.13 Certiquality
11.13.1 Certiquality Company Information
11.13.2 Certiquality Medical Device Regulation (MDR) Certification Service Product Offered
11.13.3 Certiquality Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.13.4 Certiquality Main Business Overview
11.13.5 Certiquality Latest Developments
11.14 IMQ
11.14.1 IMQ Company Information
11.14.2 IMQ Medical Device Regulation (MDR) Certification Service Product Offered
11.14.3 IMQ Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.14.4 IMQ Main Business Overview
11.14.5 IMQ Latest Developments
11.15 Kiwa
11.15.1 Kiwa Company Information
11.15.2 Kiwa Medical Device Regulation (MDR) Certification Service Product Offered
11.15.3 Kiwa Medical Device Regulation (MDR) Certification Service Revenue, Gross Margin and Market Share (2019-2024)
11.15.4 Kiwa Main Business Overview
11.15.5 Kiwa Latest Developments
12 Research Findings and Conclusion
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*If Applicable.