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Global Medical Device Regulation (MDR) Certification Service Market 2024 by Company, Regions, Type and Application, Forecast to 2030

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1 Market Overview

  • 1.1 Product Overview and Scope
  • 1.2 Market Estimation Caveats and Base Year
  • 1.3 Market Analysis by Type
    • 1.3.1 Overview: Global Medical Device Regulation (MDR) Certification Service Consumption Value by Type: 2019 Versus 2023 Versus 2030
    • 1.3.2 Assessment and Certification Services
    • 1.3.3 Training、Assessment and Certification Services
    • 1.3.4 Others
  • 1.4 Market Analysis by Application
    • 1.4.1 Overview: Global Medical Device Regulation (MDR) Certification Service Consumption Value by Application: 2019 Versus 2023 Versus 2030
    • 1.4.2 Manufacturers of Medical Devices
    • 1.4.3 Authorized Representatives of Medical Devices
    • 1.4.4 Importers and Distributors of Medical Devices
    • 1.4.5 Research and Development Organizations and Medical Innovation Companies
    • 1.4.6 Others
  • 1.5 Global Medical Device Regulation (MDR) Certification Service Market Size & Forecast
    • 1.5.1 Global Medical Device Regulation (MDR) Certification Service Consumption Value (2019 & 2023 & 2030)
    • 1.5.2 Global Medical Device Regulation (MDR) Certification Service Sales Quantity (2019-2030)
    • 1.5.3 Global Medical Device Regulation (MDR) Certification Service Average Price (2019-2030)

2 Manufacturers Profiles

  • 2.1 TÜV Rheinland
    • 2.1.1 TÜV Rheinland Details
    • 2.1.2 TÜV Rheinland Major Business
    • 2.1.3 TÜV Rheinland Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.1.4 TÜV Rheinland Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.1.5 TÜV Rheinland Recent Developments/Updates
  • 2.2 DQS
    • 2.2.1 DQS Details
    • 2.2.2 DQS Major Business
    • 2.2.3 DQS Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.2.4 DQS Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.2.5 DQS Recent Developments/Updates
  • 2.3 Intertek
    • 2.3.1 Intertek Details
    • 2.3.2 Intertek Major Business
    • 2.3.3 Intertek Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.3.4 Intertek Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.3.5 Intertek Recent Developments/Updates
  • 2.4 DEKRA
    • 2.4.1 DEKRA Details
    • 2.4.2 DEKRA Major Business
    • 2.4.3 DEKRA Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.4.4 DEKRA Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.4.5 DEKRA Recent Developments/Updates
  • 2.5 SGS Société Générale de Surveillance SA
    • 2.5.1 SGS Société Générale de Surveillance SA Details
    • 2.5.2 SGS Société Générale de Surveillance SA Major Business
    • 2.5.3 SGS Société Générale de Surveillance SA Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.5.4 SGS Société Générale de Surveillance SA Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.5.5 SGS Société Générale de Surveillance SA Recent Developments/Updates
  • 2.6 RISE
    • 2.6.1 RISE Details
    • 2.6.2 RISE Major Business
    • 2.6.3 RISE Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.6.4 RISE Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.6.5 RISE Recent Developments/Updates
  • 2.7 BSI
    • 2.7.1 BSI Details
    • 2.7.2 BSI Major Business
    • 2.7.3 BSI Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.7.4 BSI Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.7.5 BSI Recent Developments/Updates
  • 2.8 DNV MEDCERT GmbH
    • 2.8.1 DNV MEDCERT GmbH Details
    • 2.8.2 DNV MEDCERT GmbH Major Business
    • 2.8.3 DNV MEDCERT GmbH Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.8.4 DNV MEDCERT GmbH Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.8.5 DNV MEDCERT GmbH Recent Developments/Updates
  • 2.9 Eurofins
    • 2.9.1 Eurofins Details
    • 2.9.2 Eurofins Major Business
    • 2.9.3 Eurofins Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.9.4 Eurofins Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.9.5 Eurofins Recent Developments/Updates
  • 2.10 ITC ZLÍN
    • 2.10.1 ITC ZLÍN Details
    • 2.10.2 ITC ZLÍN Major Business
    • 2.10.3 ITC ZLÍN Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.10.4 ITC ZLÍN Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.10.5 ITC ZLÍN Recent Developments/Updates
  • 2.11 3EC International
    • 2.11.1 3EC International Details
    • 2.11.2 3EC International Major Business
    • 2.11.3 3EC International Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.11.4 3EC International Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.11.5 3EC International Recent Developments/Updates
  • 2.12 CE Certiso
    • 2.12.1 CE Certiso Details
    • 2.12.2 CE Certiso Major Business
    • 2.12.3 CE Certiso Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.12.4 CE Certiso Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.12.5 CE Certiso Recent Developments/Updates
  • 2.13 Certiquality
    • 2.13.1 Certiquality Details
    • 2.13.2 Certiquality Major Business
    • 2.13.3 Certiquality Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.13.4 Certiquality Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.13.5 Certiquality Recent Developments/Updates
  • 2.14 IMQ
    • 2.14.1 IMQ Details
    • 2.14.2 IMQ Major Business
    • 2.14.3 IMQ Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.14.4 IMQ Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.14.5 IMQ Recent Developments/Updates
  • 2.15 Kiwa
    • 2.15.1 Kiwa Details
    • 2.15.2 Kiwa Major Business
    • 2.15.3 Kiwa Medical Device Regulation (MDR) Certification Service Product and Services
    • 2.15.4 Kiwa Medical Device Regulation (MDR) Certification Service Sales Quantity, Average Price, Revenue, Gross Margin and Market Share (2019-2024)
    • 2.15.5 Kiwa Recent Developments/Updates

3 Competitive Environment: Medical Device Regulation (MDR) Certification Service by Manufacturer

  • 3.1 Global Medical Device Regulation (MDR) Certification Service Sales Quantity by Manufacturer (2019-2024)
  • 3.2 Global Medical Device Regulation (MDR) Certification Service Revenue by Manufacturer (2019-2024)
  • 3.3 Global Medical Device Regulation (MDR) Certification Service Average Price by Manufacturer (2019-2024)
  • 3.4 Market Share Analysis (2023)
    • 3.4.1 Producer Shipments of Medical Device Regulation (MDR) Certification Service by Manufacturer Revenue ($MM) and Market Share (%): 2023
    • 3.4.2 Top 3 Medical Device Regulation (MDR) Certification Service Manufacturer Market Share in 2023
    • 3.4.3 Top 6 Medical Device Regulation (MDR) Certification Service Manufacturer Market Share in 2023
  • 3.5 Medical Device Regulation (MDR) Certification Service Market: Overall Company Footprint Analysis
    • 3.5.1 Medical Device Regulation (MDR) Certification Service Market: Region Footprint
    • 3.5.2 Medical Device Regulation (MDR) Certification Service Market: Company Product Type Footprint
    • 3.5.3 Medical Device Regulation (MDR) Certification Service Market: Company Product Application Footprint
  • 3.6 New Market Entrants and Barriers to Market Entry
  • 3.7 Mergers, Acquisition, Agreements, and Collaborations

4 Consumption Analysis by Region

  • 4.1 Global Medical Device Regulation (MDR) Certification Service Market Size by Region
    • 4.1.1 Global Medical Device Regulation (MDR) Certification Service Sales Quantity by Region (2019-2030)
    • 4.1.2 Global Medical Device Regulation (MDR) Certification Service Consumption Value by Region (2019-2030)
    • 4.1.3 Global Medical Device Regulation (MDR) Certification Service Average Price by Region (2019-2030)
  • 4.2 North America Medical Device Regulation (MDR) Certification Service Consumption Value (2019-2030)
  • 4.3 Europe Medical Device Regulation (MDR) Certification Service Consumption Value (2019-2030)
  • 4.4 Asia-Pacific Medical Device Regulation (MDR) Certification Service Consumption Value (2019-2030)
  • 4.5 South America Medical Device Regulation (MDR) Certification Service Consumption Value (2019-2030)
  • 4.6 Middle East & Africa Medical Device Regulation (MDR) Certification Service Consumption Value (2019-2030)

5 Market Segment by Type

  • 5.1 Global Medical Device Regulation (MDR) Certification Service Sales Quantity by Type (2019-2030)
  • 5.2 Global Medical Device Regulation (MDR) Certification Service Consumption Value by Type (2019-2030)
  • 5.3 Global Medical Device Regulation (MDR) Certification Service Average Price by Type (2019-2030)

6 Market Segment by Application

  • 6.1 Global Medical Device Regulation (MDR) Certification Service Sales Quantity by Application (2019-2030)
  • 6.2 Global Medical Device Regulation (MDR) Certification Service Consumption Value by Application (2019-2030)
  • 6.3 Global Medical Device Regulation (MDR) Certification Service Average Price by Application (2019-2030)

7 North America

  • 7.1 North America Medical Device Regulation (MDR) Certification Service Sales Quantity by Type (2019-2030)
  • 7.2 North America Medical Device Regulation (MDR) Certification Service Sales Quantity by Application (2019-2030)
  • 7.3 North America Medical Device Regulation (MDR) Certification Service Market Size by Country
    • 7.3.1 North America Medical Device Regulation (MDR) Certification Service Sales Quantity by Country (2019-2030)
    • 7.3.2 North America Medical Device Regulation (MDR) Certification Service Consumption Value by Country (2019-2030)
    • 7.3.3 United States Market Size and Forecast (2019-2030)
    • 7.3.4 Canada Market Size and Forecast (2019-2030)
    • 7.3.5 Mexico Market Size and Forecast (2019-2030)

8 Europe

  • 8.1 Europe Medical Device Regulation (MDR) Certification Service Sales Quantity by Type (2019-2030)
  • 8.2 Europe Medical Device Regulation (MDR) Certification Service Sales Quantity by Application (2019-2030)
  • 8.3 Europe Medical Device Regulation (MDR) Certification Service Market Size by Country
    • 8.3.1 Europe Medical Device Regulation (MDR) Certification Service Sales Quantity by Country (2019-2030)
    • 8.3.2 Europe Medical Device Regulation (MDR) Certification Service Consumption Value by Country (2019-2030)
    • 8.3.3 Germany Market Size and Forecast (2019-2030)
    • 8.3.4 France Market Size and Forecast (2019-2030)
    • 8.3.5 United Kingdom Market Size and Forecast (2019-2030)
    • 8.3.6 Russia Market Size and Forecast (2019-2030)
    • 8.3.7 Italy Market Size and Forecast (2019-2030)

9 Asia-Pacific

  • 9.1 Asia-Pacific Medical Device Regulation (MDR) Certification Service Sales Quantity by Type (2019-2030)
  • 9.2 Asia-Pacific Medical Device Regulation (MDR) Certification Service Sales Quantity by Application (2019-2030)
  • 9.3 Asia-Pacific Medical Device Regulation (MDR) Certification Service Market Size by Region
    • 9.3.1 Asia-Pacific Medical Device Regulation (MDR) Certification Service Sales Quantity by Region (2019-2030)
    • 9.3.2 Asia-Pacific Medical Device Regulation (MDR) Certification Service Consumption Value by Region (2019-2030)
    • 9.3.3 China Market Size and Forecast (2019-2030)
    • 9.3.4 Japan Market Size and Forecast (2019-2030)
    • 9.3.5 South Korea Market Size and Forecast (2019-2030)
    • 9.3.6 India Market Size and Forecast (2019-2030)
    • 9.3.7 Southeast Asia Market Size and Forecast (2019-2030)
    • 9.3.8 Australia Market Size and Forecast (2019-2030)

10 South America

  • 10.1 South America Medical Device Regulation (MDR) Certification Service Sales Quantity by Type (2019-2030)
  • 10.2 South America Medical Device Regulation (MDR) Certification Service Sales Quantity by Application (2019-2030)
  • 10.3 South America Medical Device Regulation (MDR) Certification Service Market Size by Country
    • 10.3.1 South America Medical Device Regulation (MDR) Certification Service Sales Quantity by Country (2019-2030)
    • 10.3.2 South America Medical Device Regulation (MDR) Certification Service Consumption Value by Country (2019-2030)
    • 10.3.3 Brazil Market Size and Forecast (2019-2030)
    • 10.3.4 Argentina Market Size and Forecast (2019-2030)

11 Middle East & Africa

  • 11.1 Middle East & Africa Medical Device Regulation (MDR) Certification Service Sales Quantity by Type (2019-2030)
  • 11.2 Middle East & Africa Medical Device Regulation (MDR) Certification Service Sales Quantity by Application (2019-2030)
  • 11.3 Middle East & Africa Medical Device Regulation (MDR) Certification Service Market Size by Country
    • 11.3.1 Middle East & Africa Medical Device Regulation (MDR) Certification Service Sales Quantity by Country (2019-2030)
    • 11.3.2 Middle East & Africa Medical Device Regulation (MDR) Certification Service Consumption Value by Country (2019-2030)
    • 11.3.3 Turkey Market Size and Forecast (2019-2030)
    • 11.3.4 Egypt Market Size and Forecast (2019-2030)
    • 11.3.5 Saudi Arabia Market Size and Forecast (2019-2030)
    • 11.3.6 South Africa Market Size and Forecast (2019-2030)

12 Market Dynamics

  • 12.1 Medical Device Regulation (MDR) Certification Service Market Drivers
  • 12.2 Medical Device Regulation (MDR) Certification Service Market Restraints
  • 12.3 Medical Device Regulation (MDR) Certification Service Trends Analysis
  • 12.4 Porters Five Forces Analysis
    • 12.4.1 Threat of New Entrants
    • 12.4.2 Bargaining Power of Suppliers
    • 12.4.3 Bargaining Power of Buyers
    • 12.4.4 Threat of Substitutes
    • 12.4.5 Competitive Rivalry

13 Raw Material and Industry Chain

  • 13.1 Raw Material of Medical Device Regulation (MDR) Certification Service and Key Manufacturers
  • 13.2 Manufacturing Costs Percentage of Medical Device Regulation (MDR) Certification Service
  • 13.3 Medical Device Regulation (MDR) Certification Service Production Process
  • 13.4 Industry Value Chain Analysis

14 Shipments by Distribution Channel

  • 14.1 Sales Channel
    • 14.1.1 Direct to End-User
    • 14.1.2 Distributors
  • 14.2 Medical Device Regulation (MDR) Certification Service Typical Distributors
  • 14.3 Medical Device Regulation (MDR) Certification Service Typical Customers

15 Research Findings and Conclusion

    16 Appendix

    • 16.1 Methodology
    • 16.2 Research Process and Data Source

    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.
    According to our (Global Info Research) latest study, the global Medical Device Regulation (MDR) Certification Service market size was valued at US$ million in 2023 and is forecast to a readjusted size of USD million by 2030 with a CAGR of %during review period.
    This report is a detailed and comprehensive analysis for global Medical Device Regulation (MDR) Certification Service market. Both quantitative and qualitative analyses are presented by company, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2024, are provided.
    Key Features:
    Global Medical Device Regulation (MDR) Certification Service market size and forecasts, in consumption value ($ Million), 2019-2030
    Global Medical Device Regulation (MDR) Certification Service market size and forecasts by region and country, in consumption value ($ Million), 2019-2030
    Global Medical Device Regulation (MDR) Certification Service market size and forecasts, by Type and by Application, in consumption value ($ Million), 2019-2030
    Global Medical Device Regulation (MDR) Certification Service market shares of main players, in revenue ($ Million), 2019-2024
    The Primary Objectives in This Report Are:
    To determine the size of the total market opportunity of global and key countries
    To assess the growth potential for Medical Device Regulation (MDR) Certification Service
    To forecast future growth in each product and end-use market
    To assess competitive factors affecting the marketplace
    This report profiles key players in the global Medical Device Regulation (MDR) Certification Service market based on the following parameters - company overview, revenue, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include TÜV Rheinland, DQS, Intertek, DEKRA, SGS Société Générale de Surveillance SA, RISE, BSI, DNV MEDCERT GmbH, Eurofins, ITC ZLÍN, etc.
    This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
    Market segmentation
    Medical Device Regulation (MDR) Certification Service market is split by Type and by Application. For the period 2019-2030, the growth among segments provides accurate calculations and forecasts for Consumption Value by Type and by Application. This analysis can help you expand your business by targeting qualified niche markets.
    Market segmentation
    Medical Device Regulation (MDR) Certification Service market is split by Type and by Application. For the period 2018-2029, the growth among segments provides accurate calculations and forecasts for Consumption Value by Type and by Application. This analysis can help you expand your business by targeting qualified niche markets.
    Market segment by Type
    Assessment and Certification Services
    Training、Assessment and Certification Services
    Others
    Market segment 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
    Market segment by players, this report covers
    TÜV Rheinland
    DQS
    Intertek
    DEKRA
    SGS Société Générale de Surveillance SA
    RISE
    BSI
    DNV MEDCERT GmbH
    Eurofins
    ITC ZLÍN
    3EC International
    CE Certiso
    Certiquality
    IMQ
    Kiwa
    Market segment by regions, regional analysis covers
    North America (United States, Canada and Mexico)
    Europe (Germany, France, UK, Russia, Italy and Rest of Europe)
    Asia-Pacific (China, Japan, South Korea, India, Southeast Asia and Rest of Asia-Pacific)
    South America (Brazil, Rest of South America)
    Middle East & Africa (Turkey, Saudi Arabia, UAE, Rest of Middle East & Africa)
    The content of the study subjects, includes a total of 13 chapters:
    Chapter 1, to describe Medical Device Regulation (MDR) Certification Service product scope, market overview, market estimation caveats and base year.
    Chapter 2, to profile the top players of Medical Device Regulation (MDR) Certification Service, with revenue, gross margin, and global market share of Medical Device Regulation (MDR) Certification Service from 2019 to 2024.
    Chapter 3, the Medical Device Regulation (MDR) Certification Service competitive situation, revenue, and global market share of top players are analyzed emphatically by landscape contrast.
    Chapter 4 and 5, to segment the market size by Type and by Application, with consumption value and growth rate by Type, by Application, from 2019 to 2030.
    Chapter 6, 7, 8, 9, and 10, to break the market size data at the country level, with revenue and market share for key countries in the world, from 2019 to 2024.and Medical Device Regulation (MDR) Certification Service market forecast, by regions, by Type and by Application, with consumption value, from 2024 to 2030.
    Chapter 11, market dynamics, drivers, restraints, trends, Porters Five Forces analysis.
    Chapter 12, the key raw materials and key suppliers, and industry chain of Medical Device Regulation (MDR) Certification Service.
    Chapter 13, to describe Medical Device Regulation (MDR) Certification Service research findings and conclusion.

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