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Medical Device Testing and Certification Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

Published: | Mordor Intelligence Pvt Ltd | 121 Pages | Delivery time: 2-3 business days


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Medical Device Testing and Certification Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)
Published: April 21, 2021
Mordor Intelligence Pvt Ltd
Content info: 121 Pages
Delivery time: 2-3 business days
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The Medical Device Testing and Certification Market is expected to grow with a CAGR of 5.4% during the forecast period.

During the COVID-19 pandemic 2020, several measures were taken in order to prevent the transmission of diseases such as lockdown measurements and restricting import-export activities between the countries which has disrupted the supply chain and thereby negatively impacted the overall market studied.

Moreover, the disruption caused due to COVID-19 in international supply chains has led to shortages of critical medical devices across the globe. Therefore, many countries have taken definite measurements in order to ease the shortages by importing equipment such as domestic manufacturing of medical devices. In addition, domestic manufacturing of essential medical devices is expected overcome trade barriers, at the same time ensure product quality and market stability.

As per British Standards Institution (BSI), in February 2020, by taking into consideration the effects of the COVID-19 pandemic, the company reviewed processes and planned a program, to minimize the risk to British Standards Institution (BSI) clients and colleagues whilst maintaining accreditation requirements and mitigating potential global trade risks.

The medical devices are subjected to comply with strict regulatory protocols, as it is vital to ensure the efficacy and safety of medical devices. Therefore, it is compulsory for every device to comply with national and international standards before entering a market. The standard guidelines of medical devices vary from country to country, and it is mandatory for every manufacturer to follow these guidelines for marketing or selling of their products in a country. For instance, the United States follows Food and Drug Administration (FDA) guidelines, Europe considers Conformite Europeenne (CE) approval, Canada needs Health Canada Registration, and India requires approval from Central Drugs Standard Control Organisation (CDSCO). This diverse range of regulatory landscape drives the testing and certification market.

Since regulations are different in every country, it is crucial for each medical device manufacturer to register or receive regulatory guidelines of that specific country, which, in turn, indicates the need for authorized third-parties to register their devices. National regulatory authorities of every country prefer that the manufacturers selling their products in that particular country should comply with standard guidelines, and get it checked by a third-party certification system.

This can result in propelling the testing and certification market, as well as increase easy market access. The other factors, such as increasing need of validation and verification (V&V) for medical devices are driving the medical device testing and certification market. However, factor such as diversity in regulation is expected to impede market growth over the forecast period.

Key Market Trends

Testing Services Segment is Expected to Witness a Rapid Growth During the Forecast Period

Globally, medical devices are regulated by various regulatory authorities and compliances. This is mainly because the end-users of these devices expect outstanding performance, effectiveness, and safety from these medical devices. Therefore, it is mandatory for the manufacturers to properly define and implement medical device testing strategy which makes the device effective and production becomes easier due to the confirmation of quality.

Due to the COVID-19 pandemic, in April 2020, the European Commission (EC) adopted a proposal, to postpone the application date of the Medical Device Regulation (MDR) for one year beacuse the COVID-19 pandemic increased demand for certain medical devices, which were crucial to avoid risks or difficulties of potential shortages of such devices. And also, the COVID-19 pandemic has delayed clinical trials and disrupted processes for medical devices.

While some of the medical devices experienced a sudden surge in the demand during the COVID-19 pandemic 2020. For instance, ventilators were in high demand for COVID - 19 patients as they are an important tool in hospitals that can keep the patients in critical conditions alive. For instance, in March 2020, Medtronic announced that it has increased production by more than 40% to date and is on track to more than double its capacity to manufacture and supply ventilators in response to the urgent needs of patients and healthcare systems across the world confronting COVID-19.​

In February 2019, Microsoft and Bureau Veritas entered into a collaboration for the development of laboratory testing services based on artificial intelligence (AI). Such an initiatives by the market players will also boost the segment growth in near future.

An effective medical device testing strategy needs several sets of test requirements. The sets of requirements are required to smoothen test implementation as tests are carried out continuously at different stages of the complete manufacturing process, from component selection to a final assembly of a medical device, and each stage has different requirements and different parameters to be satisfied. Thus, increasing medical devices will also increase these testing services, which is expected to augment the overall growth of the market.

North America Dominates the Market and is Expected to do the Same over the Forecast Period

Some of the factors that are driving the market growth in North America region include increased focus on the quality of the medical devices and the presence of a large number of companies that serve the medical device industry along with presence of well-developed healthcare and the presence of top multinational medical device companies.

According to a research article by A. Chandimal Nicholas published in May 2020, in Canada, during COVID-19 pandemic 2020, the Minister of Health has signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in relation to COVID-19 which allowed expedited access to COVID-19 medical devices for use by healthcare providers. Moreover, as per Health Canada, the Interim Order helped for quick approval of the importation and sale of COVID-19 medical devices.

In addition, during COVID-19 pandemic 2020, in the United States, the Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) for medical devices to diagnose COVID-19 as well as Personal protective equipment needed to protect healthcare providers interacting with patients.

In the United States, medical devices are managed by the Food and Drug Administration (FDA) to guarantee the safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an Food and Drug Administration (FDA) segment. Class II devices require remarkable controls for "labelling, guidance, tracking, plan, performance standards, and post-market observation," and most require premarket notification 510(k) to appraise substantial equivalence to a lawfully marketed device.

According to the Center for Medicare & Medicaid Services, United States health care spending grew 4.6 percent in 2018, reaching USD 3.6 trillion or USD 11,172 per person. As a share of the nation's Gross Domestic Product, health spending accounted for 17.7 percent. Moreover, with increasing approval of medical devices in the region rise demand for medical device testing services which will boost the market growth. Thus, considering above mentioned factors it is expected to fuel the market growth in North America region over the forecast period.

Competitive Landscape

The Medical Device Testing and Certification Market is highly consolidated and there are few companies that are providing the testing and certification services. It has been observed that with the growing medical device market, more companies are expected to enter the market in the near future. Substantial market share will be gained by the small to mid-sized companies in the coming years. Some of the market players include BSI Group, Intertek Group plc, Institute for Testing and Certification Inc., Eurofins Scientific, SGS SA and others.

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Table of Contents
Product Code: 62575



  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study




  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Increasing Need of Validation and Verification (V&V) for Medical Devices
    • 4.2.2 Compliance of Standards
  • 4.3 Market Restraints
    • 4.3.1 Diversity in Regulation
  • 4.4 Porter's Five Force Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry


  • 5.1 By Service Type
    • 5.1.1 Testing Services
    • 5.1.2 Inspection Services
    • 5.1.3 Certification Services
    • 5.1.4 Other Services
  • 5.2 By Sourcing Type
    • 5.2.1 In-House
    • 5.2.2 Outsourced
  • 5.3 By Device Class
    • 5.3.1 Class I
    • 5.3.2 Class II
    • 5.3.3 Class III
  • 5.4 By Technology
    • 5.4.1 Active Implant Medical Device
    • 5.4.2 Active Medical Device
    • 5.4.3 Non-Active Medical Device
    • 5.4.4 In-Vitro Diagnostic Medical Device
    • 5.4.5 Ophthalmic Medical Device
    • 5.4.6 Orthopedic and Dental Medical Device
    • 5.4.7 Other Technologies
  • 5.5 Geography
    • 5.5.1 North America
      • United States
      • Canada
      • Mexico
    • 5.5.2 Europe
      • Germany
      • United Kingdom
      • France
      • Italy
      • Spain
      • Rest of Europe
    • 5.5.3 Asia-Pacific
      • China
      • Japan
      • India
      • Australia
      • South Korea
      • Rest of Asia-Pacific
    • 5.5.4 Middle East and Africa
      • GCC
      • South Africa
      • Rest of Middle East and Africa
    • 5.5.5 South America
      • Brazil
      • Argentina
      • Rest of South America


  • 6.1 Company Profiles
    • 6.1.1 BSI Group
    • 6.1.2 Dekra Testing and Certification GmbH
    • 6.1.3 Eurofins Scientific
    • 6.1.4 Institute for testing and Certification Inc.
    • 6.1.5 Intertek Group PLC
    • 6.1.6 SGS SA
    • 6.1.7 TUV Rheinland
    • 6.1.8 UL LLC
    • 6.1.9 Bureau Veritas
    • 6.1.10 Element Materials Technology
    • 6.1.11 Avomeen
    • 6.1.12 Gateway Analytical, LLC
    • 6.1.13 Medistri SA
    • 6.1.14 Pace Analytical Services, LLC
    • 6.1.15 WuXi AppTec