MEDICAL DEVICE TESTING AND CERTIFICATION MARKET ANALYSIS

The global medical device testing and certification market was valued at US$ 9,687.7 Mn in 2022 and is forecast to reach a value of US$ 13,550.8 Mn by 2030 at a CAGR of 4.3% between 2023 and 2030. The medical device testing and certification market is experiencing strong growth due to the rise in focus on the medical device testing and certification and stringent government regulations. Moreover, the outbreak of COVID-19 and increase in usage of AI and IoT in medical devices is expected to boost the growth of the market. However, factors such as diversity in regulations and the outbreak of COVID-19 are expected to hamper growth of the market.

Global Medical Device Testing and Certification Market: Regional Insights

Based on geography, the global medical device testing and certification market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period due to the stringent government regulations, the outbreak of COVID-19, and rising demand for verification and validation of medical devices. For instance, the Food and Drug Administration (FDA) is responsible for regulating medical devices in the United States. FDA regulates medical devices to assure their safety and effectiveness and develops, and carries out the national program designed to control unnecessary exposures to, and assure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products.

Europe and Asia Pacific are also expected to witness robust growth in the global medical device testing and certification market due to the outbreak of COVID-19, increase in focus on the quality of the medical devices, and strict government regulations in these regions. For instance, competent authorities, notified bodies, and authorized representatives are all involved in CE marking process. Medical devices are regulated at the EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Manufacturers can place the CE mark on a medical device once it has passed a conformity assessment.

Figure 1. Global Medical Device Testing and Certification Market Share (%), By Region, 2023

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Global Medical Device Testing and Certification Market Drivers:

Rise in focus on medical device testing to augment market growth

One of the key factors expected to augment the growth of the global medical device testing and certification market during the forecast period is the rise in focus on the medical device testing and certification. For instance, in January 2022, TÜV SÜD planned to expand its Medical and Health Services (MHS) facilities in New Brighton, Minnesota. A new laboratory will offer an end-to-end testing solution for all medical devices and will provide a range of biological and chemical testing of medical devices that complements TÜV’s current active medical device testing capabilities.

Strict government regulations to underpin market growth

Another factor which is driving the growth of the global medical device testing and certification market is the strict government regulations around the world. For instance, the standard guidelines of medical devices vary from country to country, and it is mandatory for manufacturers to follow these guidelines for marketing or selling of their medical products in the country. For instance, the U.S. follows the Food and Drug Administration (FDA) guidelines, Europe considers Conformitè Europëenne (CE) approval, Canada needs the Health Canada Registration, and India need approval from the Central Drugs Standard Control Organisation (CDSCO).

Global Medical Device Testing and Certification Market Opportunities:

The outbreak of COVID-19 is expected to provide significant growth opportunities for players in the global medical device testing and certification market. For instance, the outbreak of COVID-19 increased demand for medical device testing and certification services worldwide. In 2020, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) for medical devices to diagnose COVID-19 as well as Personal Protective Equipment (PPE) needed to protect both healthcare providers and patients. The medical testing and certification continues and has taken a fast phase during the COVID 19 situation.

Increase in use of Artificial Intelligence (AI) and Internet of Things (IoT) in medical devices is expected to offer significant growth opportunities for players in the global medical device testing and certification market. For instance, deployment of advanced technologies, such as AI and IoT, along with a focus on real-time patient monitoring, have created a complex ecosystem for medical devices. To receive a marketing authorization, these devices must undergo methodical testing and need to comply with stringent regulations. Hence, market players or manufacturers are investing heavily to test their devices and receive a marketing authorization.

Global Medical Device Testing and Certification Market Trends:

Need for medical device testing/certification is a recent trend

Medical devices are regulated by various regulatory authorities across the globe. This is primarily because end users of these devices expect excellent performance, safety, and effectiveness from these devices. Therefore, it is imperative for manufacturers to properly implement a medical device testing strategy, which makes the device effective and eases the production process. This trend is expected to continue over the forecast period, driving the market growth.

Outsourcing of testing and certification is another trend

The demand for outsourcing testing services to third-party vendors is increasing with a rapid pace due to the capital-intensive nature of the in-house testing. Thus, several manufacturers worldwide or players are increasingly outsourcing testing services as stringent regulations make it costly to conduct in-house tests, and thereby helping these firms reduce the overall cost of the testing. This trend is also expected to continue over the forecast period, driving the market growth.

Global Medical Device Testing and Certification Market Restraints:

Diversity in regulations to hinder growth of the market

One of the key factors expected to hamper the growth of the global medical device testing and certification market is the diversity in regulations or stringent rules and regulations. The standard guidelines of medical device vary from country to country; which is mandatory for manufacturers to follow, for marketing or selling their products in the country. Regulations are different in every country. Therefore, for medical device manufacturers, it is very crucial to register and/or receive the regulatory guidelines of that specific country. 

The outbreak of COVID-19 to hamper market growth

Another factor which is hampering the growth of the global medical device testing and certification market is the outbreak of COVID-19. The pandemic has increased the demand for medical device testing and certification services. Though there are exemption and leverages in the regulations, the medical testing/certification continues and has taken a fast phase during the pandemic. However, the pandemic had a slight impact on the market as the testing of other medical devices, which are not an emergent, were put on hold.

Figure 2. Global Medical Device Testing and Certification Market Share (%), By Service Type, 2023

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Global Medical Device Testing and Certification Market Segmentation:

The global medical device testing and certification market report is segmented into Service Type, Sourcing Type, Device Class, Technology, and Geography.

Based on Service Type, the market is segmented into Testing Services, Inspection Services, and Certification Services. Of which, Testing Services Segment is expected to dominate the medical device testing and certification market over the forecast period and this is attributed to the increase in demand for safe and effective medical devices.

Inspection Services Segment is also expected to witness significant growth in the near future and this is owing to the stringent rules and regulations. Inspection services help reduce costs, minimize risk, and provide the expected quality.

Based on Sourcing Type, the market is segmented into In-house and Outsourced. Out of which, Outsourced Segment is expected to dominate the market during the forecast period and this is attributed to the growing trend of outsourcing medical devices testing services.

Based on Device Class, the market is segmented into Class I, Class II, and Class III. Out of which, Class I Segment is expected to dominate the market over the forecast period and this is attributed to the increasing demand for Class I medical devices. Based on the risks associated with the use of medical device, these devices are classified as Class I, Class II, or Class III. The classification depends upon the level of risk that is associated with the device.

Class II Segment is also expected to witness significant growth in the near future and this is owing to increasing demand for Class II medical devices.

Based on Technology, the market is segmented into Active Implant Medical Device, Active Medical Device, Non-Active Medical Device, In-Vitro Diagnostic Medical Device, Ophthalmic Medical Device, Orthopedic and Dental Medical Device, Vascular Medical Device, and Other Technologies. Out of which, Active Implant Medical Device Segment is expected to dominate the market over the forecast period and this is attributed to the rise in demand for active implant medical devices (AIMDs). As one of the highest risk categories of device, AIMDs are subject to rigorous regulatory controls before they can reach global markets.

In-Vitro Diagnostic Medical Device Segment is also expected to witness significant growth in the near future and this is due to increase in focus on early diagnosis (due to rise in burden of life-threatening disease worldwide). In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person's health.

Global Medical Device Testing and Certification Market: Key Developments

In February 2021, Alfa Medical (AMG) planned to invest EUR 263.5 million in the market over the next five years, in order to expand Egypt’s healthcare market, including increasing the number of laboratories, production facilities, and standards.

In February 2021, BSI certified Abbott’s neuromodulation clinician programmer application and its patient controller app, for use on compatible personal Apple smartphone devices, to the Medical Devices Regulation (MDR) (EU 2017/745) via its Notified Body in the Netherlands (2797).

In April 2021, TÜV SÜD announced that it had presented itself at Medtec LIVE to exhibit its ability to be a one-stop-shop for medical device testing.

In October 2020, TÜV Rheinland announced the opening of its Biomaterial and Electro Magnetic Compatibility (EMC) Testing Laboratories located at Andhra Pradesh MedTech Zone (AMTZ), Visakhapatnam (Andhra Pradesh), India.

Global Medical Device Testing and Certification Market: Key Companies Insights

The global medical device testing and certification market is highly competitive. This is attributed to the need for medical device testing and certification worldwide, as a result, players in the market are focusing on launching novel products in the market.

Some of the key players in the global medical device testing and certification market are Medistri SA, BSI Group, Ente Certificazione Macchine, GMED, IMQ Group SRL, TOXIKON, TÜV SÜD, WuXi AppTec, Pace Analytical Services LLC, Gateway Analytical LLC, Boston Analytical, Bureau Veritas, UL LLC, TUV Rheinland, SGS SA, Intertek Group PLC, Eurofins Scientific, Element Materials Technology, Dekra Testing and Certification GmbH, and Institute for testing and Certification Inc., among others.

*Definition: Medical device testing & certification is necessary to ensure safety and effectiveness of medical devices. The U.S. follows the Food & Drug Administration (FDA) guidelines, Canada needs the Health Canada Registration, Europe considers Conformitè Europëenne (CE) approval, and India need approval from the Central Drugs Standard Control Organisation (CDSCO).