Medical Device Testing And Certification Market

Market Overview

The global medical device testing and certification market size was valued at USD 10.6 billion in 2023. It is estimated to reach an expected USD 15.83 billion by 2032, registering a CAGR of 5.2% during the forecast period (2024-2032).

Pharmaceutical products and medical devices need to follow standards for quality assurance. Product validation and verification aim to ensure that the product works efficiently per its intended purpose. The increasing demand for the validation and verification of medical devices, the growing consumption of medical devices in developing countries, the harmonization of standards, imposition of rigorous government regulations, and the growing trend of outsourcing medical device testing services and standards are expected to drive the demand for medical device testing and certification over the forecast period.

Market Dynamics

Medical Device Testing And Certification Market Drivers

Increasing Need for Validation and Verification (V&V) for Medical device

Effective and well-documented validation and verification activities are fundamental, as they provide the highest-quality designs and production processes. The rate of mistakes in medical devices is lowered, less redesign is required, and a faster production process can be ensured with the help of validation and verification. These advancements associated with validation and verification are boosting the overall market growth.

The increasing development of medical devices and the growing complexity concerning product designing and engineering are increasing the need for validation and verification (V&V) services. Medical devices are becoming smaller and more complex, owing to the incorporation of software. The complexities in requirements and customer needs have made medical devices more difficult, increasing the demand for validation and verification.

Moreover, the rising prevalence of chronic illnesses, like cancer, is increasing the demand for developing advanced technologies, raising the need for validation and verification. Validation and verification are more standardized than in the past, which has streamlined the manufacturing and approval processes. It is further enhanced by automated testing and powerful diagnostic and data collection tools. Owing to the factors mentioned above, it is evident that the validation and verification process is becoming critical, positively influencing the overall market growth.

Compliance of Standards

Compliance with the standard is essential to protect patient safety, maintain the manufacturer's reputation, and minimize the chances of product recalls due to any adverse effect of the device. Due to many recalls, the government and the manufacturers are strictly following the guidelines for medical devices.

National regulatory authorities of every country expect manufacturers to comply with the standard guidelines and check it by a third-party certification system, which is expected to propel the medical device testing and certification market and increase easy market access. Since guidelines are distinctive in each nation, every medical device manufacturer needs to enroll or get administrative rules of that particular nation, which demonstrates the requirement for approved third parties to enlist their devices.

Hence, from the factors mentioned above, the demand for medical testing and certification increases, which will further propel the growth of the overall market during the forecast period.

Medical Device Testing And Certification Market Restraint

Diversity in Regulation

The standard guidelines of medical devices vary from country to country, which is mandatory for all manufacturers to follow for marketing or selling their products. Regulations are different in every country. The United States follows the FDA guidelines, Europe considers CE approval, Canada needs Health Canada Registration, and India requires the Central Drugs Standard Control Organization (CDSCO) approval. This varied range of supervisory landscape energies the testing and certification market. If a company wants to increase sales to different countries, the various rules and the diversity of regulations hinder the process as it is costly and tedious.

Moreover, excessive regulations, particularly in the domestic context, can also be an obstacle to local innovation of these medical devices. This will potentially hinder domestic innovation by subjecting new technologies to a lengthy and expensive licensing procedure. The excessive regulations will subsequently increase the cost and time that need to spend, in addition to the manufacturing cost of the medical devices.

Hence, all these factors mentioned above, such as excessive regulation and different regulations in different countries, are challenging to launch medical devices globally, further obstructing the overall market growth.

Medical Device Testing And Certification Market Opportunities

Acquisition Opportunities

Manufacturers are heavily investing in testing and certification, as these devices need to comply with stringent regulations. In addition, as major pharmaceutical and biopharmaceutical companies have been increasing their focus on developing numerous therapeutics and medical devices to provide effective treatment for various chronic diseases, the need for medical device testing and certification services is expected to grow in the future.

North American Science Associates, a US-based business that offers to test and consulting services to manufacturers of medical devices, was purchased by the French-based private equity group ArchiMed in September 2020. Additionally, in August 2020, Biogroup-LCD stated that it acquired Medisch Labo Medina, a testing and diagnosing medical lab located in Belgium. Further, another business, SGS, disclosed in January 2020 that it had received Stephens & Associates, a US-based provider of contract research, safety, and efficacy testing for pharmaceutical, device, cosmetic, and personal care goods.

Hence, from the development mentioned above, it is evident that medical device testing companies are making acquisitions to broaden their sector coverage. They are continuously involved in strategic investments in medical device testing services, creating tremendous opportunities for overall market growth.

Regional Analysis

By region, the global medical device testing and certification market is segmented into North America, Europe, Asia Pacific, and LAMEA.

North America accounted for the largest market share and is estimated to grow at a CAGR of 4.3% during the forecast period. In the United States, the Food and Drug Administration (FDA) regulates the process of medical device testing and certifications. In February 2019, FDA issued guidance that expanded the Abbreviated 510(k) Program for medical device development and premarket notification submissions. In this expanded guidance FDA has operationalized a new pathway for device approval. In this pathway, a 510(k) eligible device manufacturer could obtain clearance by meeting FDA-identified performance criteria to demonstrate substantial equivalence. Later, in September 2019, the FDA issued several draft guidance identifying performance criteria and testing methodologies for specific devices within four class II device types. These developments and regulations amendment by the FDA has been making the product approval process easy while enforcing devices to meet the validation and verification criteria expected to fuel the market growth.

Europe is the second largest region. It is estimated to reach an expected value of USD 3,435 million by 2030, registering a CAGR of 4%. Germany has an advanced and robust medical equipment market. The established companies such as Siemens, Carl Zeiss, and Draegerwerk. Germany claims to have the third-largest medical technology market in the world, behind the United States and Japan.

Additionally, it is by far Europe's largest market. The demand for testing and certifications is anticipated to rise as the size of the medical device market also does. All medical devices marketed in Germany must pass medical device testing and certification procedures. Medical device sales in Germany are subject to strict safety, certification, and directive requirements set forth by German and European Union (EU) directives, standards, and safety rules. In May 2021, the EU Medical Device Regulation (MDR)) is expected to come into force, further increasing medical device testing, certification, and compliance requirements in Germany.

 The Asia Pacific is the third largest region. China represents one of the major medical device industries in the Asia-Pacific Region. The Chinese government requires each medical device to undergo proper testing and standard compliance procedures before the commercial launch in the Chinese market. The National Medical Products Administration (NMPA), formerly the China Food and Drug Administration, requires in-country testing and extensive clinical data for most medical devices. The Chinese State Council passed new Medical Device Regulations. The new regulations have strengthened post-market scrutiny on product safety and have imposed penalties on the manufacturers. The new guidelines have also increased liabilities for non-compliance with the standards. For example, manufacturing and distributing unapproved medical devices can lead to fines of 15-30 times the sales value. This regulation will further increase the demand for medical testing and standard certifications, as manufacturers will increase their focus on safety and risk assessment before commercializing medical devices in China.

Segmental Analysis

The global medical device testing and certification market are segmented by service type, sourcing type, device class, technology, and region. 

By Service Type

Testing services dominate the Medical Device Testing and Certification market because they are foundational to ensuring device safety, efficacy, and regulatory compliance. This segment includes crucial procedures such as biocompatibility, mechanical, electrical, and software testing. With increasing complexities in medical devices, especially those incorporating advanced technologies like AI, robust testing is imperative. Regulatory bodies like the FDA and EU MDR mandate comprehensive testing to validate performance and safety before market entry. Continuous advancements in medical device technologies and the rise in innovative device launches further fuel the demand for testing services, making them the most critical and sought-after in this category.

By Sourcing Type:

Outsourced testing and certification services dominate over in-house operations due to cost efficiency and access to specialized expertise. Many medical device manufacturers prefer partnering with third-party service providers who have established testing infrastructure, regulatory knowledge, and technical proficiency. This approach allows manufacturers to focus on core activities like R&D and marketing while leveraging external expertise for compliance and certification. Outsourcing is particularly advantageous for small and medium-sized enterprises that may lack the resources for comprehensive in-house testing capabilities. The growing complexity of medical devices and stringent regulatory requirements make outsourcing a practical and effective choice for many companies.

By Device Class:

Class II medical devices represent the largest segment within this classification, encompassing a wide range of moderately complex and risk-bearing devices, such as infusion pumps and powered wheelchairs. These devices require more stringent regulatory controls than Class I devices but are less complex than Class III devices, which include life-supporting implants. The significant market presence of Class II devices is driven by their broad applications in various medical fields, from diagnostics to patient care. Their balanced regulatory requirements, offering both a manageable compliance pathway and the necessity for detailed safety and efficacy data, contribute to their dominant market share.

By Technology:

In Vitro Diagnostic (IVD) medical devices are the leading segment due to their critical role in disease detection and monitoring. These devices facilitate early diagnosis and continuous health management, essential in managing chronic diseases and improving patient outcomes. The COVID-19 pandemic significantly boosted the demand for IVDs, particularly for diagnostic tests, highlighting their importance in public health. Continuous innovation in molecular diagnostics, point-of-care testing, and personalized medicine further propels the IVD segment. With their vast applicability across medical specialties and routine health assessments, IVD devices are central to modern healthcare.

By End User:

Medical device manufacturers are the primary end users of testing and certification services. These companies must ensure that their products comply with global regulatory standards before they can enter the market. Manufacturers rely heavily on testing and certification to verify the safety, functionality, and regulatory compliance of their devices. The increasing pace of technological innovation and the need to meet stringent regulatory requirements drive manufacturers to engage extensively with testing and certification services. This dependency underscores their dominance as they strive to bring innovative, safe, and effective medical devices to market while maintaining compliance with diverse global regulations.

Recent Developments

• August 2022 - TÜV Rheinland has granted the world's first certification for a drone following the new EU regulation for civil unmanned aircraft systems (UAS) as an official Notified Body.
• June 2022 - Conenergy and TÜV Rheinland have partnered to increase services along the whole hydrogen value chain and to aid clients in their transition to a more sustainable energy source.