Increasing Demand from Healthcare Facilities Is Augmenting the Growth of the Global Medical Device Testing and Certification Market

Medical Device Testing and Certification Market

Medical Device Testing and Certification Market, By Service Type (Testing Services, Inspection Services, and Certification Services), By Sourcing Type (In-house and Outsourced), By Device Class (Class I, Class II, and Class III), By Technology (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), and By Geography (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)- Size, Share, Outlook, and Opportunity Analysis, 2023 - 2030.

Market Overview:

Medical device testing and certification refer to the processes and procedures carried out to ensure that medical devices meet regulatory requirements, safety standards, and performance expectations. It involves comprehensive testing, evaluation, and documentation of medical devices to demonstrate their safety, efficacy, and compliance with applicable regulations and standards set by regulatory bodies.

Competitive Landscape:

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

Key Market Drivers:

Governments and regulatory authorities worldwide have established stringent regulations and standards to ensure the safety and quality of medical devices. Compliance with these regulations is essential for manufacturers to market their products. The increasing focus on regulatory compliance drives the demand for medical device testing and certification services. This is expected to augment the growth of the global medical device testing and certification market.

Medical devices are becoming increasingly complex, incorporating advanced technologies such as wireless connectivity, software algorithms, and artificial intelligence. The testing and certification of these complex devices require specialized expertise, driving the market for testing and certification services. For instance, in October 2019, TÜV SÜD signed an MoU with the NUS Centre for Additive Manufacturing, in order to promote research and development activities related to 3D-printed biomedical implants.

Patient safety is a top priority in the healthcare industry. Ensuring the safety and reliability of medical devices through rigorous testing and certification processes reduces the risk of adverse events and enhances patient outcomes. The increasing emphasis on patient safety fuels the demand for testing and certification services. This is estimated to enhance the growth of the global medical device testing and certification market.

The growing global healthcare infrastructure, particularly in emerging economies, has led to increased production and adoption of medical devices. This expansion in the market creates a need for comprehensive testing and certification services to meet regulatory requirements and gain market access.

Covid-19 Impact Analysis:

The COVID-19 pandemic heightened the importance of reliable and safe medical devices. The demand for testing and certification services increased significantly, particularly for COVID-19 diagnostic tests, ventilators, and personal protective equipment (PPE). The need for rapid certifications and approvals to meet the urgent healthcare demands positively impacted the global medical device testing and certification market. For instance, in June 2020, Intertek expanded the personal protective equipment services, in order to include pre-certification testing of N95 respirators, abiding by the requirements made by the National Institute for Occupational Safety and Health (NIOSH).

Key Takeaways:

·         North America is expected to dominate the growth of the global medical device testing and certification market. The region has well-established regulatory frameworks, a strong healthcare infrastructure, and a high number of medical device manufacturers. Strict regulatory compliance requirements contribute to the market growth in this region. For instance, according to the Ontario Hospital Association, in 2021, there were around 390 hospitals in Ontario, Canada.

·         Europe is estimated to witness high growth in the global medical device testing and certification market. The region has stringent regulations, such as the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), which drive the demand for testing and certification services. For instance, in January 2022, DNV acquired MEDCERT, in order to expand the company's medical device assurance footprint.