Medical Device Testing Market Size, Share, Growth, and Industry Analysis, By Type (Inspection, Services, Testing Services, Certification Services, Others) By Application (Active Implant IVD, Orthopedic & Dental, Ophthalmic, Vascular, Others) and Regional Insights and Forecast to 2034

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MEDICAL DEVICE TESTING MARKET OVERVIEW

The global medical device testing market size was USD 11.55 billion in 2025 and is projected to reach USD 17.26 billion in 2034, exhibiting a CAGR of 4.33% during the forecast period 2025–2034.

The market includes a wide range of laboratory and field studies ensuring the safety, performance, and regulatory compliance of a device throughout its lifecycle within which the medical device testing market verifies design verification; biocompatibility and toxicology; EMC/electrical safety and sterilization validation; software and AI/ML verification; packaging/transport simulation; and post-market surveillance. The driving force of demand is strict frameworks, including EU MDR/IVDR, US FDA requirements (QMSR, 21 CFR), ISO 13485/14971/10993 series, IEC 60601/62304/62366, and country scheme and, on the whole, increase the level of evidence and documentation requirements. Contracting out to dedicated third-party labs reduces time-to-approval, global-market de-risking and access to accredited facilities, Notified Bodies, and specialist expertise (e.g., chemical characterisation and human factors, cybersecurity and AI validation). The market is fragmented in terms of the categories of the devices (active implantables, diagnostics, dental/orthopedic, ophthalmic, vascular, digital therapeutics) and types of end-clients (such as OEMs, start-ups, C(D)MOs). Examples of growth tailwinds miniaturization, connected/IoMT devices, combination products, and enhanced attention on material/sterilization (EtO, steam, gamma, e-beam). Major international suppliers a mix of TIC companies, as well as highly specialized laboratories, is increasing capacity, web-based portals, and integrated quality systems to accommodate multi-site programs and international filings. As equipment becomes increasingly software-defined and data-driven, test programs now include cybersecurity, interoperability, real-world performance/AI bias/robustness test and validation which make the industry a key enabler to new innovations and market entry. Examples of sizing the market, and recent expansions (Intertek, TUV Sud, SGS, Eurofins).

COVID-19 IMPACT

Medical Device Testing Market Had a Negative Effect Due to Supply Chain Disruption During COVID-19 Pandemic

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

Whereas COVID-19 eventually spurred demand of diagnostics and some essential equipment, the short-term shock restrained the medical device testing market share. Validations and clinical trials have been slowed; travel bans delayed on-site audits, usability testing, and factory inspections; supply chain disruptions impact availability of samples and component qualification; and capacity limits and biosafety requirements in many labs have lengthened turnaround times. OEMs re-prioritized portfolios to pandemic-related products, and postponed elective-care devices, which, in some product areas (e.g., orthopedic/ophthalmic) resulted in lower testing volumes. Regulatory bodies provided emergency flexibilities, however there were bottlenecks with routine conformity assessment and MDR/IVDR transitions, particularly with a constrained availability of Notified Bodies. The net outcome was schedule slippage, spiraling costs and a build-up in the backlog. When things returned to normal, pent-up submission and higher regulatory demands caused an overshoot; providers ramped remote audit, digital portal, and lab network capacities to address backlogs and build resiliency, the pandemic highlighted how varied geographic presence, the use of digital records, and redundancy of core assays (e.g. biocompatibility, sterilization validation) remain critical factors to maintain operations. Recovery recovery industry communications and expansions: SGS, TUV, Intertek, Eurofins).

LATEST TRENDS

Rise of Regenerative and Traceable Merino Wool Drives Market Growth

One of the most characteristic trends is the quick transformation toward software-based devices and SaMD that is changing the range of verification/validation. Test houses are incorporating IEC 62304 life-cycle verification, AI/ML model verification & robustness checks, data integrity, and human-factors into bundled programs with conventional electrical safety (IEC 60601) and EMC. Cybersecurity now requires threat modeling, secure development life-cycles, SBOM, vulnerability scanning and penetration testing and post-market monitoring. Parallel to this, sterilization sustainability and specific chemistry-oriented inspection (ISO 10993-18/-17) are increasing e.g., increased small-scale EtO capacity to mitigate risks against residuals and continuity of supply. Global TIC providers are meeting this with greater Notified Body scopes, scale-up capabilities, and cross-discipline initiatives integrating chemistry, software and systems engineering to speed MDR/FDA submissions. This trend has had the effect of condensing timelines via so-called one-stop pathways to complex and connected devices as they cross geographies. What are typical stories (examples: Intertek MDR Scope expansion; Eurofins EtO sterile solution; TUV SUD facility/network investments).

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MEDICAL DEVICE TESTING MARKET SEGMENTATION

By Type

Based on type, the global market can be categorized into Inspection, Services, Testing Services, Certification Services, Others Active Implant

• Inspection Services: Factory and warehouse inspections including physical/visual examination, sampling, and in-process inspection; Workmanship, labeling and measures of packaging integrity/Intact pre-shipment.

• Testing Services: Laboratory tests: biocompatibility & chemical profiling (ISO 10993), electrical safety/EMC, software testing, packaging/ transport, sterilization verification, bench/ functional.

• Certification Services: Enabling third-party conformity assessments Third-party conformity assessments (e.g., EU MDR/IVDR Notified Body, ISO 13485 certification, CE/UKCA marking, CB scheme) that allow access to the market.

• Others: Supplier/QMS audits, training, technical documentation, vigilance/PMCF, cybersecurity assessment and digital submission/quality portal solutions.

By Application

Based on Application, the global market can be categorized into IVD, Orthopedic & Dental, Ophthalmic, Vascular, Others

• Active Implant: Pacemakers, neurostimulators, pumps--needs electrical safety, EMC, longevity of battery, hermetic or vacuum sealing, and stringent evidence of biocompatibility/ sterilization.

• IVD: Diagnostics/reagents/instruments/software- analytical/performance studies, software validation, and usability in accordance with the IVDR/FDA CLSI guidance.

• Orthopedic & Dental: Implants/instruments- mechanical fatigue, wear/debris, materials/chemistry, sterilization validation, and packaging simulation.

• Ophthalmic: Lenses/implants/instruments-ocular biocompatibility, optical specification, cleaning/sterility, and human-factors to handle/utilize safely.

• Vascular: Methanol, Chitosan, SD-30, VA-HCA-6, HCA-5, AND HYPERSIL International Trial Group QUEST, Hemodynamics, Fatigue, Coating Integrity, Sterility/pyrogen, Packaging Strength, and Clinical performance- Planning.

• Others: Wound care, patient monitors, software apps, combination products- specific test batteries that encompass usability, cybersecurity, EMC, and chemistry.

MARKET DYNAMICS

Driving Factors

Regulatory escalation & multi-market access pressure Boost the Market

EU MDR/IVDR, increased quality alignment requirements between FDA and ISO 13485, and stricter expectations on risk, usability, software, and chemistry evidence have increased the bar materially to submissions. Manufacturers are now required to illustrate compliance both with regulatory standards, including IEC 60601 (electrical safety/EMC), IEC 62304 (software lifecycle), IEC 62366 (human factors), and ISO 10993-17/-18 (toxicology/chemical characterization), and with quality initiatives, frequently multiple geographies at a time. The complexity will be driving OEMs, particularly startups and SMEs, to outsource to accredited third-party labs and Notified Bodies capable of issuing global recognized reports and certifications, shortening time-to-approval and de-risking audits. This has been pulled with recent scope expansions and infrastructure investments made by the key players in the TIC industry.

Device complexity: software, connectivity & materials Expand the Market

The shift to connected, software-enabled devices (including SaMD) and novel polymers, coatings, and batteries increases the number of points that must be verified, manyfold, with cybersecurity threat modeling verification requirements, SBOMs and interoperability evaluation, bench/functional stress, and extractables/leachable. Test partners have reacted to create SaMD/health-software certification testing, IEC 60601 programmers and chemistry/sterilization capability. This more fundamental test grid generates long-term demand in bundled programs that integrate electrical safety, software robustness, biocompatibility, packaging/transport, and sterilization validation--ideally within a single facility to obviate delays

Restraining Factor

Capacity bottlenecks & Notified Body Scarcity Potentially Impede Market Growth

The EU MDR/IVDR increased the standards of technical documentation, clinical/performance evidence, and post market vigilance. Slow as it is being improved, reviewer availability at an Notified Body and dedicated lab time ( e.g., sterilization, chemistry/biocompatibility ) at specialized labs are stretched, with lead times and budgets taking a hit, particularly in a small to medium enterprise ( SME ). Prominent providers have invested in alleviating the crunch (facility modernizations, digitalization and added scopes), however, the demand wave continues to outrun throughput, causing bottlenecks to more complex and multi-discipline files. OEMs will have to book slots earlier, synchronize the procedures to prevent retests and get partners who release more transparent schedules and who can run the end-to-end.

Sterilization modernization & advanced chemistry Create Opportunity for The Product in The Market

Opportunity

Increased monitoring of ethylene oxide (EtO) emissions / residuals and heightened ISO 10993-17 / -18 expectations, are propelling the demand of pilot-scale EtO, rapid residuals testing requirements, toxicology risk assessments, and such integrated sterile-packaging initiatives. Vendors that can match sizes of small-batch EtO equipment and manufacturing chemistry are winning change-controls, re-validations, and new product approvals, accelerating time-to-release and reducing risk to supply.

Newer deployments are the US shop small-volume EtO solution by Eurofins and larger sterile-packaging/sterilization regimes, whereas SGS added MDR sterilization capacity recognized by the FAMHP Belgium, broadening the number of reviewers to which OEMs can appeal.

Cybersecurity & SaMD validation at scale Could Be a Potential Challenge for Consumers

Challenge

In addition to software lifecycle evidence under IEC 62304, regulators and hospitals have increased expectations of SBOMs, vulnerability management, secure development lifecycle evidence, and post-market surveillance of the connected devices.

AI/ML robustness and standardised, repeatable continuous training often remain experimental, repeatedly delaying portfolios. According to leading TIC companies and Notified Bodies, software-aware program training and digital portals are in their sights, yet aligning jurisdictions (EU MDR/IVDR vs. US) and testing depth relative to clinical risks continue to shift the goal posts necessitating OEMs to engage in the harmonization process.

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MEDICAL DEVICE TESTING MARKET REGIONAL INSIGHTS

• North America

North America holds a major medical device testing market share. The dense ecosystem of startups, med-tech scale-ups, and large OEMs that drive high turnover in the North American market of software-defined and connected medical devices with cybersecurity and human-factor, EMC/electrical, and biocompatibility testing requirements anchor its medical device testing demand. US-based centers of excellence are extending biologics/chemistry and sterility services to combination products and devices with biological interfaces that allow end-to-end programs that feed FDA filing and world filings. Testing requirements to be sourced near production centers in the North America supply chains, with nearshoring and Mexico, cuts logistics and turnaround. Big suppliers have ventured into investing back in United States medical device testing market’s manufacturing and instrumentation so as to alleviate bottlenecks and increase the rate of releasing devices.

Europe

The trend in conformity assessment under EU MDR/IVDR continues to be centered in Europe, hence the enduring demand on Notified Body review, clinical/performance, and elaborate chemical/sterilization analysis. Capacity and scope development of TICs and Notified Bodies in the MDR/IVDR space has been motivated by the need to manage more complex dossiers and digitalization in this environment, but reviewer availability continues to influence CE marking timelines. Testing priorities and investment cadence in the region will remain impacted by policymaking activity and recent MDCG guidance (and Parliament discussions on MDR/IVDR revision).

Asia

Asia is characterized by huge manufacturing scale, the rise of domestic regulatory activity and the increase in the volume of submissions locally. Global suppliers are broadening APAC footprints to allow OEMs to generate accredited EMC, biocompatibility, packaging, and sterilization data nearer production, and then ladder the output into EU/US dossiers, to save transportation time, cost, and sample-handling risk. Asian countries are developing analytical and bioanalytical capability with China, India, South Korea, and Southeast Asia becoming progressively important as sources of production testing and as regional market access enablers.

KEY INDUSTRY PLAYERS

Key Industry Players Shaping the Market Through Innovation and Market Expansion

The market combines international TIC giants and high-end laboratories: Intertek (recently increased its EU MDR Notified Body scope to cover wider device range and accelerated CE routes), SGS (globally-networked labs with significant biopharma/biologics and sterilization capacity enhancements in the U.S. and EU), TUV Sued (electrical safety/EMC, chemistry and Notified Body services backed by strategic investment and digitalization activities), Eurofins Medical Device Services (biocompatibility, extractables & leachables, and new small These companies are transitioning single-line testing to blended, multi-discipline platforms that integrate chemistry/toxicology, sterilization science, software/AI validation, cybersecurity, packaging/transport and human factors - often regional centers of excellence and digital portals to shorten multi-market submission and change of lifecycle. Their new investments and the expansion of scope are direct responses to MDR/IVDR pressures and OEM demand one-stop, accredited test-and-certification solutions.

List Of Top Medical Device Testing Companies

• TUV SUD (Germany)
• Dekra (Germany)
• Intertek (U.K.)
• TUV Rheinland (Germany)

KEY INDUSTRY DEVELOPMENT

2025-07: Intertek Expanded EU MDR Notified Body scope to broaden device coverage and support CE marking.

REPORT COVERAGE

The medical device testing market is emerging as a strategic, lifecycle-driven ecosystem, which extends well beyond a one-time compliance testing approach. Increased regulatory expectations (especially EU MDR/IVDR, and the current FDA en-ISO convergence) and the alacritous adoption of software-controlled, connected, and combination products are increasing remit on testing, into cybersecurity and AI/ML robustness, extractables/ leachables, sterilization sustainability, human factors, and continuous post-market surveillance. This complexity is driving OEMs to accredited, geographically dispersed partners able to offer integrated programs (ie, chemistry/toxicology, sterility, EMC/electrical, software validation, and certification) under the same contractual umbrella to minimize the retesting and time risk associated with multiple contracts. The market leaders are countering with strategic investments: increasing MDR Notified Body offerings, offering small-batch EtO and sterilization, build-outs of biologics/chemistry footprints (including in the US) and offering digital portals and harmonized multi-site processes to handle dossier complexities. The software and biointerface testing are area-driven by the innovation density in North America, MDR regime in Europe supporting significant conformity demand and Asia, with its scale of manufacturers and relatively increasing number of accredited laboratories, meeting a majority of filings cost-effectively in close geographic proximity. Short term frictions exist, such as Notified Body capacity, aligning cybersecurity/AI expectations, and harmonizing cross-jurisdictionally-aligned evidence, as well as opportunities to providers capable of standardizing, scaling, and digitalizing tests across disciplines. In general, the industry will be on a stable super-GDP trajectory as device suppliers and regulatory bodies move towards more rigorous, seamless assurance systems that can provide safer, faster patient access across geographies.