A US quality rule aligned with ISO 13485 took effect on 2 February 2026.
Why this market is moving now
- The US quality rule for devices now incorporates ISO 13485 and took effect on 2 February 2026.
- The EU proposed a targeted simplification of its device rules on 16 December 2025.
- EU transition periods for legacy devices end on 31 December 2027 or 31 December 2028, depending on risk class.
- Europe's share of the world device market fell to 25.6% in 2025 from 26.4% a year earlier.
Key figures
Global figures for this market, with the year each one describes. Use Cite to copy a reference to this page.
| Figure | Value | Year | Cite |
|---|---|---|---|
| 31,215 ISO 13485:2016 medical device quality management certificates were valid worldwide at the end of 2024, covering 43,957 sites. | 31,215 certificates | 2024 | |
| The United States was the largest medical device market in 2025, with 47.6% of the world market at manufacturer prices. | 47.6 % of world market | 2025 | |
| Europe held 25.6% of the world medical device market in 2025, down from 26.4% a year earlier and close to 29% in 2015. | 25.6 % of world market | 2025 | |
| China held 5.4% of the world medical device market in 2025 at manufacturer prices. | 5.4 % of world market | 2025 | |
| Japan held 4.6% of the world medical device market in 2025 at manufacturer prices. | 4.6 % of world market | 2025 | |
| The US device quality rule that adopts the ISO 13485 standard by reference, to align with other regulators, took effect on 2 February 2026. | 2 February 2026 | 2026 | |
| Legacy devices can stay on the EU market until 31 December 2027 or 31 December 2028, depending on risk class, if set conditions are met. | 31 December 2027 | 2027 | |
| On 16 December 2025 the EU proposed a targeted simplification of its medical device rules. | 16 December 2025 | 2025 | |
| The EU Medical Device Regulation (EU) 2017/745 has applied to devices sold in the EU since 26 May 2021. | 26 May 2021 | 2021 |
Calculated figures (shares, changes and prices per kilogram) are plain arithmetic on the reported values. Read how we work.
What the full report covers
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the global market - 03Global market size, 2021 to 2025
Historical series and growth rates - 04Countries and regions
Demand, supply and trade by country and region - 05Outlook to 2031
Base, low and high scenarios with stated assumptions - 06Rules, policy and deadlines
Regulation and programmes that change demand - 07Drivers and barriers
What accelerates or slows adoption, by customer segment - 08Prices, costs and margins
Unit economics where public data allows - 09Competitive landscape
8 to 12 company profiles with recent moves - 10Opportunities and risks
For new entrants, suppliers and investors - 11Method and assumptions
How every figure was built
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Frequently asked questions
How big is the global medical device regulatory compliance market?
One measure is certification. At the end of 2024, 31,215 ISO 13485 quality management certificates were valid worldwide, covering 43,957 sites.
Which countries are the largest medical device markets?
In 2025 the United States held 47.6% of the world medical device market and Europe 25.6%. China held 5.4% and Japan 4.6%.
When did the US QMSR take effect?
The US device quality rule that adopts ISO 13485 by reference took effect on 2 February 2026.
What are the EU MDR deadlines?
The EU Medical Device Regulation has applied since 26 May 2021. Legacy devices can stay on the market until 31 December 2027 or 31 December 2028, depending on risk class, if conditions are met.
Is the EU changing its medical device rules?
Yes. On 16 December 2025 the EU proposed a targeted simplification of its medical device rules.
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