The year 2026 brings major shifts in the ecosystem of high-risk medical devices across the European Union. Manufacturers, investors, and CROs must prepare for a much more complex regulatory landscape, shaped by two key developments: the extended MDR transition and the enforcement of the AI Act for high-risk artificial intelligence systems.
1. MDR – A critical deadline for certain high-risk devices
For specific categories (e.g., custom-made Class III devices), 26 May 2026 remains an important milestone in the transition to Regulation (EU) 2017/745 (MDR).
Manufacturers must finalise their technical documentation, conformity assessment, and post-market surveillance strategy to maintain market access in the EU.
For the medtech sector, 2026 marks a moment of “selection”: only companies with robust regulatory processes will keep their portfolios active.
2. The impact of the AI Act – Enforcement for high-risk AI systems
Starting 2 August 2026, many medical devices integrating artificial intelligence will fall under the definition of high-risk AI systems.
This brings additional requirements related to:
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data governance,
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transparency and explainability,
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continuous monitoring,
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algorithmic risk management,
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technical documentation aligned with both MDR and the AI Act.
For smart devices and digital health platforms, dual compliance will become the new standard.
3. What 2026 means for manufacturers, investors, and CROs
The industry will undergo a period of reassessment and reinvestment in quality.
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Manufacturers will need to strengthen regulatory teams, upgrade quality systems, and prepare for more rigorous audits.
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Investors will increasingly favour companies with solid compliance strategies.
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CROs, such as Tigermed EMEA, will play a crucial role in helping companies navigate these new demands.
4. How Tigermed EMEA supports medical device manufacturers in 2026
At Tigermed EMEA, we support medtech innovators through:
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MDR consultancy and documentation preparation,
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design & management of clinical studies for high-risk devices,
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trials for devices with digital and AI components,
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integration of AI Act requirements into research programs,
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post-market surveillance and real-world evidence generation.
Our global expertise combined with strong local capability in Eastern Europe provides a reliable framework for launching or maintaining medical devices on the EU market.
2026 is the year when compliance becomes a competitive advantage.
Tigermed EMEA is the partner that transforms regulatory complexity into real progress.
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