MEDICAL TECHNOLOGY
divergent international frameworks and phased implementations of major legislation. While the US focuses on its SaMD Action Plan and the UK utilises the MHRA’s Change Programme Roadmap, the EU is navigating the phased rollout of the AI Act (effective August 2024) and the Data Act (effective September 2025). These regional differences in classification and evidence requirements create significant risks for businesses, as inconsistent pathways can lead to inflated development costs or delayed market entry.
2. EU regulatory deadlines: MDR and IVDR transitions
The EU continues its rigorous enforcement of the Medical Device Regulation (MDR) alongside extended In Vitro Diagnostic Regulation (IVDR) legacy timelines, creating a complex compliance environment for manufacturers. With phased legacy transitions and class-specific deadlines, companies must carefully track their conformity assessment requirements and leverage transitional provisions strategically. Missing these staggered timelines could result in products losing market access, making proactive regulatory planning essential for maintaining EU market presence. On top of this, the European
Commission’s December 2025 reform proposal is built around three themes that will define EU compliance for years ahead: lifecycle surveillance oversight, post- market data as a core instrument and proportionate regulation based on risk. These changes signal an EU environment that is simultaneously more demanding on post-market surveillance and more targeted in how that demand is applied.
3. UK regulatory overhaul and UKCA timelines In the UK, the MHRA currently accepts CE-marked devices on the Great Britain market until 30 June 2030 and, on 16 February 2026, launched a formal consultation on making that recognition indefinite. The proposals, which would remove the need for duplicate certifications, would establish a clear goal to maintain device availability in Great
The UK’s MHRA recently launched a formal consultation on making the recognition of CE-marked devices on the Great Britain market indefinite.
Britain whilst responding to the industry’s consistent call for long-term regulatory certainty. The UKCA mark is being repositioned as a specialist route for first- in-market and innovative technologies, including AI-enabled devices, rather than a universal requirement. The outcome of this consultation is poised to shape the statutory framework for device market access in the UK for the foreseeable future.
4. US FDA: digital health, SaMD and cybersecurity expectations tighten
The FDA is formalising expectations for AI-enabled devices, SaMD, cybersecurity design and post-market practices. This overhaul officially aligns US quality standards with ISO 13485:2016, requiring manufacturers to embed risk management and cybersecurity into their core organisational fabric rather than treating them as standalone technical hurdles. In February 2026, the FDA also finalised critical guidance on Cybersecurity in Medical Devices, mandating that premarket submissions include a detailed Software Bill of Materials (SBOM), threat models, and
proactive patch management plans to address vulnerabilities throughout the device’s operational life.
5. China (NMPA): updated GMPs and national standards
On 4 November 2025, the National Medical Products Administration (NMPA) released a fully revised Good Manufacturing Practice (GMP) for medical devices, the first major update since 2014. This new framework, which becomes mandatory on 1 November 2026, represents a paradigm shift toward lifecycle risk management. It introduces three entirely new chapters on: Quality Assurance, Validation and Verification, and Contract Manufacturing/ Outsourcing that mirror international shifts towards continuous compliance. For manufacturers, this means that
registrations will no longer be treated as static events and NMPA inspections will now evaluate how GMP principles are integrated into daily operational data and real-time risk controls. Manufacturers will need to align technical files, invest in local testing and understand testing expectations, requiring China-specialist compliance resources.
The EU continues its rigorous enforcement
of the MDR alongside extended IVDR legacy timelines, creating a complex compliance environment for manufacturers
6. IVDs and point-of-care testing under new scrutiny While the US and EU both utilise risk- based frameworks for in vitro diagnostics (IVDs), their classification tiers and evidence expectations significantly diverge, creating a ‘multi-lane’ compliance challenge for global manufacturers. In the EU, the IVDR (2017/746) categorises devices into four tiers (Class A to Class D) where approximately 80% of all diagnostics
June 2026
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