MEDICAL TECHNOLOGY
require rigorous oversight from a Notified Body, a sharp reversal from the previous self-certification model. Conversely, the US FDA maintains
a three-tier system (Class I, II, and III) that often places high-tech diagnostics like next-generation sequencing based oncology tests in Class II with ‘special controls’ or Class III requiring Premarket Approval (PMA). This creates a scenario where a single product may require a PMA in the US but a Class C + EMA consultation in the EU, forcing businesses to synchronise divergent technical files, scientific validity reports, and clinical performance data to meet the stricter, non-grandfathered IVDR transition deadlines ranging from 2027 to 2029.
7. Cybersecurity and post-market surveillance requirements Under updated mandates from the FDA, the EU’s MDR, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), pre-market submissions are no longer considered complete without comprehensive cybersecurity documentation, most notably a Software Bill of Materials (SBOM). An SBOM acts as a transparent ‘ingredients list’ of all third-party and open-source software components, allowing both regulators and healthcare providers to quickly identify vulnerabilities when new threats emerge.
8. Convergence on GMLP and harmonisation efforts
International bodies like the International Medical Device Regulators Forum (IMDRF), in collaboration with the FDA, MHRA, and Health Canada, have established 10 Guiding Principles for good machine learning practice (GMLP). These principles serve as a global blueprint for ensuring that AI/ML-enabled medical devices are safe, effective, and ethically developed throughout their total product life cycle. Regulators now expect these principles to be integral to quality management
Continuous, real-world monitoring is now the cornerstone of EU device regulation
systems and technical documentation adding a new level of scrutiny.
9. Emerging device classes Regulators are clarifying pathways for: Digital therapeutics / prescription software with the creation of ‘prescription-only’ software categories that require clinical evidence of a therapeutic effect, often utilising fast- track reimbursement pathways Combination products (drug + device + software) with more coordinated reviews that allow for unified quality management systems, reducing redundant filings when only the software component is updated 3D-printed personalised devices and biologic/device hybrids, validating the underlying design parameters and manufacturing processes, allowing for safe, point-of-care customisation, instead of certifying every unique patient implant.
Regulators are overhauling these pathways because the traditional model of regulation is fundamentally incompatible with the way modern medical technology functions.
10. Supply-chain resilience, environmental rules and equity
Regulators and policymakers are paying more atention to the transparency of their supply chain, focusing on traceability and Unique Device Identification (UDI) enforcement. Environmental sustainability requirements and equity based on real-world performance across diverse populations are also broadening the scope of concern.
The mandatory activation of EUDAMED
(European Database on Medical Devices) modules in May 2026 has in fact turned UDIs into a real-time traceability requirement, while the EU’s Packaging and Packaging Waste Regulation (PPWR), applying from August 2026, forces a redesign of medical packaging to meet strict recyclability and weight- minimisation standards. At the same time health equity has
become non-negotiable; under the FDA’s 2025 Diversity Action Plan mandates, and the UK’s 2026 clinical trial reforms, manufacturers must now provide ‘Diversity Action Plans’ and real-world performance data to prove that their devices function with equal precision across diverse racial, ethnic, and age- based populations. This is key to protecting users from dangerous bias when devices leverage AI in their design.
Jonathan Ripley is Managing Director of IMed Consultancy a medical devices consultancy firm. An expert in quality management and regulatory affairs with a robust background spanning over a decade in the IVD and medical device industries, Jonathan holds a degree in microbiology from King’s College. Specialising in GxP systems, Jonathan has managed ISO 13485:2016 and ISO 9001:2015 QMS certified systems. His regulatory expertise encompasses RT-PCR, immunoassays, and immunochromatographic technologies, as well as developing manufacturing capabilities and guiding clients through global regulatory landscapes, including the UK, EU, and US markets.
www.imedconsultancy.com
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