All Post-market surveillance (PMS) articles
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ContentsRegulatory Rapporteur June 2026 – Contents
The June issue of Regulatory Rapporteur focuses on lifecycle management.
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EditorialLifecycle management: Enhancing regulatory agility
Navigating complex regulatory requirements across multiple regions and dealing with fragmented data are common challenges for keeping marketing authorisations and technical files compliant. This June issue of Regulatory Rapporteur looks at how AI and advanced digital technologies can help by integrating data and generating predictive insights, enabling more proactive lifecycle management and time for innovation.
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JournalEnhancing post-market surveillance with Artificial Intelligence and predictive analytics
Fragmented data and manual review can limit the impact of PMS. Find out more about how AI, can modernise PMS workflows to improve early issue detection and support corrective actions, using a 20-year analysis of arthroscopic-device recalls to illustrate predictive analytics in practice.
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ContentsRegulatory Rapporteur April 2026 – Contents
The April issue of Regulatory Rapporteur focuses on access to medicines.
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EditorialAccess to medicines: From approval to
patient-centred deliveryThis issue focuses on access to medicines, and demonstrates how lifecycle regulation, diverse evidence, operational innovation and corss-sector collaboration all contribute to improving the timely, equitable and trusted delivery of medicines.
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JournalLean Six Sigma in post-market surveillance: Insights for EU 2017/745 MDR Article 88 and Great Britain SI 2024/1368 (44ZN) trend reporting compliance
This article demonstrates how Lean Six Sigma principles can strengthen post-market surveillance systems for medical devices, enabling manufacturers to detect statistically significant trends in non-serious incidents and meet evolving EU MDR Article 88 and UK SI 2024/1368 44ZN requirements through structured DMAIC methodology and statistical process control
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JournalEmergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
This article explores the FDA’s Emergency Use Authorisation framework and its aim to speed up the deployment of IVDs during public health emergencies, focusing on its evolution, operational mechanisms and significance in public health preparedness.
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JournalMD8: Post-market challenges for medical devices
This is a report of the MD8 session that took place at this year’s Symposium.
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JournalMD4/IVD4: Bridging the gaps – Developments in medical device and IVD regulatory harmonisation
This is a report of the MD4/IVD4 session that took place at this year’s Symposium.
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Industry newsUpdated post-market surveillance requirements take effect
This industry news update looks at the MHRA’s new PMS requirements for medical devices that took effect on 16 June 2025.
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JournalArtificial intelligence and post-market surveillance
Artificial intelligence (AI) is a force that is both feared and revered for promising revolutionary improvements in many fields. While tools like ChatGPT may create an impression of AI being easy to use, such wide AI applications are prone to hallucinations, or misleading information, and therefore can be dangerous in the context of post-market surveillance (PMS). The more accurate narrow AI tools for PMS do not yet exist, but hold a lot of promise for the future. The solution for effective PMS by AI will require restructuring data into appropriate formats for machine learning (ML).
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JournalThe EU Medical Device Regulation: Balancing innovation with regulation
The EU Medical Device Regulation (EU MDR) 2017/745 was introduced in response to the need for tighter regulation of medical devices (MDs) in Europe. However, with the increased regulatory burden, there could be potentially hundreds of unanticipated ramifications, particularly for smaller manufacturers and start-ups. By increasing regulation so significantly in a relatively short time period, the very rules which are designed to protect patients may prevent them from accessing the treatment they need and stifle innovation, as start-ups inevitably struggle under the weight of new requirements. This article assesses the delicate balance between innovation and regulation and analyses the relationship between the two.
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Industry newsMHRA issues guidance on post-market surveillance regulation in Great Britain
The Medicines and Healthcare products Regulatory Agency (MHRA) has published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation
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Industry newsGreater post-market surveillance for medical devices
New draft legislation was laid before the UK Parliament on 21 October 2024 which would require greater post-market surveillance (PMS) for medical devices on the market in Great Britain.
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JournalImpact of clinical data requirements following EU MDR (2017/745) & Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)
The EU Medical Device Regulation 2017/745 (EU MDR) and guidance on clinical evaluation (MEDDEV 2.7.1 Rev 4) have replaced the previous regulations governing the placing of medical devices on the European market. Concerning that these new requirements may be difficult to implement and pose an additional burden to Medical ...