The withdrawal of Bayer’s Essure permanent contraceptive device from global markets and the recall of DePuy’s ASR metal-on-metal hip system are among the high-profile safety failures that have spurred regulators to strengthen post-market surveillance (PMS) frameworks. Steadily, medical device monitoring is being brought considerably closer to the long-established rigor of pharmaceutical safety surveillance. Yet its make-up remains fundamentally different.
This difference matters considerably for manufacturers of combination products — GLP-1 auto-injectors, ocular implants, “connected” drug delivery systems and app-enabled therapies — because these products feature both a drug component and a device component. As regulatory requirements intensify, and as the data held in device safety databases starts to be actively analysed by the authorities themselves, anyone developing and marketing a device-based offering will be required not merely to collect associated safety data, but to make sense of it — in context.
Evolving Regulatory Frameworks
In December 2025, the EU’s Medical Device Coordination Group (MDCG) published MDCG 2025-10, its most detailed guidance to date on PMS under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The guidance makes clear that passive complaint handling is no longer an adequate approach to device safety monitoring. Manufacturers will also be expected to apply systematic, documented and reproducible methods to analyse post-market data — looking not just at individual incidents, but also at cumulative trends.
Those findings must be routinely described to regulators within device PMS plans and Periodic Safety Update Reports (PSURs), and be inspection-ready. Crucially, companies are expected to use analytical outcomes actively within risk management and benefit-risk reassessments — establishing device safety surveillance as an ongoing analytical discipline, not a reporting exercise.
Linked MDCG draft guidance on trend reporting adds further specificity. Article 88 of the MDR has always contained a trending obligation; the forthcoming guidance removes ambiguity about what compliance actually requires, specifically mandating the definition of measurable statistical thresholds and observation periods within PMS plans.
In the UK, revised Medical Devices (Post-Market Surveillance Requirements) regulations came into force in June 2025, introducing explicit PMS and vigilance obligations for Great Britain — including shorter serious incident reporting timelines and enhanced real-world data collection requirements. The MHRA has framed these changes explicitly in terms of enabling faster regulatory response when safety issues emerge — language that implies active surveillance, not just passive receipt of information.
In the US, the Quality Management System Regulation (QMSR), which aligns FDA requirements with ISO 13485, has reinforced the same expectation of integrated, lifecycle-spanning device safety monitoring as a core quality obligation. Across all three regulatory jurisdictions, the clear direction of travel is from data submission to data interrogation.
Asia-Pacific jurisdictions are moving in the same direction. In July 2024, China’s National Medical Products Administration (NMPA) issued a draft national standard on post-market surveillance for medical device manufacturers — modelled closely on ISO/TR 20416:2020 — that explicitly requires manufacturers to establish comprehensive systems for collecting, analysing, and interpreting device performance data, including the submission of PSURs and the continuous updating of risk management files throughout the device lifecycle. A further NMPA announcement in October 2025 signaled the authority’s intent to expand the use of real-world evidence in regulatory decision-making for high-end and innovative medical devices. Japan’s PMDA, meanwhile, already applies datamining tools to post-market safety signals through its MIHARI pharmacoepidemio-logical research project — an indication that analytical post-market surveillance is not a future aspiration in this region, but an established regulatory expectation. For manufacturers supplying device or combination products across Asia-Pacific markets, the convergence of expectations with those of the EU and US regulators is notable.
The Combination Product Problem
Combination products present a surveillance challenge that goes beyond the sum of those products’ parts. This is because a safety issue could originate in the medicinal component, in the device element, in the interaction between the two, or even in the instructions for use. These are not cleanly separable phenomena; therefore, they cannot be adequately monitored by systems designed to handle only one.
In many organisations, drug safety surveillance and device-related complaint management have historically been run as separate processes by separate teams, using separate systems. That separation is now untenable. As requirements converge and as databases on both sides begin to be actively mined for signals, organisations that operate disconnected systems face a specific risk: namely that safety signals existing in the relationship between drug and device data may not be visible.
The statistical challenge compounds the situation. Disproportionality analysis — the foundation of much drug safety signal detection — depends on large accumulated datasets. Even a national regulator’s entire device incident database may contain only hundreds of thousands of cases. Device surveillance therefore requires statistical approaches capable of detecting meaningful changes at lower data volumes, and that normalise findings against exposure levels rather than relying on raw case counts. Since many device approvals rest on demonstrated equivalence to similar products, manufacturers also have an obligation to monitor relevant class-level data beyond their own.
Where Current Approaches Fall Short
Many companies have approached evolving device surveillance requirements by augmenting existing product complaint platforms — e.g. TrackWise or Veeva Vault — to capture the structured data fields required under MDR/IVDR. These systems were not designed for statistical analysis, however. As a result, once data has been captured, teams typically export it into spreadsheets or statistical packages external to the core safety infrastructure, for manual review.
This workaround may have sufficed when regulators were primarily concerned with whether data was being submitted at all, but it is unlikely to remain defensible as scrutiny matures. The MHRA, for example, has already begun conducting active signal detection on device data submitted through its Yellow Card scheme. As those analytical capabilities develop, manufacturers can expect to receive specific regulatory queries about patterns in their data — and will need to demonstrate not only that they submitted the data, but that they are routinely reviewing and interrogating it themselves, with an auditable record of that activity.
Building a More Coherent Surveillance Strategy
The case for a unified analytical approach to drug and device surveillance is both regulatory and operational. For combination product manufacturers, analysing drug and device data within the same framework creates the possibility of identifying and linking safety signals that cross the drug-device boundary. It enables clearer attribution, distinguishing issues that originate in the medicinal component, those rooted in a device element, and those that may reflect an interaction between the two. It also allows safety topics to be managed within a single governance structure — with traceable relationships between related signals — rather than duplicated or fragmented across parallel systems.
Granularity is paramount. A combination product is rarely a single entity. An ocular implant product may incorporate an active medicinal substance alongside several distinct physical elements, each of which can be associated with safety data using component-level identifiers such as the Global Medical Device Nomenclature (GMDN) code or the Unique Device Identifier (UDI). That specificity becomes particularly valuable when a safety concern emerges in a component shared across multiple products in a portfolio, enabling rapid assessment of scope and a proportionate response.
For organisations currently operating separate surveillance systems, the optimal path forward is likely to involve integration of current capabilities rather than replacement. Companies with mature pharmacovigilance infrastructure are well placed to extend that capability to encompass device surveillance. Those approaching structured device surveillance for the first time, on the other hand (whether from a pharmaceutical background or as pure device manufacturers) face the more significant task of building or acquiring that capability.
In practical terms, transitioning from a reporting posture to an analytical one means several things: reviewing device safety data at defined intervals using statistically appropriate methods; maintaining a governance framework that creates an auditable trail of signal detection decisions; and assessing linked drug and device safety data in relation to each other, not in isolation.
The organisations best positioned for the regulatory scrutiny ahead will be those that already understand what their data shows — because they did not wait for a regulatory query before embarking on the analytical work.
References
1. US FDA, FDA Activities Related to Essure. Bayer discontinued US sales of Essure at end of 2018 following a black box warning (2016), sales restrictions (April 2018), and more than 73,000 medical device reports filed with the FDA between 2002 and 2024. https://www.fda.gov/medical-devices/essure-permanent-birth-control/fda-activities-related-essure
2. DePuy Orthopaedics voluntarily recalled its ASR Hip Resurfacing System and ASR XL Acetabular System in August 2010 after National Joint Registry data showed 5-year revision rates of 12–13%. Johnson & Johnson subsequently settled claims globally for $2.5 billion. Health Sciences Authority (Singapore), citing MHRA Medical Device Alert MDA/2010/033. https://www.hsa.gov.sg/announcements/safety-alert/recall-of-medical-devices---depuy-asr-hip-resurfacing-system-and-depuy-asr-xl-acetabular-system
3. European Commission Medical Device Coordination Group, MDCG 2025-10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices, December 2025. https://health.ec.europa.eu/latest-updates/mdcg-2025-10-guidance-post-market-surveillance-medical-devices-and-vitro-diagnostic-medical-devices-2025-12-19_en
4. MDCG draft guidance on trend reporting under MDR/IVDR (MDCG 2025-X), September 2025. Summary: Advena Ltd, MDCG Releases Draft Guidance on Trend Reporting. https://www.advenaltd.eu/2025/09/mdcg-releases-draft-guidance-on-trend-reporting/
5. UK Government / MHRA, MHRA guidance on new Medical Devices Post-Market Surveillance requirements. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 came into force 16 June 2025. https://www.gov.uk/government/news/mhra-guidance-on-new-medical-devices-post-market-surveillance-requirements
6. US FDA, Quality Management System Regulation (QMSR) Final Rule, aligning 21 CFR Part 820 with ISO 13485:2016. https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/quality-management-system-regulation-qmsr-final-rule
7. NMPA Center for Medical Device Standardization Administration, draft national standard "Post-Market Surveillance for Medical Device Manufacturers," issued July 19, 2024 (equivalent to ISO/TR 20416:2020). Summary: ChinaMedDevice, Medical Devices PMS Standard: Aligning China’s Regulatory Framework with Global Requirements, September 2024. https://chinameddevice.com/post-market-surveillance-for-medical-device-manufacturers/
8. National Medical Products Administration (China), Announcement No. 63 of 2025: Measures to Optimize Whole Life-Cycle Regulation in Support of the Innovative Development of High-End Medical Devices, October 2025. https://english.nmpa.gov.cn/2025-10/14/c_1138492.htm
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