EU MDR & IVDR Insider
November 2025 Special Issue
A free publication from AKRA TEAM
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The paradigm shift from adverse event reporting to global safety monitoring.
By Philippe Auclair, Ph.D.
Regulatory Affairs Expert | AKRA TEAM
ABSTRACT
Harmonization efforts are advancing, driven by harmonization groups and shared tools like coding of adverse events programs, but they're far from complete. The tension between global alignment and regional sovereignty keeps Post-Market Surveillance (PMS) fragmented. For manufacturers, this means navigating a semi-harmonized landscape—benefiting from shared standards where they exist but still adapting to local specificities.
Challenges to harmonization are significant—spanning security, interoperability, language barriers, and the fluidity of international trade—but not insurmountable thanks to technological advances, industry momentum, and political engagement.
"Post-market requirements are transforming from passive adverse events collection toward proactive, remote and integrated systems."
IN THIS ARTICLE
PART 1: HARMONIZATION STATUS
1. Introduction
2. What Are Post-Market Device Harmonization Efforts?
3. Key Harmonization Initiatives
PART 2: HARMONIZATION STATUS
4. Critical Evaluation and Challenges to Harmonization
5. Perspectives for Future Developments
6. Recommendations for Manufacturers
7. Current Conclusion
1. INTRODUCTION
Post-market requirements are changing, transforming existing historical systems based on passive adverse event collection toward a proactive, remote and integrated systems. Beyond these reporting obligations, the system creates the foundation for being used as a tool for creating a better picture of device safety and performance with the use of advanced technologies.
Harmonization initiatives are underway to limit regional requirements and specificities.
2. WHAT ARE POST-MARKET DEVICE HARMONIZATION EFFORTS?
Post-market surveillance harmonization strives to align standards, processes, and requirements for monitoring medical devices. The objective is to ensure consistent safety, performance, and quality oversight across countries while reducing duplication of efforts for manufacturers and regulators.
PMS involves collecting and analysing real-world data (e.g., adverse events, device performance) to identify risks, improve devices and protect patients.
3. KEY HARMONIZATION INITIATIVES
Global Harmonization Task Force (GHTF) Legacy
Though replaced now by IMDRF, GHTF's foundational documents (e.g., SG2 on vigilance reporting- document N54) still influences PMS standards. It emphasizes that uniform adverse event definitions and reporting timelines constitute the foundation of many, if not all, PMS regional requirements.
While largely used and accepted, these are limited by manual collection and country individual reporting.
International Medical Device Regulators Forum (IMDRF)
The IMDRF, formed in 2011, is the leading global harmonization platform for medical devices and IVDs.
It includes regulators from Australia, Brazil, Canada, China, EU, Japan, UK, US (FDA), Singapore, South Korea, as well as several Affiliate Members and Official Observers.
IMDRF has developed guidance documents which allow for coding and exchange of Adverse events data and recalls between members to satisfy multiple countries' requirements, including post-market obligations. Notable documents are IMDRF N14, and a common coding system (Annex A medical device problems; Annex B Cause Investigation- Investigation type; Annex C Cause investigation- Investigation findings; Annex D Cause investigation – investigation conclusion; Annex E Health Effects – clinical sign, symptoms and conditions; Annex F Health Effects Health impact; Annex G Components) to ensure consistency of reporting.
EU Medical Device Regulations (MDR/IVDR)
The EU MDR (2017/745) and IVDR (2017/746) tightened PMS requirements, mandating proactive monitoring (e.g., Post-Market Clinical Follow-up, PMCF) and periodic safety update reports (PSURs).
While not fully harmonized with non-EU systems, it aligns with IMDRF principles and encourages international data compatibility via the EUDAMED database.
The system remains complex, with redundancies between the mandatory reports, creating complexity to produce and increasing costs for manufacturers as PMCF often requires setting up new clinical studies.
Global Harmonization Working Party (GHWP)
Formerly called the Asian Harmonization Working Party, GHWP includes Industry representation and member economies (more than 32 to date). It is to be noted that the membership largely overlaps with the IMDRF (China, Japan, Singapore for example), while the US FDA, briefly a member, cancelled its membership in November 2023.
Guidance documents are largely aligned on IMDRF, with ambition to coordinate data between member economies. This is limited in its impact due to variations in capacity between advanced members.
"Countries like Singapore, Brazil, South Korea, US FDA, EU, Japan, Canada, Australia, China mandate or allow use of IMDRF coding system enabling cross-country incidents and recalls tracking."
Pan American Health Organization (PAHO)
While PAHO does not itself directly conduct PMS, it collaborates with national authorities across member countries, organizing capacity building and training for members. The REDMA system supports the sharing of information on adverse events involving medical devices to improve safety and regulatory oversight across the Americas.
Currently 25 national regulatory authorities are part of it. The system still faces challenges with underreporting, harmonization between countries and low resource to process reports. PAHO is an official observer at IMDRF.
World Health Organization (WHO) and Emerging Markets
The World Health Organization supports harmonization in low- and middle-income countries through its original 2021 PMS guidance, aligning with IMDRF frameworks to build capacity where regulatory systems are less developed.
WHO does not operate a centralized, mandatory database for medical device adverse events. Instead, it focuses on supporting harmonization by training and providing guidance, standards, and support to countries for improving safety and surveillance of medical devices.
4. CRITICAL EVALUATION AND CHALLENGES TO HARMONIZATION
Notable successes have been achieved. Countries such as Singapore, Brazil, South Korea, the U.S., the EU, Japan, Canada, Australia, and China mandate or allow the use of the IMDRF coding system, enabling cross-country tracking of incidents and recalls.
That being said, hurdles remain which limit harmonization:
Remaining Regulatory Divergence
The EU's proactive PMS (e.g., PMCF plans) contrasts with the FDA's more reactive approach (e.g., reliance on adverse event reports via MAUDE). Japan's PMDA, meanwhile, blends both but has unique local requirements.
This creates a patchwork where manufacturers must tailor PMS systems to each market, undermining full harmonization.
Geopolitical and Ethical Considerations
Despite progress, regulators prioritize local (i.e., national) patient safety over global consistency, and geopolitical tensions (e.g., US-China trade issues) result in slow data- sharing agreements.
Changes in laws and regulations locally are slow or difficult to achieve, and local sovereignty is a resistance to relying on data provided by another country for local decision making.
Resource Disparities
Collection of data on device performance relies on individuals and company goodwill. Advanced economies have robust PMS infrastructures (e.g., EUDAMED), but developing economies often lack the technology or trained personnel to participate fully in harmonized systems.
Data Sharing Barriers
Privacy laws (e.g., GDPR in the EU, HIPAA in the US) complicate cross- border data exchange. Standardizing formats and ensuring cybersecurity while respecting these laws is a persistent issue.
Despite the potential to share information thanks to the IMDRF coding system, the absence of a global central database limited access and transmission remain ad hoc and not fully coordinated. While the EU has developed an e-reporting form integrating the IMDRF codes, this form cannot be used by other parts of the world due the lack of alignment of IT systems.
Interoperability
Most PMS device reports come from manufacturers or healthcare institutions and use varying standards or protocols, making it hard to integrate them into a unified healthcare system. The IMDRF codes are not widely used by healthcare professionals and its sustainability in time can be questioned.
There's a push for standardized protocols (e.g., HL7, FHIR) to improve compatibility, but adoption is slow, especially in resource-limited settings.
"The multiplicity of initiatives for harmonization unfortunately tends to complicate the picture and creates divergences."
5. PERSPECTIVES FOR FUTURE DEVELOPMENTS
Cost and Accessibility
High upfront costs for devices, infrastructure (e.g., bandwidth, cloud storage), and maintenance can limit adoption, particularly in low-income regions or underfunded healthcare systems. Patients may also lack access to compatible technology.
Perspective: Some see potential in low-cost, scalable solutions (e.g., mobile-based PMS), but balancing affordability with quality is an ongoing debate.
Technical Reliability
Issues like network connectivity (especially in rural areas), device calibration, and sensor accuracy can disrupt real-time monitoring. For example, a poorly calibrated device might give false readings, leading to misdiagnosis or delayed treatment.
Perspective: Advances in wearable tech and AI are improving reliability, but ensuring consistent performance across diverse environments remains a hurdle.
User Adoption and Engagement
Patients and healthcare providers may resist using existing processes due to complexity, lack of training, or distrust in technology. For instance, elderly patients might struggle with wearable devices, while clinicians might find data overload overwhelming.
Perspective: User-friendly designs and education are seen as key to boosting adoption, with a focus on tailoring systems to specific demographics.
Regulatory and Ethical Concerns
Compliance with medical regulations is complex and time-consuming. Ethical issues, like ensuring informed consent or managing data ownership, also arise.
Perspective: Regulators are adapting, with faster approval tracks for digital health tools, but ethical frameworks lag behind technological advancements.
Expectations of Various Stakeholders
While aligned on safety, various stakeholder groups differ in focus:
- Regulators prioritize systemic oversight, identification of emerging risks to protect public health and compliance enforcement to verify that manufacturers adhere to post-market obligations.
- Patients value continued access to devices and transparency, with a desire to clear communication about device performance via healthcare providers or public notices, empowering them to take informed decisions.
- Healthcare professionals bridge the gap with practical application and seek rapid notifications about safety concerns and product training, but most importantly without disruptions of practice. They want an easy process channel for reporting of device issues and to see the findings acted upon to improve devices.
- Manufacturers want to see these expectations balanced with operational, legal demands and reduce the ever-spiralling cost of maintaining divergent systems.
This multi-stakeholder framework drives post-market device management globally, adapting as technology and regulations evolve.
6. RECOMMENDATIONS FOR MANUFACTURERS
Here are some key recommendations meant to foster compliance and progress towards harmonization of PMS systems:
1. Develop an All-Encompassing Global PMS System
Establish a systematic process to proactively collect and analyse data on your devices after they enter the market. Data collected should be comprehensive enough to fulfil various regional regulatory requirements. For example, the U.S., FDA 21 CFR Part 822, the EU MDR and IVDR requiring Periodic Safety Update Report (PSUR).
2. Monitor and Report Adverse Events in Time
Implement procedures to promptly identify, document, and report adverse events promptly. In the U.S., manufacturers must comply with Medical Device Reporting (MDR) requirements, while in the EU, vigilance reporting under MDR and IVDR includes shorter timelines for serious incidents. Given divergence on reporting timelines, adopt the strictest requirement to be able to comply with various requirements.
3. Practice 'Harmonization by Doing'
Develop a standard reporting form for Vigilance internally, and try to push it (or an existing regional form) for reporting in countries without established reporting forms. For example, experience has demonstrated that multiple geographies accept EU form even if the local requirements are somehow different.
4. Engage with Stakeholders
Collaborate with healthcare providers, patients, and regulators to gather feedback and advocate on benefits of PMS harmonization.
5. Automate and Streamline with Technology
Use Quality Management System (QMS) software to automate data collection, analysis, and reporting. This reduces errors and ensures compliance with complex requirements like ISO 13485:2016, which includes PMS as part of quality assurance.
Stay informed about emerging technologies for data collection and analysis. Artificial Intelligence developments offer promising perspectives to analyse safety information, including Real World Evidence data.
"Industry could demonstrate the gain to use new technology in terms of reducing costs for establishing a robust and reliable early warning system for devices based on worldwide data collection and analysis."
7. CURRENT CONCLUSION
Harmonization efforts are advancing, driven by harmonization groups and the development of electronic coding systems for data exchange.
The growing number of harmonization initiatives, unfortunately, tends to complicate the landscape and create divergences. This leads to confusion for compliance and increased cost for maintenance and use.
Challenges to harmonization are significant (security, interoperability, languages, implications of the fluidity in international trade) but not insurmountable, thanks to technological advancements (global database / AI tools and more generally reliance on the Internet of Things), but industry impetus and political engagement are needed.
Industry should continue to work in cooperation with the various harmonization groups and try to get them closer together. Having hi-tech knowledge, Industry could demonstrate the gain to use new technology in terms of reducing costs (for both national authorities and manufacturers) for establishing a robust and reliable early warning system for devices based on worldwide data collection and analysis.
Editor’s Note
The European Commission has signaled that a major package of MDR and IVDR revisions will be released before the December holidays.
Early indications suggest the update will touch several high-pressure areas: capacity relief measures, adjustments to legacy device provisions, refinements to surveillance obligations, and steps toward more efficient oversight. What this will mean for post-market surveillance, including PMCF expectations, vigilance structures, and reporting pathways, is still unknown. The proposals are expected to influence how manufacturers plan and maintain PMS systems, especially in light of the fragmentation, interoperability challenges, and harmonization pressures outlined in this issue.
AKRA TEAM will host a webinar shortly after the announcement to break down the Commission’s revisions and discuss practical implications for manufacturers, Notified Bodies, and regulatory teams. Details will follow.
About the Author
Philippe Auclair, Ph.D.
Regulatory Affairs Expert | AKRA TEAM
Dr. Philippe Auclair brings over 30 years of experience in pharmaceuticals and the medical device/IVD industry. He holds a Ph.D. in Microbiology and Enzymology from the University of Technology Compiègne (1984) and a Pharmacy degree from the University of Clermont-Ferrand (1983).
Dr. Auclair has played pivotal roles in global harmonization efforts, serving as Secretary of the Global Harmonization Task Force (GHTF) Study Group 2 on Adverse Event Reporting and currently serving as a Technical Committee Advisor for the Global Harmonization Working Party (GHWP).
He previously served as Chairman of the Post-Market Surveillance Task Force and Clinical Investigation Task Force for EUCOMED (now MedTech Europe), the European confederation of medical device manufacturers. As an industry representative in European Commission expert groups on vigilance and clinical evaluation, and an expert in several ISO/CEN committees, Dr. Auclair has been instrumental in shaping international standards for post-market surveillance.
Among his recognitions, Dr. Auclair has received the FDA CDRH Director's Special Citation and the RAPS Global Leadership Award. He has been elected as a RAPS Fellow in acknowledgment of his contributions to regulatory science.
About AKRA TEAM
AKRA TEAM is a diverse team of high-level expert consultants dedicated to assisting stakeholders in all steps towards bringing medical devices, in-vitro diagnostics, and combination products to market.
Our experience and knowledge are applied to ensure timely product launches in full compliance with complex legal and regulatory requirements
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