Three themes from the session
1. The MDR arc: from overcorrection to recalibration
When MDR first took effect, manufacturers faced a documentation and clinical evidence burden that many had not anticipated. Nine years into that arc, Dr. Akra described a shift in how regulators and legislators themselves are reading the history of the regulation. A proposed MDR 2.0 revision is already in discussion, driven by recognition that uniform application of the original requirements creates real risks for patient access.
“Today, expectations are becoming more balanced. We are already discussing a future revision of the regulation that will scale back some of these requirements, because the European legislature has recognized that nine years of experience with MDR have not been ideal. If we continue on the current path, many devices may disappear from the market, and patients may lose access to treatments they have relied on for years.”
Dr. Bassil Akra, EU MDR Expert, Founder and CEO, AKRA TEAM (approx. 4:13)
The proposed revision is not settled law, but the signal it sends is meaningful. The regulatory community is beginning to separate data collection that serves patient safety from data collection that serves administrative compliance.
2. Not every device needs active PMCF data collection
One of the most practically useful points of the session was a clarification many manufacturers have missed. Post-Market SurveillanceThe systematic process of continuously collecting and evaluating data on a medical device after it is placed on the market, as required by EU MDR Article 83. is a universal obligation under MDR. Post-Market Clinical Follow-upA subset of PMS that involves active clinical data collection, such as registries or studies, required only when deemed necessary to address residual clinical concerns (MDR Annex XIV, Part B). is not.
“Not every device is required to carry out active PMCF, whether that takes the form of a clinical investigation, a registry, or a dedicated post-market study. That obligation only arises when it is deemed necessary for that specific device.”
Dr. Bassil Akra, EU MDR Expert, Founder and CEO, AKRA TEAM (approx. 9:02)
For manufacturers of well-established devices, Dr. Akra recommended auditing current PMCF commitments to separate what is genuinely required from what was added out of caution or a misread of the guidance. For devices that have been on the market for 30 or 40 years with a well-understood safety profile, active data collection that does not address a specific residual risk adds administrative burden without adding patient safety value.
3. AI changes the ROI calculation for data collection
The third theme was how AI tools are changing what is practically achievable in real-world evidence generation for device manufacturers. Derk Arts described how Castor Catalyst supports AI-assisted extraction from electronic health records, with a direct-to-patient data retrieval pathway through FHIR and HIPAA release in the US. In Derk’s description, extracted data is reviewed and validated before ingestion into the study registry, reducing the burden on clinical sites while maintaining data integrity for the submission.
For manufacturers where data collection does add clinical value, tools like this lower the practical threshold for running a targeted PMCF program. The decision on whether to collect data at all, however, remains a regulatory and clinical judgment. Dr. Akra framed the role of AI in this space as a tool for amplifying human expertise, not replacing it.
“AI is not replacing human beings. It is empowering us as individuals and as experts. And with that empowerment comes the responsibility to demonstrate how we intend to use it.”
Dr. Bassil Akra, EU MDR Expert, Founder and CEO, AKRA TEAM (approx. 31:23)
Five sections to watch in the full recording
The session goes deeper on several questions that came up repeatedly in the live Q&A:
- 9:02 How to determine when PMCF is actually required under MDR, and how to read “deemed necessary” in practice when auditing existing commitments
- 14:46 What notified bodies are accepting as real-world evidence in EU PMCF submissions today, and how those criteria have shifted since MDR’s launch
- 23:03 How the direct-to-patient data retrieval workflow operates end to end, including how FHIR-extracted data is processed and ingested into the study registry
- 39:00 A discussion of which manufacturers benefit most from AI-assisted data collection and where legacy established devices sit on that spectrum
- 43:06 Dr. Akra’s recommended steps for engaging your notified body today, including how to prepare for a structured dialogue about PMCF obligations vs. self-imposed commitments
Watch both speakers work through specific manufacturer scenarios and respond to audience questions in real time.
Castor supports medical device manufacturers with decentralized data collection and clinical trial solutions designed for real-world evidence generation. Learn more about Castor’s PMCF offering here.
Frequently asked questions
Is PMCF required for all medical devices under EU MDR?
No. Post-Market Surveillance (PMS) is a universal obligation for all medical devices under EU MDR (Regulation EU 2017/745). PMCF, the active clinical data collection component, is required only when it is deemed necessary to address specific residual risks, device safety questions, or to confirm the benefit-risk profile of the device. Manufacturers of well-established, lower-risk devices may be able to demonstrate continued compliance through literature surveillance and complaint analysis without running a dedicated PMCF study or registry. The key criterion is whether active clinical data collection adds value for patient safety or risk management, not whether it satisfies an administrative checklist.
What is the difference between PMS and PMCF under EU MDR?
Post-Market Surveillance (PMS) is the systematic process of continuously collecting and evaluating data on a device once it is on the market. It covers complaint handling, vigilance reporting, trend analysis, and literature review. Post-Market Clinical Follow-up (PMCF) is a specific subset of PMS that involves active clinical data collection, such as running a registry, conducting a post-market clinical study, or gathering structured real-world evidence from clinical settings. PMS is mandatory for all devices. PMCF activities are required only when existing clinical evidence does not sufficiently address remaining clinical concerns or when the device benefit-risk profile has not been fully characterised through pre-market data.
Can AI-assisted chart review be used in PMCF submissions under EU MDR?
AI-assisted chart review with human oversight is increasingly being explored as part of real-world evidence generation for post-market submissions. Notified bodies are evaluating AI-assisted approaches case by case, with data quality, traceability, and documented methodology as the key criteria. Submissions that use AI tools for data extraction need to demonstrate that a qualified reviewer has validated the extracted data and that the process is auditable. Manufacturers planning to use AI-assisted approaches in a PMCF methodology should discuss the approach with their notified body before committing to a study design, as regulatory expectations for AI-generated evidence are still developing.