MDCG 2025-5: Q&A Regarding Performance Study Requirements Under the IVDR
30 June 2025
EUDAMED Mandatory Use: Insights and Timeline from the June 26, 2025 MDCG Working Group Meeting
14 July 2025Below is an overview of the June 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., eIFUs now allowed for all professional use medical devices, MDCG 2019-11 on software qualification and classification revised.
Vigilance Reporting
Minor Updates to EU MIR Form
EU Manufacturer Incident Report (MIR) form 7.3.1 was published 5 May 2025, replacing the old version 7.2.1.
A few minor updates were made to Form 7.3.1 after publication, and it was republished again in June 2025.
New UK Device-specific Vigilance Guidance
The MHRA published additional Device-specific vigilance guidance for coronary stents, inferior vena cava filters, artificial heart valves, and cardiac implantable electronic devices. It is available: HERE
MHRA PSUR Template Updated
The MHRA published an updated version of their Periodic Safety Update Report (PSUR) template: HERE
Master UDI-DI
Commission Adds Master UDI-DI Section to UDI Webpage
There is now a section covering Master UDI-DI: HERE
It includes links to Commission Delegated Regulations and MDCG guidance documents. The page notes that two new MDCG guidance documents are pending:
“MDCG 2025-XX Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles (under development)”
“See also MDCG 2025-XX Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles (under development)”
As well, that Commission Delegated Regulation amending Master UDI-DI for contact lenses is in process. It aims to extend the compliance deadline by one year, giving companies more time to adjust their processes. The proposed new applicability date would be 9 November 2026.
“Commission Delegated Regulation (EU) …/… of 16 April 2025 amending Delegated Regulation (EU) 2023/2197 as regards the date of application (under scrutiny)”
Master UDI-DI: Spectacles, Frames, Lenses, & Ready-to-Wear Reading Spectacles
The Delegated Regulation on Master UDI-DI for spectacles, frames, lenses, read-to-wear reading spectacles has been adopted: HERE
It will enter into force on the 20th day after its publication in the Official Journal of the EU, followed by a 3-year transition period. However, companies can voluntarily comply earlier, if they choose (and the Commission encourages).
Team Notified Body Updates
2024 Annual Sector Survey
Team NB published results from its annual survey of notified bodies.
Key takeaways:
- Membership up 23% from 2023, with 43 members, including candidate members.
- Breakdown by size: 17% large (1000+ certificates), 32% medium (300–1000), 51% small (under 350).
- MDR certificate share: Team NB members issued 79% of all MDR certificates in 2024.
- IVDR certificate share: 100% of IVDR certificates issued by Team NB members.
- Significant rise in Annex XVI (devices without a medical purpose) submissions and certificates. Submissions more than doubled, certificates quadrupled.
- Class D IVD applications up 73%, certificates up 170%.
- Notified bodies added more technical staff (26% increase) and subcontractor resources (22% increase).
- Persistent documentation quality challenges: 75% of files still require substantial additional information at submission.
Position Paper on IVD software
Team NB published a Position Paper on medical device software (MDSW) under the IVDR: HERE
Their IVD Software Working Task Force members updated the position paper to simplify the decision tree and improve terminology. Further, to now make it publicly available. Team NB confirmed that V1 was an internal document only and not publicly released.
This position paper:
- Clarifies when software is considered an IVD MD, an accessory, or neither.
- Provides examples of software not considered an MDSW under the IVDR, e.g., a Non-Diagnostic Data Visualization Tool, that visualizes lab data, such as graphs or charts, to aid in administrative decision-making without providing any clinical interpretation or diagnostic recommendation
- Provides a decision tree for the qualification of software as an MDSW under the IVDR, including example devices
Artificial Intelligence
MDCG 2025-6: Q&A on the AI Act & Interplay with the MDR/IVDR
MDCG 2025-6 is available: HERE
Background
The Artificial Intelligence Act (AIA) entered into force on 1 August 2024. However, most of the Act will not start applying until 2 August 2026.
The AIA creates new legal requirements for high-risk AI systems, and many medical devices that use AI will fall under this category. Therefore, they will face compliance obligations under both the AIA and the MDR or IVDR (as applicable). Including, potentially, conformity assessment by a Notified Body for each legislation.
MDCG 2025-6 explains how to apply both sets of rules at the same time, to help avoid duplication.
Overview of MDCG 2025-6
It provides Q&A-style guidance on how the AIA and MDR/IVDR interact.
Key takeaways include:
- “Manufacturer” under MDR/IVDR = “Provider” under AIA.
- “User” under MDR/IVDR ≠ “Deployer” under AIA. These roles differ.
- The AIA applies to devices that include AI systems. If the device is subject to third-party assessment under the MDR/IVDR, the AI system is likely “high-risk” under the AIA.
- In-house devices (Art. 5(5) MDR/IVDR) are not subject to AIA high-risk requirements.
- Shared requirements under both frameworks include:
- Lifecycle Management: Continuous oversight required for AI systems, even after deployment.
- Quality Management System (QMS): the AIA and the MDR/IVDR both require a QMS. You can integrate the AIA’s QMS elements into your MDR/IVDR system.
- Risk Management: the AIA adds new elements, e.g., bias, data quality, and impact on fundamental rights.
- Data Governance: Training, testing, and validation datasets must be high-quality, representative, and appropriately managed. Data bias must be addressed.
- Transparency & Human Oversight: Must be clear that the system uses AI; Users must receive understandable instructions; Explainability and traceability of outputs are required.
- Cybersecurity: Must be designed into the system. The MDR/IVDR and AIA both address this. The AIA goes further for AI-specific vulnerabilities.
- If the MDR/IVDR conformity assessment requires involvement of a Notified Body, the AIA assessment process can be integrated accordingly. In this case, the technical documentation for both assessments may be consolidated into a single, unified set.
- The AIA requires validation and performance testing, even if it doesn’t use the same terms as the MDR/IVDR.
- Clinical investigations (MDR) and performance studies (IVDR) count as real-world testing under the AIA.
AI Airlock Opens Round Two Applications
Background
The MHRA’s AI Airlock is a regulatory “sandbox” launched in Spring 2024, to test and evaluate artificial intelligence (AI) as a medical device (AIaMD). The intent of the program is to use real-world products to help guide future guidance and policy.
Under this program, the MHRA works collaboratively with AI developers, NHS, approved bodies, and other experts to identify regulatory challenges around safety, performance, explainability and clinical compliance.
The Update
The first AI Airlock pilot officially concluded in April 2025, and the MHRA is now initiating a second round.
“Eligible candidates for the second cohort must demonstrate that their AI-powered medical device has the potential to deliver significant benefits to patients and the NHS, presents a new treatment approach, and offers a regulatory challenge ready to be tested in the Airlock programme.”
Applications for Phase 2 opened on 23 June 2025 and will close on 14 July 2025. Interested parties may submit their applications: HERE
MHRA & HealthAI Global Regulatory Network
The UK is a founding member of a new network, called the HealthAI Global Regulatory Network: HERE
Its purpose is for regulators to share “early warnings on safety, monitor how AI tools perform in practice, and shape international standards together”.
Other countries are expected to join in the coming months. Ten ‘Pioneer Countries’ have been invited to shape the Global Regulatory Network from the outset.
COMBINE Programme Pilot: Medicines & CDx
The EU Commission and Member States have launched a pilot project to test a new, more efficient way of approving combined studies. It allows sponsors of combined studies to submit a single application, helping to 1) ensure more harmonized interactions with the member states, and 2) reduce administrative burdens.
The pilot will accept a limited number of studies where the same sponsor is testing a medicine and a companion diagnostic (CDx) at the same time.
Sponsors have until 31 August 2025 to submit their “expression of interest”: HERE
IMDRF & MDSAP
MDSAP Website
The Medical Device Single Audit Program (MDSAP) launched its new website: HERE
It includes information such as:
The countries currently participating in the MDSAP program are Australia, Brazil, Canda, Japan, and the US. And MDSAP official observers are the EU, Singapore, UK, and the WHO.
As noted here, 1) the EU sent delegates to the MDSAP Annual Forum in Amsterdam 16-20 June 2025, and 2) the Commission invited the MDCG to nominate experts to attend the combined MDSAP and MDR/IVDR audits, as a learning opportunity, to test and assess the benefits and limitations of the process.
IMDRF AER Webpage Updated
The IMDRF has modernized its Adverse Event Reporting (AER) webpage: HERE
It has digitized the page, allowing users to browse adverse event terminology and codes. The Excel sheets are still available, under the “AET Training and Guidance Documents” tab.
Swiss CFS guidance updated
Swissmedic updated its guidance on certificates of free sale: HERE
Some of the changes are simple (e.g., re-wording sentences, meanwhile the intent is the same). However, there are some more significant changes, such as revising the format for the sample product list.
