Our June 2025 MedTech news covers the recent guidance from the MDCG on the interplay between the MDR/IVDR and the AIA, and the qualification and classification of software under the MDR/IVDR. Updates on the COMBINE programme and the EU public procurement market for medical devices from China also feature, along with the latest on the MHRA AI Airlock and new medical device standards from the NMPA. For all this and more, read on.
MedTech news from the EU
MDCG shares guidance on interplay between the MDR/IVDR and AIA
On 19 June, the MDCG released an FAQ on the interplay between the EU MDR and IVDR and the Artificial Intelligence Act (AIA).
Whilst the MDR and IVDR requirements address risks related to medical device software, they do not explicitly address risks specific to AI systems. In this regard, the AIA complements the MDR/IVDR by introducing requirements to address hazards and risks for health, safety, and fundamental rights specific to AI systems.
Primarily aimed at medical device manufacturers, notified bodies, and competent authorities, the FAQ document provides a first set of answers to questions related to the joint application of the AIA and the MDR or IVDR. Access the FAQ here.
COMBINE programme launches pilot coordinated assessment
This month, the COMBINE programme launched a pilot coordinated assessment for clinical trials and performance studies.
The COMBINE project was initiated to address the issues linked to the operational interface between the EU clinical trials, medical devices, and IVD regulations, to ultimately reduce the time to market for innovative and personalised treatments.
Aiming to test a new, more efficient, and more harmonised way of approving combined studies, this latest pilot launched by the EU Commission and EU Member States has been designed to allow sponsors to submit a single application. Find out more about the pilot here.
MDCG updates guidance on qualification & classification of software in MDR & IVDR
The 17 June saw the publishing of MDCG’s updated guidance on qualification and classification of software in MDR and IVDR.
Following a day after the publication of the MDCG 2025-4 guidance on the safe making available of MDSW apps on online platforms, the update includes a refined scope to include artificial intelligence, an enhanced interpretation of Rule 11, and a reinforcement of the concept of modular medical device software that highlights the need for the individual definition and documentation of each module’s intended purpose.
Furthermore, Annex XVI now includes additional examples of scenarios of products without an intended medical purpose, the European Health Data Space (EHDS) is referenced, and you’ll also find an additional example that demonstrates when MDSW could be confidently classified as low risk.
Read the full MDCG 2019-11 Rev.1 guidance here.
EU approves restriction to EU public procurement for medical devices from China
At the start of this month, EU Member States approved the adoption of measures under the International Procurement Instrument (IPI), aimed at addressing imbalances regarding access to the public procurement market for European medical devices in China. Consequently, medical devices originating from China will face new restrictions when accessing EU public tenders.
For more on this from MedTech Europe, see here.
MDCG publishes Q&A on performance studies under IVDR
On 18 June, MDCG published a Q&A containing information for sponsors of performance studies of IVDs conducted within the scope of the IVDR.
Manufacturers providing IVDs for use in performance studies that may be sponsored by other actors, and sponsors of combined studies may also find the document’s content relevant.
As well as general questions regarding performance studies according to the IVDR, the document includes information on specific performance study requirements, additional requirements for certain types of studies, timeline considerations, and substantial modifications. Read the full Q&A here.
EMDN Helpdesk now officially live
The EMDN Helpdesk service is now ready to respond to requests on the European Medical Device Nomenclature.
The service aims to provide users with information on the nomenclature structure (category/groups/types) as well as any useful information to enable manufacturers to choose the appropriate EMDN code(s) for their medical devices and IVDs. Find out more here.
MedTech news from the UK
MHRA opens AI Airlock Phase 2 applications
The MHRA AI Airlock launched in Spring 2024. As the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products, the objective of AI Airlock is to “identify regulatory challenges to AIaMD and work collaboratively to understand and potentially mitigate any risks that are uncovered”.
Stakeholders will be able to use the AI Airlock product reports to share knowledge and findings to assist with further funding or assessment activities.
This month, the MHRA has opened applications for the AI Airlock Phase 2. According to the MHRA, successful candidates will benefit from a unique collaboration of industry and regulatory experts as well as a bespoke testing plan, and gain an improved understanding of the current regulatory framework.
To find out more about the AI Airlock, see here. And to apply to participate in Phase 2, see here.
MHRA publishes documentation for data requirements implementation under the new PMS regulations
This month, the MHRA published a range of documentation for the implementation of data requirements under the new Post-Market Surveillance regulations. The documentation supports changes made to sharing Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) with the MHRA following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. Read more on this here.
MedTech news from China
New medical device standards to take effect in July
This month, China’s NMPA announced that 36 medical device standards will take effect in July this year – including three national standards for cardiovascular implants. These newly established or revised standards aim to assist manufacturers with local type testing and regulatory submissions, whilst improving consistency with international counterparts. Find out more here.
NMPA reviewers share insight on dental implant structural design
NMPA reviewers have this month shared their insight on dental implant structural design to provide advice for product development, registration, and evaluation. In their article published on 20 June, they summarise the current state of dental implant structural design and discuss key technical review considerations based on regulatory experience. Read the full article here.
That concludes our June 2025 MedTech news roundup. We’ll be back in August with more medical device news and updates.
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