Our MedTech news roundup for January 2025 covers the amended IvDO, MedTech Europe’s 2024 Regulatory Survey results, the latest endorsement of the COMBINE programme, and the MHRA’s guidance on reportable incidents.
MedTech news from the US also features, spanning guidance from the FDA on AI-enabled device software functions, its PMA and HDE modular review program, and PCCPs tailored to AI-enabled medical devices. Guidance from Health Canada regarding T&Cs for Class II – IV medical devices is also highlighted.
And don’t miss the MedTech updates from China, Australia, and Brazil on GMP standards, regulatory harmonisation, and a new clinical investigation database respectively.
Read on for more…
MedTech news from Switzerland, the EU & UK
Amended IvDO enters force
The amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO) entered into force on 1 January this year. The amendment sees Switzerland’s implementation of extended transitional periods in line with the EU Regulation, restoring regulatory equivalence with the EU.
The adoption last June of Regulation (EU) 2024/1860 amending IVDR regarding the transitional provisions for certain IVDs and amending MDR and IVDR regarding a gradual EUDAMED roll-out has extended the validity of certificates issued under the old legislation in the EU to 2027, 2028, or 2029 (depending on risk class) to address notified body bottlenecks.
According to Swissmedic, this, together with the planned permanent simplification of mandatory labelling for devices dispensed by professionals should ensure the supply of IVDs in Switzerland.
MedTech Europe survey results reveal regulatory concerns
MedTech Europe has shared the results of its 2024 Regulatory Survey, offering valuable insights into the evolving regulatory landscape for MedTech in the EU. The results highlight the challenges manufacturers are facing with the MDR and IVDR – as companies become increasingly concerned about costs, timelines, and regulatory predictability.
EU Member States endorse COMBINE programme
The end of last year saw national authorities in EU Member States endorse a new strategy for the COMBINE programme, an EU cross-sector initiative that streamlines combined studies of medicines and medical devices, including diagnostics.
The COMBINE project was initiated to address the issues linked to the operational interface between the EU clinical trials, medical devices, and in vitro diagnostic medical devices regulations, to ultimately reduce the time to market for innovative and personalised treatments.
The programme aims to foster collaboration between national authorities responsible for clinical trials and medical devices, as well as the EU Commission, European Medicines Agency, ethics committees, sponsors, clinicians, and patient representatives.
Read more on the programme here.
MHRA shares examples of reportable incidents
In December last year, the UK’s MHRA finalised its Post-Market Surveillance statutory instrument (PMS SI). In guidance published on 15 January, the MHRA shares examples of incidents that manufacturers must report under its medical device vigilance system. With the aim of emphasising the importance of PMS, in line with the EU MDR and EU IVDR, the PMS SI will come into force in June this year.
MedTech news from the US & Canada
Draft guidance from the FDA on AI-enabled device software functions
This month the FDA published draft guidance on Artificial Intelligence (AI)-enabled device software functions related to lifecycle management and marketing submissions.
The draft guidance document provides recommendations regarding the contents of marketing submissions for medical devices that include AI-enabled device software functions including documentation and information that will support the FDA’s evaluation.
The guidance also proposes recommendations for the design, development, and implementation of AI-enabled devices that manufacturers may wish to consider using throughout the total product life cycle (TPLC).
The draft guidance is open for comments until 7 April, and available to read here.
FDA publishes final guidance on PMA and HDE modular review program
Released this month, this FDA final guidance provides information on the Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) modular review program and the procedures for submitting or reviewing a modular PMA or HDE.
The modular review program is an alternative to the preparation, submission, and evaluation of traditional PMAs and HDEs. Recommended for products in the early stages of the clinical study, the approach is intended to provide a mechanism by which applicants may submit non-clinical data and manufacturing information for review while still collecting, compiling, and analysing the clinical data using the final device design. As the FDA describes, a modular PMA or HDE is essentially a compilation of sections or “modules” submitted at different times that together become a complete application.
Find out more on the modular review program here.
FDA issues recommendations for PCCPs tailored to AI-enabled devices
Last month the FDA issued final guidance which provides recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices, with the aim of supporting iterative improvement through device modifications while continuing to provide a reasonable assurance of device safety and effectiveness.
The guidance recommends that a PCCP describes the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications.
Health Canada outlines T&Cs for Class II – IV medical devices
Set to come into force in January 2026, the guidance at the link below from Health Canada explains how the terms and conditions for Class II – IV medical device licences under subsection 36(2) of the MDR are imposed and amended. The purpose of the T&Cs is included, as well as the process that’s applied when T&Cs are imposed, amended, or removed.
MedTech news from China, Australia, & Brazil
China’s NMPA shares updated GMP standards
On 15 January, China’s NMPA published the new draft “Medical Device Manufacturing Quality Management Standards”. The proposed revision aligns more closely with the internationally recognised ISO 13485 standard, establishing risk-based GMP principles.
The updated document incorporates more detailed regulations, expanding on the 82 provisions in the 2014 version, to 131. Implementation practicality has also been improved with more precise term definition.
See here for more on the new draft and submit feedback until 14 February.
China’s regulatory reforms aim to encourage foreign manufacturers
On 3 January, the General Office of the State Council issued the “Opinions on Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry”.
Calling for comprehensive regulatory reform and the promotion of high-quality development in the healthcare sector at a national level, the Opinions highlight several benefits for overseas medical device manufacturers. Accelerated approval for clinically urgent products and rare disease treatments, priority approval for high-end devices, and priority testing for innovative medical devices are amongst the key focus areas, as well as steps towards alignment with international standards.
Australia’s TGA continues regulatory harmonisation advancement
This month, the TGA updated its guidance on transitioning to new manufacturer evidence for in-vitro diagnostic medical devices (IVDs), as part of efforts to advance regulatory harmonisation.
The updated guidance includes changes in line with the further extension of EU IVDR timelines and changes to Regulation 5.3 of the Therapeutic Goods (Medical Device) Regulations 2002.
TGA previews new guidance on PRAC
The TGA has this month announced a preview of new guidance on corrective actions. The new Procedure for Recalls, Product Alerts and Product Corrections (PRAC) aims to “simplify and modernise the existing process to report and execute corrective actions for drugs, biologicals and medical devices”. The PRAC will take effect in March this year.
For more on the guidance preview, see here.
Brazil’s ANVISA publishes clinical investigation database
At the end of last year, Brazil’s ANVISA released its database on clinical investigations. Providing information about the clinical investigations in Brazil authorised by ANVISA, the database allows users to filter by medical device category, material or equipment, and year, as well as between investigations that have been cleared, cleared with clinical investigation completed, or cleared with investigation started. Explore the database here.
That concludes our January 2025 MedTech news roundup. We’ll be back at the end of February with more medical device news and updates.
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