Our MedTech news for September 2024 covers new procedures from Swissmedic for submitting clinical trials applications, the latest from EMA regarding the use of LLMs, and a survey from the EU Commission on eIFU for medical devices used by healthcare professionals. New draft guidances from the FDA are also included, related to its ASCA Program and chemical analysis for medical device biocompatibility assessment respectively. And an historic proposal from China’s NMPA regarding its medical device regulation also features. Read on for all this and more…
MedTech news from Switzerland & Europe
Swissmedic releases new procedures for submitting clinical trials applications
Following the adoption of amendments for four ordinances related to the Human Research Act (HRA RS 810.30) in June this year, Swissmedic has this month released updated instructions, templates, and checklists to facilitate the transition before and after the implementation of the amended ordinances. Entering into force from 1 November this year, the amendments seek to strengthen the protection of research participants and aim to improve the regulatory framework for researchers. The provisions on transparency will become applicable on 1 March 2025.
Swissmedic updates information on IVD performance studies
At the start of this month Swissmedic updated its information on performance studies with in vitro diagnostics. The update includes new submission forms, information on the categorisation of performance studies, and a decision tree to help determine whether a research project must be submitted to Swissmedic. Find out more here.
Team NB adopts transfer agreement for legacy devices
The agreement specifying the terms of the transfer of the appropriate surveillance activities according to Art. 110 (3e) of Regulation (EU) 2017/746 was adopted by Team NB on 11 September. In this context, appropriate surveillance activities include documentation review, audits, or other kinds of assessments performed by a Notified Body (NB) in relation to a legacy device. The agreement can be signed between the incoming NB, the outgoing NB, and the certification holder. Find out more on this here.
EU Commission requests feedback on eIFU for medical devices
The EU Commission has launched a survey to gather feedback regarding the use of Electronic Instructions for Use for all medical devices used by healthcare professionals. Healthcare professionals and others working for healthcare institutions can participate in the five minute survey here, until 11 October 2024.
MedTech news from US, Canada, & China
FDA issues draft guidance on chemical analysis for medical device biocompatibility assessment
On 20 September, the FDA issued the draft guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices. The draft guidance, once finalised, is intended to describe recommended methodological approaches to chemical analysis for the biocompatibility assessment of medical devices. It also aims to improve consistency and reliability of analytical chemistry studies submitted as part of premarket submissions to demonstrate device biocompatibility. You can read the draft guidance here. And to learn more about the fundamentals of biocompatibility, register for our upcoming webinar here.
FDA issues draft guidances on ASCA Program
The FDA’s voluntary Accreditation Scheme for Conformity Assessment (ASCA) Program is an accreditation scheme that “capitalizes upon the increasingly prominent role that standards play in regulatory science and practice”. Together with the FDA, the ASCA aims to facilitate timely and continued access to safe, effective, and high-quality medical devices.
This month, the FDA issued three draft guidances that include updates to the ASCA program based on recent feedback:
- The Accreditation Scheme for Conformity Assessment (ASCA) Program describes the goals and operation of the ASCA Program as required by section 514(d) of the FD&C Act.
- Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program provides information on how the biological evaluation of medical devices standards are incorporated into the ASCA.
- Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program provides information regarding how basic safety and essential performance standards are incorporated into the ASCA.
Find out more about the ASCA Program here.
NMPA proposes historic changes for medical devices in China
China’s NMPA has proposed historic changes to its medical device regulation that demonstrate the country’s intention to increase its medical device development and quality level. The major changes that impact foreign companies include those on innovation devices policy, international multi-center clinical trials, clinical trial approvals, and the registration renewal time window. Find out more on this here.
Combination products news
EMA issues guiding principles on use of large language models
On 5 September EMA issued a set of principles and recommendations for the use of large language models (LLMs) by regulatory agencies in the context of the EU artificial intelligence (AI) workplan. The aim is to further clarify the capabilities and limitations of LLMs across the European Medicines Regulatory Network (EMRN). A factsheet for the safe and responsible use of LLMs has also been made available by the agency.
CTR collaborate stakeholder meeting explores clinical affairs solutions
On the 11 September, the Clinical Trials Coordination Group (CTCG), supported by the ACT EU Priority Action on Mapping and Governance, held the Clinical Trials Regulation (CTR) collaborate stakeholder meeting. Attended by MPP, the meeting highlighted the progress of the project, discussed challenges across Member States, and explored potential solutions to harmonize procedures, improve safety standards, and promote clinical research in the region. You can view the meeting presentation here.
The Clinical Trials Coordination and Advisory Group (CTAG) has also endorsed the updated guidance for CTR Regulation (EU) 536/2014, which was published by the EU Commission at the end of last month.
That concludes our September 2024 MedTech news roundup. Check back in October for more medical device news and updates.
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