October 24, 2023
It's been over two weeks since RAPS Regulatory Convergence 2023 concluded and we're still celebrating its success.
The regulatory excitement was evident. The exhibit halls percolated with the fervor of discussions, the Solutions Circle and Sponsored Presentations were well attended, and the formal sessions were often filled to capacity.
We published our synopsis about European notified bodies, the European In Vitro Diagnostic Devices Regulation (Regulation 2017/746 IVDR), and Medical Devices Regulation (Regulation 2017/746 MDR). Notified Bodies have capacity now. Manufacturers are encouraged to commence the compliance process now and need to sign an application with a Notified Body because the deadline (Regulation 2023/607) is rapidly approaching (26 May 2024), and the application process varies among Notified Bodies.
The clinical evidence process to demonstrate compliance with both the MDR and IVDR is a challenge. There are guidance documents available. There are two upcoming proposed revisions to MEDDEV 2.7/1 Rev. 4. The enterprise pushed for structured dialogues and formal guidance to describe how manufacturers and Notified Bodies could engage in meaningful conversations.
Last, for medical device manufacturers there is an opportunity to transfer one’s Notified Body now.
The U.S. Food & Drug Administration (FDA) expects to incorporate ISO 13485:2016 by the end of 2023. A transition period will be published. FDA inspections are likely to include more reviews of cybersecurity. There are proposed significant changes to the regulation of Laboratory Developed Tests (LDTs) in which requirements for these products become analogous to IVDs and require a 510(k) or de novo submission.
The FDA is committed to the Accreditation Scheme for Conformity Assessment (ASCA) program testing. In this program, the FDA would certify the lab to perform testing to a standard: currently 93 standards are possible. Manufacturers who provide ASCA-compliant test summaries from ASCA labs are expected to benefit from reduced questions about the tests. FDA further states that these reduce the FDA’s time to review this information (by an estimated 90%), although the overall submission timeline is not expected to be reduced.
In our synopsis on eSTAR, we remind manufacturers that eSTAR is compulsory effective October 1, 2023, and there is an expected updated eSTAR version which would include the recent updates made to cybersecurity expectations.
Emergo UL presented on two global topics, the Medical Device Single Audit Program (MDSAP) program and the International Medical Devices Regulator Forum (IMDRF).
There is attention on Artificial Intelligence and Machine Learning (AI/ML), cybersecurity and software. Various global regulators reference or otherwise discuss cybersecurity standards: IEC 81001-5-1 (2021), IMDRF N70 and IMDRF N73. The Ministry of Health Labor and Welfare (MHLW) is expected to require compliance with IEC 81001-5-1 by March 31, 2024.
Device traceability continues to be important. It was reported that 24 countries have now finalized or drafted Unique Device Identifier (UDI) requirements. Unfortunately, not all of these are harmonized.
Last, the importance of a manufacturer’s processes in their Quality Management System was emphasized, especially relating to risk management, biological evaluation, clinical evidence and post-marketing surveillance.
There is tremendous regulatory news and this is shared and discussed each year at RAPS.
We appreciated every manufacturer we spoke with, those familiar with Emergo by UL and those new to us as well.
We love what we do and we will continue to monitor and report on regulatory developments.
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