Regulatory Newsletter Edition 10
Welcome to the tenth edition of Trinzo’s regulatory newsletter! Our team of industry experts have been combing through content around the globe, from up-and-coming trends to analysis, to deliver the biggest news in your industry direct to your screen.
Let's dive right into your one-stop shop for the latest developments in the regulatory landscape. ?? Don't forget to hit the subscribe button to make sure you never miss an edition, and share with a friend who might find it helpful!
FDA
FDA has released the CDRH 2023 Annual Report , providing an overview of the center's activities over the year. Most notable is the authorisation of 124 novel device, the highest number yet. Additionally, the report provides information on MDUFA V and device safety, innovation, and shortages.
FDA has published the final rule to harmonise the existing Quality System Regulation (21 CFR 820) with the requirements of other jurisdictions, by incorporating the requirements of ISO 13485:2016 by reference throughout the QSR.
The rule is set to become effective on 2nd February 2026.
A brief Q&A was also released in relation to the publication of the final rule.
Draft guidance has been released by the FDA on Conducting Remote Regulatory Assessments. This is a Q&A style guidance responding to the most frequently asked questions on RRAs. RRAs were initially introduced as a result of Covid-19, but their use has now been expanded beyond the pandemic for certain situations. This guidance is intended to promote understanding of the FDA approach to RRAs, and is open to comments until 26th March 2024.
FDA has updated their guidance on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile to include reference to vaporized hydrogen peroxide (VHP) as an established category A sterilisation process.
Draft guidance has been released by FDA on Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices. The document contains pre-market submission recommendations and applies only to class II and class III devices which use the applicable coatings.
Comments are being accepted until 22nd March 2024.
Draft guidance has been released on the Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. The guidance provides recommendations for the adoption of a standardised approach to the collection and reporting of race and ethnicity data intended to be used in submissions to the FDA.
Comments on the draft guidance are being accepted until 29th April 2024.
EU
The European Commission has published a new proposal which would extend the transition period from the IVDD to the IVDR. This is due to the low number of designated notified bodies and the possibility of device shortages following potential bottlenecks down the line. Devices meeting the following conditions can benefit from this extension:
a written agreement is in place between the manufacturer and notified body before September 2025 (class D), September 2026 (class C) or September 2027 (class B and class A sterile).
The new proposed dates for transition are as follows:
In addition to the EU Commission proposal to extend the IVDR transition period, this proposal also addresses the adoption of a gradual roll-out of EUDAMED. The current provisions mandate the use of the database only when all modules have been declared fully functional. However, it is now being proposed that the use of the modules that are already available should become mandatory without the requirement to wait for all modules. This means that the mandatory use of most modules could start by the end of 2025. The current status is as follows:
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In relation to the proposal on extending the IVDR transition period and adopting a gradual approach to the EUDAMED roll-out, the European Commission has also released a Q&A document. The document can be downloaded from here .
MDCG 2024-1 has been released, addressing Guidance on the vigilance system for CE-marked devices. This guidance has four sub documents which deal with Device Specific Vigilance Guidance (DSVG). The aim of the guidances are to promote a harmonised apporach to vigilance reporting and to outline the way in which incidents should be reported for specific device types. The four DSVGs are as follows:
MDCG 2024-1-1 : DSVG 01 - Devices for Cardiac Ablation
MDCG 2024-1-2 : DSVG 02 - Coronary Stents and associated delivery systems
MDCG 2024-1-3 : DSVG 03 - Cardiac Implantable Electronic Devices (CIEDs)
MDCG 2024-1-4 : DSVG 04 - Breast Implants
MDCG has published a “Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)”. This document is intended to provide focus on where the limited available resources should be directed in order to achieve full IVDR implementation. It’s presented as two sets of priorities and further broken down into sub-priorities in those groups, giving an overview of the timeline and status of each action within the groups:
The European Commission has published information providing an overview of the language requirements for medical devices, according to the different member states. The information is presented in two separate tables - one for MDR , and another for IVDR . It covers the language requirements for the following types of information accompanying a device:
MHRA
The MHRA has published their roadmap towards the future regulatory framework for medical devices. The roadmap includes a timeline on what was delivered between 2021 and 2023 and what's planned for 2024, heading into 2025. A caveat is provided that states the document is subject to updates and does not take into account any potential future impacts resulting from a General Election in the UK.
An update has been made to the MHRA guidance on notification about a clinical investigation for a medical device. This update includes the addition of a template for the submission of quarterly summary reports, which are to be used to provide updates on the latest safety profile for the investigation.
Two new UK approved bodies have been designated by the MHRA - LNE-Gmed UK and Scarlet NB UK. This brings to 9 the total number of bodies available to certify devices in the UK.
AI
WHO has released a new publication on Ethics and governance of artificial intelligence for health: Guidance on large multi-modal models (LMMs). There are 5 LMM uses identified in the text:
The guidance also provides 40 recommendations for the use of LMMs to ensure that the patient health is protected.
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