Regulatory Newsletter - Edition 12
We're back with the twelfth edition of Trinzo’s regulatory newsletter – your one-stop shop for the latest developments in the regulatory world! Our team of industry insiders have combed through content around the globe, from emerging trends to in-depth analysis, so you get the most pertinent issues in your industry direct to your screen.
So grab a coffee, sit back and read the latest updates 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
The FDA has released draft guidance on Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. This document proposes updates to the existing guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. Once the content of this draft document has been approved, it will be added to the existing guidance as a new section on the cybersecurity information that the FDA considers necessary to support the obligations under section 524B (on cybersecurity) of the FD&C Act.
The FDA are hosting a webinar on 30th April to discuss this draft guidance. Attendance can be registered here.
EU
The European Commission has published two implementing decisions regarding the use of harmonised standards for medical devices. This includes the following additions:
The 44th notified body has been designated under MDR - RISE Medical Notified Body AB (#3033)
MDCG 2024-3 has been released by the European Commission, providing guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices. Section 3 of Annex XV of the MDR details the CIP requirements. This guidance document is formed around the relevant MDR section to allow for alignment and cross-referencing with the requirements of the regulation. It was also developed taking the content of ISO 14155:2020 on clinical investigations into consideration.
An update has been released to the European Commission published document on the national language requirements for manufacturers under IVDR. This revision includes an update to the French requirements for the documents required for conformity assessment and the addition of English for certain parts of this documentation.
RoW
An update has been published to MHRA guidance on the regulation of devices in Northern Ireland. This update relates to the entry into force of the MDR and IVDR and also the application on MDCG guidance.
In Australia, the TGA have updated their guidance for sponsors in relation to the supporting documentation requirements for inclusion of a medical device in the ARTG.
AI
The European Parliament has approved the AI Act, which is designed to implement a uniform legal framework for placing on the market, putting into service and using AI systems in the EU.
MedTech Europe has released a publication, presenting a medical technology industry perspective on the final AI Act. The document presents the following recommendations:
EPA
The EPA has announced a final rule regarding the use of ethylene oxide sterilisation. The rule is designed to drastically cut emissions of EtO and subsequently reduce the risk of cancer for the communities most affected by these emissions. The rule provides compliance timelines, with the facilities posing the greatest risks required to comply within two years and the facilities with the lower emissions required to comply within three years.
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