Regulatory Newsletter - Edition 13

We're back with the 13th issue of Trinzo’s regulatory newsletter – your one-stop shop for the latest developments in the regulatory world! Our team of industry insiders have been busy combing through content around the globe, from emerging trends to in-depth analysis.

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 the final rule for laboratory developed tests (LDTs). The rule will be phased in over a 4 year period and will bring LDTs under the control of the Food, Drug, and Cosmetic Act. Historically the FDA has not enforced FD&C Act requirements on most LDTs due to the low volume and low risk of these devices. However, in recent years they have been more widely used and there has been growing concern about the accuracy of some tests. This rule will increase FDA oversight and result in safer and more effective LDTs in the long-term.

In relation to the release of the final rule on LDTs, FDA has also released two draft guidance documents:

• Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564. This guidance outlines the FDA's enforcement policy for certain laboratory manufacturers who may offer unauthorised IVDs for the immediate response to chemical, biological, radiological, or nuclear agents. Comments on the draft guidance are accepted until 5th July and can be submitted here.
• Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency. This guidance outlines the factors that the FDA will consider in the decision to issue an enforcement policy for the use of unapproved tests during an emergency. Comments on the draft guidance are accepted until 5th July and can be submitted here.

MDR & IVDR

MDCG 2024-5 has been released providing guidance on the content of the Investigator's Brochure for clinical investigation of medical devices. The Investigator's Brochure is designed to provide information on technical and clinical data related to the subject device, meeting the requirements of Annex XV, Chapter II, Section 2 of the MDR.

The 45th and 46th notified bodies have been designated under MDR - TUV SUD Denmark (#2443) and AFNOR Certification (#0333) respectively.

The European Parliament has voted by an overwhelming majority to accept the amendment that was proposed in January to implement a gradual rollout of EUDAMED and to extend of the transition period for certain IVDs moving to IVDR conformity. Publication in the EU Official Journal is expected next month. The full text surrounding the proposal can be accessed here.

MDCG 2024-4 has been released in relation to safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. This guidance outlines the procedures for the reporting of adverse events in performance studies, in the absence of a functional EUDAMED module. It relates to performance studies performed under Articles 58(1), 58(2), 70(1), and 70(2) of the regulation, as well as combined IVD/medicinal product studies.

An update has been made to MDCG 2022-9 on the summary of safety and performance template, bringing this guidance to Rev. 1. The changes to this revision include a clarification on when the SSP should be made available to patients, and an update of the terminology "intended use of the device" to "intended purpose and other indications".

Rest of World

TGA has released a consultation paper on the availability of instructions for use in more flexible formats. This publication contains several consultation questions regarding the potential expansion of the scope of the devices for which the use of an e-IFU is permitted and the associated requirements associated with any changes. Responses these questions are welcomed until 28th May 2024. Submissions can be made here.

Off the back of the introduction of the FDA final rule on LDTs, TGA has updated their regulatory requirements for in-house IVDs. This update includes the introduction of a new in-house IVD notification template and guidance on its completion, in addition to clarification on responsibilities and the inclusion of case studies.

The MHRA has released a updates to their guidance on notification requirements regarding a clinical investigation for a medical device. These updates include the provision of updated guidance on Combined IMP Devices, electrical guidance for clinical investigations, and guidance for manufacturers.

A policy paper has been released by the MHRA on the impact of AI on the regulation of medical products. This publication examines the role that the MHRA play in relation to three different perspectives:

• Part 1: The MHRA as a regulator of AI products
• Part 2: The MHRA as a public service organisation delivering time-critical decisions
• Part 3: The MHRA as an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties

AI

The European Parliament have released a short publication on artificial intelligence and cybersecurity. The paper outlines three different dimensions in the relationship between AI and cybersecurity for consideration:

• the cybersecurity of AI
• the use of AI to support cybersecurity
• the use of AI for malicious purposes.

TüV SüD are holding a webinar on 11th June on Understanding AI Act Interactions with MDR/IVDR. This information session is intended for AI providers and device manufacturers. It will examine the challenges arising from the different legal frameworks and provide insight into regulatory strategies and best practice guidance. Register for this free event here.

In Other News...

The IMDRF has recently released three new guidance documents directed towards medical device manufacturers:

• Final guidance on Principles of Labelling for Medical Devices and IVD Medical Devices: This document is intended to provide globally harmonised guidance on the content of device labels, instructions for use, and any other material that is intended for the patient to support the safe and effective use of devices.
• Final guidance on Medical Device Regulatory Review Report: Guidance Regarding Information to be Included. This document relates to medical devices only (not IVDs) and provides an overview of the information that IMDRF Regulatory Authorities require of regulatory review reports and the format that these reports should take, within the context of regulatory submissions.
• Final guidance on Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices. This document provides a harmonised view of essential principles for safety and performance of devices and describes those essential principles that should be considered in the design and manufacture of medical devices.

A new standard (ISO/IEC DTS 17012) "Guidelines for the use of remote auditing methods in auditing management systems" is under development. Once approved, this standard will provide guidance on the use of a risk-based methodology for conducting remote audits, providing assurance that a remote audit is carried out effectively and that audit objectives are achieved.

Voting on the draft is ongoing and will close on 14th May 2024.

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