Regulatory Newsletter - Edition 15

We're back with the latest 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.

Take a few minutes to 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

Following publication of the final rule on LDTs, the FDA has issued guidance on Laboratory Developed Tests: Small Entity Compliance Guide. The guidance is intended to support small entities to achieve compliance with the IVD requirements established by the FDA.

Draft guidance on addressing misinformation about medical devices and prescription drugs has been released by the FDA. The purpose of the guidance is to allow members of the public and healthcare professionals get the most accurate and up to date information possible to inform their decisions related to healthcare. This guidance includes a Q&A section, providing hypothetical examples of different scenarios for each question posed.

Draft guidance has been released on Essential Drug Delivery Outputs (EDDO) for Devices Intended to Deliver Drugs and Biological Products. EDDOs are defined as the design outputs necessary to ensure delivery of the intended drug dose to the intended delivery site. The scope of this guidance includes, but is not limited to, devices such as syringes, injectors, infusion pumps, nasal sprays and inhalers. Comments on the guidance should be submitted to FDA by 29th September 2024.

FDA has released draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This guidance is intended to ensure that historically underrepresented patient populations are included in relevant clinical studies to improve the associated evidence for intended use populations. The document describes the content of a Diversity Action Plan, along with timelines, waivers, and the types of studies which will require submission of these plans.

Comments on this draft guidance are welcomed until 26th September 2024.

EU

"Regulation (EU) 2024/1860 Of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices" has been published in the EU Official Journal. This publication marks the official implementation of a gradual rollout of EUDAMED and the extension of the transition period for certain IVDs moving to IVDR conformity.

The European Commission has published an updated timeline for the gradual roll out of Eudamed and a view of the module functionality, following the publication of Regulation 2024/1860. According to the current plan, notices on the use of actor, UDI/device, notified body and certificates, and market surveillance modules will be published in the Official Journal in July 2025. The Vigilance module is planned for Official Journal publication in January of 2026. The use of these modules will become mandatory 6 months after these publications. The updated timeline can be viewed here.

The Notified Bodies Coordination Group has released NBCG-MED 2024-1 on the application of hybrid audits to quality management system assessments under MDR/IVDR - operational elements. This guidance reflects the position of notified bodies on what aspects must be considered in the application of a hybrid approach to QMS audits. It includes examples of what systems may be suitable for auditing via information and communication technologies (ICT) and what aspects must be audited on-site, along with auditor qualification requirements and considerations regarding audit planning and duration.

MDCG 2024-10 has been released, providing guidance on clinical evaluation of orphan medical devices. The guidance relates only to devices and accessories with an orphan indication, and which require clinical data to demonstrate GSPR conformance.

Part A of the guidance covers Clinical Evaluation Considerations and Part B relates to the Procedural Considerations, including notified body activities and expert panel involvement.

There are also three helpful appendices which reference the following topics:

• information specific to orphan devices which should be included in the CER,
• considerations for conducting clinical investigations, and
• the extrapolation of data to support orphan indications.

The full guidance document can be accessed here.

MDCG 2022-13 on the Designation, re-assessment and notification of conformity assessment bodies and notified bodies, has been updated to Revision 1. This update was made to include guidance on conducting joint assessments related to extending the scope of designations.

MDCG 2021-5 guidance on standardisation for medical devices has been updated to Revision 1. This guidance relates to standards in the medical device industry, which are intended to support the EU regulatory requirements as laid out by MDR and IVDR. Updates have been made throughout the guidance including, but not limited to:

• removal of references to the EU directives (AIMDD, MDD and IVDD)
• additional considerations related to EN ISO 15189 and ISO 14155:2011
• updates on harmonised standards (HAS) consultants
• updates on IMDRF
• updates to state of the art

MDCG 2020-16 guidance on the classification rules for IVDs within the scope of IVDR has been updated to Revision 3. This update includes the following changes:

• a definition has been provided for a "kit",
• the examples provided under rule 3(a) on "devices for detecting the presence of, or exposure to, a sexually transmitted agent", have been revised,
• the content related to rule 4(a) on self-testing devices, and rule 5(c) on specimen receptacles has been revised,
• there has been a minor revision to the example provided under rule 6, the "catch-all" rule.

Team NB have released a position paper in relation to transfer agreements for the surveillance of legacy devices, specifying the terms of the transfer of the appropriate surveillance activities according to Article 120 (3e) of MDR, in respect of legacy devices covered by a certificate issued in accordance with the AIMDD or MDD. This position paper, taking the form of a transfer agreement template, outlines all the requirements that should be considered in the surveillance of legacy devices during the period of transition to MDR.

The European Commission has released slides from an information session that was held on 4th July, on The EU Regulations on medical devices and in vitro diagnostic medical devices. This presentation provides an overview of the current state of play for the implementation of both MDR and IVDR. Of note, there are currently 49 notified bodies designated under MDR, with 13 applications ongoing. There are 12 notified bodies designated under IVDR, with 9 applications ongoing. The slides can be accessed here.

ROW

Guiding principles on the transparency of machine learning enabled medical devices have been jointly identified by the MHRA, FDA, and Health Canada. The guiding principles consider the following aspects:

• Who (the relevant audiences)
• Why (the motivation)
• What (relevant information)
• Where (the placement of that information)
• When (timing)
• How (what methods are used to support the transparency)

TGA has released updates to the Australian medical device regulation. These changes relate to:

• software-based medical devices (effective since 15th June 2024)
• prescription spectacle lenses (effective since 15th June 2024)
• medical devices containing microbial, recombinant, or animal substances (effective since 1st July 2024)
• medical device application audit requirements (effective since 1st July 2024)

A roadmap for bringing IVDs to the Australian market has been released by TGA, aimed at IVD sponsors. The guidance, which is still under review, takes the form of a flow chart outlining all the necessary steps to achieve ARTG inclusion and market access. Detailed footnotes and links to additional useful information are also included.

In other news...

The IMDRF Artificial Intelligence/Machine Learning-enabled Working Group has released a draft document on good machine learning practice (GMLP) for medical device development: guiding principles. The 10 GMLP guiding principles are intended to be a call to action for international stakeholders to advance GMLP. The 10 principles can be summarised as:

1. A well understood device intended purpose
2. Implementation of good design, security practices and software engineering
3. Clinical study participants are representative of the intended population
4. Training datasets are independent of test sets
5. Reference standards are fit for purpose
6. Tailored and suitable model choice and design
7. Performance assessment focused on human-AI team
8. Performance tested in clinically relevant conditions
9. Clear and essential information provided to the user
10. Monitoring of deployed models for performance and management of re-training risks

Comments are being welcomed on the draft guidance until 30th August 2024.

The Association for the Advancement of Medical Instrumentation (AAMI) has updated its standard on the use of ethylene oxide sterilisation (ANSI/AAMI ST24:2024). This is the first update to this standard in 25 years and the new edition reflects the current use of EtO sterilisers following the changes that have taken place since 1999. The update provides information on labelling, safety, performance, registrations, and test methods.

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