Regulatory Newsletter: Edition 6

?? Happy Friday and welcome to the sixth edition of Trinzo’s regulatory newsletter – your one-stop shop for the latest developments in the regulatory landscape! From up-and-coming trends to analysis, our team of industry experts comb through content around the globe to deliver the most pressing issues in your industry.

September has been a busy month in the regulatory sphere, so grab a cup of coffee and dive right in. ? Don’t forget to share with a friend if you found it helpful, and subscribe to make sure you never miss an edition!

Industry News

McKinsey & Company have released a comprehensive report on MedTech Pulse: Thriving in the Next Decade. This report examines how a reinvention of the MedTech industry could increase the value that it provides to both patients and industry shareholders and states that transformative rather than gradual change is required to achieve this, including consideration of increased acquisitions.

FDA News

The final version of FDA's guidance on Electronic Submission Template for Medical Device 510(k) Submissions has released. The move to electronic submissions has taken effect as of 1st October 2023. This guidance provides support and resources to users of electronic submissions, including relevant terminology, the format, structure and use of the current submission template, and information related to template waivers and extensions.

Final guidance has been released on the topic of Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This document supersedes the April 2022 released draft, and its 2014 predecessor, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The guidance provides recommendations for the cybersecurity information that should be included in device submissions to both CDRH and CBER.

Final guidance on the Breakthrough Devices Program has been released by FDA, superseding the October 2022 draft version. The program, which replaces both the Expediated Access Pathway and the Priority Review Program, is intended to expediate the review of breakthrough devices in order to allow faster patient access to new technologies.

An amendment has been proposed by the FDA to explicitly state in its regulations that IVDs are considered devices under the FD&C Act, inclusive of those IVDs manufactured by a laboratory, meaning that laboratory developed tests (LDTs) would face the same enforcement process as other IVDs under the regulations. Comments are being accepted on this proposal until 4th December 2023.

EU Updates

MedTech Europe, along with 34 other signatories, has released an open letter to the the European Commissioner for Health and Food Safety, Stella Kyriadkides. The letter outlines concerns regarding the structural issues with the regulatory framework surrounding the implementation of MDR and IVDR, and suggests a collaborative effort towards the structural reform that is required for the achievement of the objectives of the new regulations.

The EU Commission has released a Q&A document on the transitional provisions for products without an intended medical purpose, covered by Annex XVI of MDR. The document is intended to provide general guidance for the facilitation of the application of the transitional provisions according to Commission Implementing Regulation (EU) 2022/2346, as amended by Commission Implementing Regulation (EU) 2023/1194.

A new notified body has been designated under IVDR - Eurofins Electric & Electronics Finland Oy (#0537).

MHRA Updates

MHRA has launched an Innovative Devices Access Pathway (IDAP). This new programme is designed to support manufacturers of innovative technologies with support and advice, with the overall aim of expediating patient access to these technologies. Eligible devices must not have a CE mark, a UKCA mark, or any other regulatory approval, and must address a currently unmet clinical need. Applications for the programme are now open.

An update has been made to guidance on Medical devices: EU regulations for MDR and IVDR (Northern Ireland). This update is a replacement of "Temporary Disapplication of Sponsors and Legal Representatives in Northern Ireland" with "Clinical investigations and performance studies in Northern Ireland". The result of this change is that the MHRA will disapply the requirement for a sponsor or legal representative of a clinical investigation or performance study to be established in Northern Ireland or the EU, provided that predefined conditions are met.

Canada Updates

Health Canada has released draft guidance for determining medical device application type. The Medical Devices Regulations lists five different application types:

• medical device family
• medical device group
• medical device group family
• system
• test kit

This guidance intends to aid manufacturers in determining whether their devices can be combined and submitted under a single application/device licence, or whether individual authorisations are required as a "single medical device".

Draft guidance has been released by Health Canada on Pre-market Guidance for Machine Learning-Enabled Medical Devices. The guidance is intended for manufacturers who are making new or amended submissions for Class II, III and IV machine learning-enabled medical devices and addresses the supporting information that should be considered for demonstrating the safety and effectiveness of these devices.

Cybersecurity and AI

The EU Commission has released a publication on Cybersecurity of Artificial Intelligence in the AI Act. The report looks at the cybersecurity requirements related to high-risk AI systems, and outlines guidance for achieving compliance with the AI Act. The report can be downloaded from here.

In other news...

A second edition of ISO 10993-17 on Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents, has been published, 21 years after the release of the first edition. It is intended that the updates in this revision will contribute to a reduction in the time required for the preparation of toxicological risk assessments.

The IMDRF working group responsible for Personalised Medical Devices (PMD) has released a second edition of their guidance document on regulatory pathways for PMDs. The guidance aims to promote a more harmonised approach to the regulation of such devices, and includes an overview of relevant considerations for the development of a harmonised assessment approach for different jurisdictions in the future.

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