Regulatory newsletter - Edition 8

Welcome to the eighth edition of Trinzo’s regulatory newsletter – your one-stop shop for the latest developments in the regulatory landscape! It just so happens to be our final installment of 2023, so it's sure to be a good one. From up-and-coming trends to analysis, our team of industry experts comb through content around the globe to deliver the most pertinent issues in your industry.

So, what are the latest updates in the regulatory sphere? Grab a hot drink of your choice, sit back and check out the latest news. ? Remember to share with a friend if you found it helpful, and subscribe to make sure you never miss an edition.

FDA

FDA has announced its withdrawal from the Global Harmonization Working Party (GHWP) in a publicly released letter. This move will see the FDA focus its efforts primarily on working with the IMDRF, with the aim of advancing global harmonisation and making safe and effective medical devices available globally.

Two guidance documents have been released in relation to Section 506J of the FD&C Act, which requires manufacturers to notify the FDA in the event of discontinuations or interruptions to the manufacture of devices that would lead to disruption in the supply of that device during a public health emergency.

• Final guidance on: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act
• Draft guidance on: Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.

FDA's CDRH has announced that three consensus standards will be recognised in relation to medical device software safety. The three standards are:

• ANSI AAMI 2700-2-1:2022 - Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging.
• ANSI AAMI SW96:2023 - Standard for medical device security - Security risk management for device manufacturers
• ISO IEC IEEE 29119-1 Second edition 2022-01 - Software and systems engineering - Software testing - Part 1: General concepts

EU

MDCG 2022-11 has been updated to Revision 1, with the addition of a section "Call to notified bodies to streamline the certification process" and a revision to the section "Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay".

This follows concern surrounding the continued availability of medical devices in the EU as the revised deadlines for compliance to the MDR and IVDR approach. While notified bodies have increased their capacity, June 2023 data indicates that both applications and subsequent certifications are low, especially for IVDs.

The guidance also includes data comparing the numbers of QMS and product applications with certifications, showing a significant contrast in these figures. For example, while 9,071 QMS applications were received by June 2023, only 2,682 certificates had been issued by that time. Similarly, 4,106 MDR applications had been submitted, with just 1,217 certificates issued.

A 36-month study was initiated in December 2022 to support the monitoring of medical device and IVD availability on the EU market. As part of this study, the European Commission has released a survey for manufacturers and authorised representatives of medical devices and IVDs that will be marketed in the next 2 years. The deadline for the completion of the survey is 15th January 2024.

The European Commission has released the results of a notified body survey on MDR and IVDR certifications and applications. The data in the survey was collected in July 2023 and relates to the time period up to 30th June 2023. Data was requested, and received, from all notified bodies who had been designated under the regulations up to that point. The aim of the survey is to support the monitoring of the availability of medical devices in the EU. It includes data on the applications received, the certificates that have been issued, and the time that it takes to achieve certification. The survey also compares the results with those of previous surveys.

MedTech Europe has released a position paper on The Future of Europe's Medical Technology Regulations, expressing concerns with the structural issues in the current regulatory system. It is thought that these issues cannot be resolved by the implementation of the MDR and IVDR alone, and a three-point vision for a future system is introduced:

• An efficient CE marking system - an efficient, more predictable, less burdensome system
• A system that works for innovation - the inclusion of an innovation principle and dedicated assessment pathways
• An accountable governance structure - a single dedicated structure to govern the regulatory system

Regulation (EU) 2023/2713 has been published in the Official Journal, in relation to designation of EU reference laboratories for IVDs. Annex I of this regulation references the laboratories that have been designated for devices intended for the detection or quantification of markers for the following:

• hepatitis or retrovirus infection (2 laboratories)
• herpesvirus infection (3 laboratories)
• infection with bacterial agents (3 laboratories)
• respiratory virus infection (2 laboratories)

UDEM Belgelendirme A.S (# 2292) and Scarlet NB B.V. (# 3022) have become the 41st and 42nd notified body to be designated under MDR respectively.

Australia

The TGA have released new guidance on the use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices and IVDs. This positive development will allow applicants to use overseas approvals to access an abridged assessment of submissions made to the TGA.

An updated revision to TGA's guidance on Clinical Evidence Guidelines for Medical Devices has been released. The updates include:

• New chapters on ophthalmic devices and devices incorporating a medicine,
• Changes to surgical mesh and breast implants and tissue expander,
• References to real-world data and real-world evidence
• Changes reflecting recent TGA experience with clinical evidence

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