.png)
NEWSLETTER
April Regulatory Newsletter
Welcome to our April regulatory newsletter!
This publication is designed to keep you up-to-date on the latest changes and developments in the regulatory landscape. From new regulations, FDA updates to AI and Cybersecurity news, we aim to provide you with the information you need to stay informed and compliant.
Industry Updates
Warning letter for Abbott; job cuts at Medtronic; and stricter standards proposed for EO sterilised devices
-
Abbott Point of Care has been issued with an FDA warning letter following an inspection of it's Ottawa site. This is resulting from unapproved significant changes that were made to a diagnostic myocardial infarction device which was originally introduced in 2003.
-
As part of a cost cutting measure, Medtronic are planning additional global job cuts to a portion of its workforce of almost 100,000 worldwide. The locations and numbers of the redundancies have not yet been confirmed.
-
The EPA is proposing stricter standards for the use of ethylene oxide. While a reduction would reduce pollution and airborne toxins, it would also likely lead to a shortage of some types of sterile medical devices.
Europe Updates
Team NB release the results of their 2022 member survey and an update to their MDR technical documentation best practice position paper; Swissmedic’s reaction to recent MDR and IVDR amendments
-
Team NB have released the results of their 2022 member survey related to medical device and IVD registration in the EU. This report documents the responses from their 33 members, providing a breakdown in information on the types of certificates issued, notified body size and growth, and the progress of the transition from directives to regulations
-
Team NB have updated their position paper on “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of MDR”. This update comes as a result of experience gained by notified bodies in their technical documentation review. Among other updates, this version expands upon reasons for review delays and common issues that are being seen during reviews.
-
In order to avoid a shortage of medical devices in Switzerland, Swissmedic has released a notification that medical devices which are covered by a certificate that is valid under the MDR and IVDR amendments, may also be placed on the Swiss market.
FDA Updates
CRS report on FDA medical device regulation; adoption of IEC 60601-1 by the FDA
-
Team NB have released the results of their 2022 member survey related to medical device and IVD registration in the EU. This report documents the responses from their 33 members, providing a breakdown in information on the types of certificates issued, notified body size and growth, and the progress of the transition from directives to regulations.
-
In order to avoid a shortage of medical devices in Switzerland, Swissmedic has released a notification that medical devices which are covered by a certificate that is valid under the MDR and IVDR amendments, may also be placed on the Swiss market.
-
In January of this year a report was released by the Congressional Research Service on the FDA Regulation of Medical Devices. This report provides an overview of the FDA medical device regulation, touching on topics such as classification, registration activities and PMS. It is particularly useful for anyone new to the US regulations.
-
On April 3rd, IEC 60601-1 was added to the FDA's list of recognised consensus standards. While use of this standard for medical electrical equipment is voluntary, FDA will accept a Declaration of Conformity when the two US national differences are applied.
Australia Updates
TGA release software guidance, surveys for POC devices and make an update to their EP checklist for personalized devices
-
TGA has released a guidance document on the regulation of software based medical devices. This guidance provides links to various related TGA publications that will aid manufacturers in complying with software requirements. Feedback on the guidance is welcomed by TGA.
-
TGA has released four surveys intended to gather information from different stakeholders involved in point-of-care medical device manufacturing. The surveys are open until 7th May, and the results will feed into the development of regulatory pathways for POC manufacturing.
-
TGA has released an update to their Essential Principles Checklist to include clauses relating to personalised medical devices and to improve usability
AI & Cybersecurity News
IMDRF releases two new documents related to cybersecurity; NIST releases AI glossary and Council of Europe publish an overview of committee AI activities
-
The Council of Europe has released a publication giving an overview of the activities of their various committees in the field of AI.
-
The US National Institute of Standards and Technology (NIST) has released an in-depth glossary of terms related to AI. The guide is intended to be sufficiently flexible to allow its use by all sectors. An overview can be found here and the glossary can be downloaded from here.
-
IMDRF has published a new document on "Principles and Practices for the Cybersecurity of Legacy Medical Devices". This guidance is intended to complement the N60 guidance document (Principles and Practices for Medical Device Cybersecurity) and focuses on the potential for patient harm with legacy devices containing, or existing as, software.
-
IMDRF has released a technical document on "Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity". The SBOM concept is intended to improve cybersecurity risk management processes in the Total Product Lifecycle of medical devices.
New & Updated Guidance Documents
MHRA releases software guidance and updates their vigilance guidance; new Q&A from the FDA on clinical investigations; IMDRF releases PMS guidance for national competent authorities
-
MHRA has released a new guidance document on software (including AI) as a medical device. The guidance consolidates several resources intended to support SaMD manufacturers.
-
MHRA has updated their vigilance guidance with information on API submissions to the new MORE portal.
-
MHRA has released an update to their guidance document on medical device registration, to include guidance on the registration of devices with an expired CE certificate that remains valid under the MDR transitional provisions.
-
MHRA has released further information on the implementation of future regulations in the UK. The aim is for core elements of the future medical device regulation to come into effect from July 2025. This publication also contains information on the transitional arrangements and timelines.
-
FDA has released a new Q&A guidance document on a risk-based approach to the monitoring of clinical investigations. The guidance contains 8 questions split over three sections: Monitoring Approach, Monitoring Plan Content, and Follow-Up Communication of Monitoring Results.
-
IMDRF has released a guidance and information document entitled "Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form". This document is aimed at the relevant competent authorities and outlines the criteria for the exchange of information and provides forms for such activities.