Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions – Guidance for Industry and Food and Drug Administration Staff was published in February 20261. This final guidance document provides the Food and Drug Administration’s recommendations to…
Technical Reference documents TR-007, Medical Device Software and Cybersecurity and TR-008, Artificial Intelligence Medical Devices have been updated and came into effect on 3 February 2026. TR-007, Medical Device Software and Cybersecurity1 The February 2026 update has modified the…
A technical performance and safety white paper entitled Medical Imaging Device Cybersecurity: Critical Outage Situations and Response was issued by the industry association AdvaMed in August 20251. This technical document outlines common imaging device outage scenarios and manufacturers’ recommended steps for…
A new Technical Reference document TR-007, Medical Device Software and Cybersecurity, was published on 1 September 20251. This document provides an overview of software developed for medical purposes, the concepts and principles for the classification of medical device software under…
The Finnish Medicines Agency (Fimea) has published1 a new online tool that allows operators to assess whether they are covered by national cybersecurity legislation in accordance with the European Union’s Directive (EU) 2022/2555 on measures for a high common level…
Introduction The passage of the update to the Federal Food, Drug, and Cosmetic Act (FFD&C Act) by the US Congress in December 20221 resulted in the addition of section 524B entitled ‘Ensuring Cybersecurity of Medical Devices’, which identifies a cyber…
Guidance for manufacturers and sponsors on the cybersecurity of medical devices that include software or electronic components has been updated to align1 with the Procedure for Recalls, Product Alerts and Product Corrections (PRAC), which replaced the Uniform Recall Procedure for…
The Food and Drug Administration (FDA) has updated the final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions1,2 to identify the cybersecurity information the Agency generally considers to be necessary to support obligations under…
Technical Reference Document TR-007, Software Medical Devices and Cybersecurity, has been updated and became effective immediately1. This TR provides an overview and definitions of medical device software, including software in a medical device (SiMD) and software as a medical device…
As part of the implementation of the Network and Information Systems (NIS) 2 Directive – European Directive (EU) 2022/2555 – which came into force on 1 July 2025, the Danish Agency for Social Security has published new guidance for the…
Stakeholders should submit any comments they may have on a draft Best Practices Guide for Medical Device Cybersecurity by 12 May 20251. This draft document sets out best practice recommendations and considerations for all medical device manufacturers and healthcare providers…
The Danish implementation of the NIS 2 Directive – Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the Union – has been postponed until 1 March 20251. This European Directive replaces the previous NIS 1…
Introduction In Canada, along with the rest of the world, the use of digital health technologies, including software-based medical devices, has risen dramatically. According to Health Canada, digital health technologies and software-based medical devices can improve access to healthcare information,…
Introduction The medical device cybersecurity landscape continues to evolve rapidly with increasing medical device connectivity and an increased frequency and severity of cybersecurity threats to the healthcare sector1. Cybersecurity threats that target medical devices can render medical devices and hospital…
Guidance has been drafted1,2 to selectively update the 2023 guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, to reflect changes introduced by section 524B of the Federal Food, Drug, and Cosmetic Act (FFD&C Act).…
The Cybersecurity and Infrastructure Security Agency (CISA) has issued a notice of proposed rulemaking that, if finalised, would establish new mandatory cyber incident reporting requirements across various industries, including healthcare1. In the proposed rule, the CISA has defined which entities…
As part of its efforts to support device sponsors as they address cybersecurity concerns, the Food and Drug Administration (FDA) has fully recognised1 the key consensus standard ANSI/AAMI SW96:2023, Standard for medical device security – Security risk management for device…
On 22 November 2023, the Australian Government released its 2023–2030 Australian Cyber Security Strategy1. This Strategy is the roadmap that will be used to help realise the Government’s vision of becoming a world leader in cybersecurity by 2030. Through the…
The first edition of Technical Reference TR-007, Software Medical Devices and Cybersecurity, was issued on 29 December 2023 with immediate effect1. This document aims to provide an overview of, and definitions for, software developed for medical purposes, both software in…
Following consultation with industry, the Cyber Security Agency of Singapore (CSA) has launched a nine-month trial1 for participating medical device manufacturers to test out and provide feedback on the requirements and application processes for the Cybersecurity Labelling Scheme for Medical…
The Food and Drug Administration has finalised its guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions1,2. This guidance provides recommendations on medical device cybersecurity considerations and what information to include in pre-market submissions. It…
Introduction The global medical device market in 2022 was worth US$512.29 billion and is projected to grow to US$799.67 billion by 2030 at a compounded annual growth rate of 5.9%1. Much of the rapid growth of the medical device sector…
ANSI/AAMI SW96:2023, Standard for medical device security – Security risk management for device manufacturers1, provides specific requirements for managing security across the total medical device lifecycle. This standard is based on guidance previously published in: AAMI TIR57:2016/(R)2023, Principles for…
As a general rule, the Food and Drug Administration (FDA) does not intend to issue refuse to accept (RTA) decisions for pre-market submissions for cyber devices submitted before 1 October 2023 based solely on information required by the new amendments…
In April 2023, the International Medical Device Regulators Forum (IMDRF) published two documents concerning the cybersecurity of medical devices. IMDRF/CYBER WG/N73, Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity1, provides a high-level description of a software…
ISO/IEC 27001:2022, Information security, cybersecurity and privacy protection – Information security management systems – Requirements, was published on 25 October 20221. This 19-page document specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within…
The Cyber Security Agency of Singapore, in collaboration with the Ministry of Health, Health Sciences Authority (HSA) and Integrated Health Information Systems, has developed a new Cybersecurity Labelling Scheme for Medical Devices (CLS (MD)). Under the CLS (MD), medical devices…
The European Association of Medical Devices Notified Bodies (Team-NB) has recently released several Position Papers to help standardise the approaches taken by Notified Bodies in an effort to improve efficiency and provide more certainty to both Notified Bodies and industry:…
In September 2022, a document entitled Cybersecurity of medical device software1 was drafted within the framework of the National Agency for the Safety of Medicines and Health Products’ (ANSM’s) Temporary Specialised Scientific Committee. The purpose of this document is to…
Interested parties have until 30 August 2022 to submit comments on the International Medical Device Regulators Forum’s (IMDRF’s) Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity1. This draft document provides recommendations for stakeholders, including medical device…
Introduction Connectivity is increasingly a standard feature of medical devices. The significant benefit that connectivity brings also comes with challenges, notably around cybersecurity. The transition to fully networked and connected equipment allows innovative new ways of diagnosing, monitoring and treating…
New guidance has been issued, based on the recommendations of the International Medical Device Regulators Forum, for ensuring and thoroughly enforcing the cybersecurity of medical devices1. The guidance replaces the former guidance from 2008 and updates the technical requirements to…
On 8 April 2022, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions – Draft Guidance for Industry and Food and Drug Administration Staff was released for public comment1,2. This guidance is intended to provide recommendations to…
The China Food and Drug Administration has published a number of guiding principles for the technical review of the security of networked medical devices as part of the device’s registration process1. This guidance is expected to enter into force on…
A new Office of Digital Transformation has been established within the Food and Drug Administration (FDA) to oversee the Agency’s information technology, data management and cybersecurity functions1. The Office reports directly to the FDA Commissioner, elevating these functions to Agency…
Interested parties have until 17 August 2021 to put forward their comments on a Food and Drug Administration discussion paper entitled Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities1. This discussion paper considers cybersecurity issues that…
The Center for Devices and Radiological Health (CDRH) has issued a response1 to the National Institute of Standards and Technology (NIST) regarding the President’s Executive Order on improving cybersecurity in the Federal Government (EO 14028)2. The response highlights existing Food…
New guidance has been developed to assist industry in ensuring the cybersecurity of medical devices by highlighting cybersecurity-related issues that should be considered by manufacturers during product design, research and development, applications for inspection and registration, and in the post-market…
The National Health Surveillance Agency (ANVISA) has published a 45-page guide on the Principles and Practices of Cybersecurity in Medical Devices (Guide No. 38, version 1) and is accepting comments on the guide until 23 March 20211. The guide is…
Comments were accepted until 19 October 2020 on the Guiding Principles for Technical Review of Medical Device Cybersecurity (Second Edition)1. This draft guideline applies to the registration and application of medical device network security systems, including Class II and Class…
In late April 2020, the International Medical Device Regulators Forum (IMDRF) published its first guidance document focusing exclusively on medical device cybersecurity, including in vitro diagnostic medical devices1. The guidance provides an overview of the general principles of medical device…
New Guidelines for Network Security of Medical Equipment for Manufacturing Plants1 have been published in an effort to ensure the cybersecurity of medical devices and their manufacturing facilities. The guidelines recommend that every manufacturing plant should consider cybersecurity-related matters at…
Comments are being accepted until 2 December 2019 on the draft Principles and Practices for Medical Device Cybersecurity, which have been developed by the International Medical Device Regulators Forum (IMDRF)1. This draft document sets out fundamental recommendations to all stakeholders…
During May 2019, three draft guidance documents related to medical device cybersecurity were released for public viewing: Project on Guidance to Pre-Market Cybersecurity of Medical Devices1 This guidance has been designed to help industry identify cybersecurity issues that manufacturers…
The Therapeutic Goods Administration (TGA) has released a guidance document for industry on medical device cybersecurity1 to help manufacturers and sponsors understand how the TGA interprets the regulations, and thus indicate how to comply. The recommendations contained in the cybersecurity…
Health Canada has published a guidance document on the pre-market requirements for medical device cybersecurity in an effort to better protect patient safety1. The new requirements in the guidance, which came into force immediately, describe how and when to implement…
A period of public consultation is being held until 30 September 2019 on draft recommendations for manufacturers of medical devices integrating software to ensure that cybersecurity is taken into account during product development to minimise the risk of cyber-attacks1. This…
Regulatory guidance on cybersecurity for medical devices has been drafted in line with existing regulatory requirements, and comments on the draft text are being accepted until 14 February 20191. The draft guidance is divided into two main sections, providing advice to: …
Stakeholder feedback has been sought on technical considerations for the cybersecurity of medical devices and the pre-market submission requirements for a medical device licence1. The draft guidance document provides device manufacturers with advice on the practices, responses and mitigation measures…
Comments are being accepted until 18 March 2019 on a draft guidance document entitled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices1,2. Although the Food and Drug Administration issued guidance in 2014 that set out recommendations for…
