May Medical Device Regulatory Updates
United Kingdom 2024
Medical Device Updates
21 May 2024 – MHRA issues statement of policy intent on recognition of international medical devices
✓ Government response to the 2021 consultation on the future regulations of medical devices in the UK. The MHRA now recognises the expertise and decision-making of regulatory partners in approving devices as safe for use.
✓ The MHRA intends with this to maintain patient safety and ensure the UK remains an attractive market for medical device innovators. It is also intended that this framework would reduce device assessment duplications, which could mean more timely access to innovative devices for UK patients.
✓ Type 1 Diabetics ordinarily must manually record their blood glucose levels and manage
them by injecting themselves with insulin as they require it. This device could eradicate
the need to do this.
✓ These regulatory partners or ‘comparable regulator countries (CRCs)’ will include – Australia (Therapeutic Goods Administration (TGA), Canada (Health Canada), European Union and the USA (FDA).
✓ The framework would provide a certificate of international recognition that would give access to the GB market but would not provide UKCA marking.
✓ Classification of the medical device under the UK MDR may not be the same as the classification under the CRC and the manufacturer must determine this. The MHRA held a webinar to guide manufacturers in this area (see source material).
✓ The MHRA are continuing to review potential comparable regulator countries, including Japan and Singapore.
Source: Statement of policy intent: international recognition of medical devices – GOV.UK (www.gov.uk), MHRA MedTech Regulatory Reform Webinar – 5 March 2024 – YouTube, MHRA explores new framework for international medical device recognition | UK Healthcare News (nationalhealthexecutive.com)
✓ Sensinel by Analog Devices is a wearable, at home device, which captures cardiopulmonary measurements which are then remotely sent to a clinician to review. The device aims to improve the lives of people with chronic disease, such as heart failure in this instance. The aim is to reduce emergency department attendance and hospital admissions.
✓ The device is non-invasive, wearable, using multiple sensors to detect levels of fluid accumulation in the body, which will affect the ability of the heart to pump blood around the body effectively. The study found the device was able to detect changes in fluid retention in heart failure patients, an occurrence which often leads to repeated hospital admission for fluid management to reduce the load on the heart.
✓ The study found the device could be useful in treating patients in the community, providing intervention such as early adjustment of medication as opposed to retrospective admission to hospital.
✓ Introduced to address potential challenges in the regulation of devices that incorporate Artificial Intelligence.
✓ While it is recognised that AIaMD (AI as a medical device) has the potential to revolutionise healthcare as we know it and improve patient outcomes, the MHRA is looking to adopt a balanced approach as it recognises there are also lots of challenges and potential safety concerns that need to be addressed in order to maximise patient safety
✓ 5 key principles proposed in the regulatory use of AI as a medical device (AIaMD); – Safety, security, and robustness; – Appropriate transparency and explainability; – Fairness; – Accountability and governance; – Contestability and redress.
✓ A webinar is to be held on the 23 July 2024 to inform about this project (see link for details).
Source: Software and AI as a Medical Device Change Programme – Roadmap – GOV.UK (www.gov.uk), AI Airlock – the Regulatory Sandbox for AIaMD in healthcare webinar Tickets, Tue, Jul 23, 2024 at 10:00 AM | Eventbrite, MHRA_Impact-of-AI-on-the-regulationof-medical-products.pdf (publishing.service.gov.uk)
United States 2024
Medical Device Updates
✓ The FDA has continued to evaluate plastic syringes produced in China and has added to the list of Chinese manufacturers whose syringes shouldn’t be used.
✓ The FDA advises problems found including leakages, breakage, and errors in how much liquid is administered from the affected syringes.
✓ The FDA are recommending use of syringes not made in China, if possible.
✓ They strongly encourage close monitoring of any Chinese-made syringes which do have to be used and to report any issues immediately.
✓ This follows an announcement by the American Government that they are raising taxes on a range of imported goods from China including syringes, needles, and surgical gloves.
Source: UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication | FDA, The White House hikes tariffs on plastic syringes made in China (statnews.com)
✓ The World Health Organisation (WHO) provides a list of regulatory bodies which are widely considered to be relied upon to meet the highest level of regulatory standards and practices for quality, safety and efficacy of products.
✓ Addition to this list is based on WHO performance evaluations of the regulatory authority in terms of their regulatory practices.
✓ The European Medicines Regulatory Network (EMRN) was also added to the list. The Health Sciences Authority (HAS) of Singapore, having already been designated as WLA, has been given an expanded scope of functions.
Source: Largest number of regulatory agencies for medical products approved as WHO Listed Authorities
✓ AiM Medical Robotics have announced collaboration with Brigham and Women’s Hospital (BWH) and Harvard’s Surgical Navigation and Robotics (SNR) lab.
✓ Aimed at patients with conditions such as Parkinson’s, Epilepsy and cancers affecting the brain.
✓ They have reported a successful cadaver trial which demonstrated the device’s ability to deliver precise deep brain stimulation leads using MRI guidance.
✓ AiM will develop a small, MRI-compatible surgical robot to assist clinicians during neurosurgeries.
✓ The hope is this device will reduce healthcare spending due to reduced errors and complications, as well as reducing surgery time by up to 50%.
✓ From August 2023 to the end of March 2024, 151 AI/ML-enabled devices (Artificial Intelligence and Machine Learning Enabled Medical Devices) were added to list of authorized devices
✓ The devices on the list have met the FDA’s applicable premarket requirements, including review of the overall safety and performance of the device, based on the intended use and technological characteristics.
✓ The FDA plans to update this list periodically
✓ The current list includes devices such as software platforms used for medical image analysis, devices used to count surgical items used in a theatre setting, and insertable cardiac monitoring systems which can transfer information about heart rhythms straight back to the responsible clinician.
European Union 2024
Medical Device Updates
✓ Leaders taking part in the MedTech Forum 2024 in Vienna, including the World Health Organization (WHO) and the European Commission (EC) warned the medical device sector to be aware of their own carbon footprint but also to be prepared for what climate change could mean for the future.
✓ Health industry impact due to increased mortality due to rising climate temperatures, as well as potential issues with their supply chains, were discussed.
✓ Hubert Gambs, the deputy director for small and medium enterprises at the European Commission, echoed the concerns of those who fear another health crisis linked to climate change – it is estimated due to the heat waves of 2022, there were 60-70,000 preventable deaths in Europe alone. Mr Gambs urged the sector to make itself more resilient by developing innovative solutions but urged innovators to consider sustainability in their designs
Source: About us – MedTech Europe, from diagnosis to cure, Medical device companies warned that ignoring climate change could spell disaster (yahoo.com), Medical device companies warned that ignoring climate change could spell disaster – Medical Device Network (medicaldevice-network.com)
✓ The new legislation is considered to be ground-breaking as it’s first of it’s kind. It is set to harmonise the rile on AI.
✓ The law applies to all 27 members of the EU any companies using EU customer data will also have to comply.
✓ Aims to safeguard the reliability, safety, efficacy, and equity of the population in relation to the use of AI
✓ Several new governing bodies will be set up in light of this new legislation, a central AI Office, a panel of independent scientific experts for consultation, an AI Board with representatives from member countries and an advisory forum for stakeholders to provide expertise.
✓ The European Medicines Regulatory Network (EMRN), which is composed of the European Commission, the European Medicines Agency (EMA) and the medicines regulatory authorities of 30 EU countries, has been added to the WHO Listed Authorities.
✓ The World Health Organisation (WHO) provides this list of regulatory bodies which are widely considered to be relied upon to meet the highest level of regulatory standards and practices for quality, safety and efficacy of products.
✓ Addition to this list is based on WHO performance evaluations of the regulatory authority in terms of their regulatory practices.
✓ The FDA (US Food and Drug Administration) was also added to the list. The Health Sciences Authority (HAS) of Singapore, having already been designated as WLA, has been given an expanded scope of functions.
Source: Largest number of regulatory agencies for medical products approved as WHO Listed Authorities
✓ TeltoHeart wristband, for which inception began in 2020, was deemed to be safe, effective and compliant with the EU MDR.
✓ The device detects atrial fibrillation by continuously monitoring the wearers heart rate, and also contains a high precision 6-lead ECG (electrocardiogram)
✓ The device is a ‘first of it’s kind’ product due to the combination of diagnostic features it possesses. The developer claims in has created ‘a new paradigm in wearable device diagnostics’.
Source: TeltoHeart wristband, developed by Lithuanian | EurekAlert!, TELTOHEART (teltonika-telemedic.com)
✓ Question-and-answer style revised document provides further guidance on medical devices and in vitro diagnostic devices which combine with medicinal products.
✓ The document provides information on a range of topics including lifecycle management of these products, packaging and labelling requirements, ancillary medical substances and companion diagnostics.
✓ This document is intended to support the EU MDR and EU IVDR regulations.
Source: Medical devices: new guidance for industry and notified bodies | European Medicines Agency (europa.eu), questionsanswers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pd
✓ A Preliminary Assessment Review (PAR) is a process used to assess a Notified Body’s documentation.
✓ This facilitates regulatory authorities in assessing the performance of Notified Bodies.
Source: HEALTH AND FOOD SAFETY – New MDCG 2024-6, 7, 8 and 9 as preliminary (re-)assessment review form templates for MDR and IVDR (europa.eu), Guidance – MDCG endorsed documents and other guidance – European Commission (europa.eu), mdcg_2024- 7_en_0.docx (live.com)