June Medical Device Regulatory Updates
United Kingdom 2024
Medical Device Updates
13th June 2024 – MHRA, FDA and Health Canada release jointly established guidance on transparency in machine learning-enabled medical devices
✓ This builds on the 10 guiding principles identified by the group in 2021 for Good Machine Learning Practice (GMLP). The focus of the original 10 guiding principles was on safe, effective, high-quality use of artificial intelligence/machine learning technologies.
✓ The six new guiding principles particularly build on the original principle 7 (Focus is placed on the performance of the human-AI team) and principle 9 (users are provided clear, essential information).
✓ ‘Transparency’ in the new guidance refers to how clearly the machine learning-enable medical device is described and therefore understood to audiences.
✓ The new guiding principles encourage consideration of the ‘who’, ‘why’, ‘what’, ‘where’, ‘when’ and ‘how’ of the ML-enabled device.
Source: Machine learning medical devices: transparency principles – GOV.UK (www.gov.uk), transparency_ml-enabled_devices_guiding_principles.pdf (publishing.service.gov.uk)
✓ The latest UK innovation in medical devices, diagnostics and digital health technologies was showcased at the annual event in Florida.
✓ The exhibitors involved included Biotronics 3D Limited (next generation imaging platform), GBUK Group (user-friendly patient handling products/enteral feeding product range), Haigh Engineering (waste disposal solution), Huntleigh Healthcare (vascular/foetal/patient assessment, treatment and monitoring), Surtex Instruments (surgical precision instruments), Timesco Healthcare (difficult airway laryngoscopes).
✓ This event provided a global platform for these manufacturers to demonstrate the culture of visionary innovation in healthcare in the UK at the moment.
Source: Florida International Medical Expo (FIME) 2024 (abhi.org.uk), UK HealthTech takes centre stage at FIME 2024 with ABHI UK Pavilion – Medical Plastics News
✓ In collaboration with University Hospital Southampton and Imperial College London, manufacturer RefluxStop have robotically implanted the devices in patients suffering with gastro-oesophageal reflux disease.
✓ It is estimated that around 20% of the UK adult population experiences severe acid reflux disease. This is when the opening of the stomach, from the oesophagus doesn’t function as it should, and allows stomach acid to escape back up into the oesophagus, causing symptoms including pain, difficulty swallowing, bloating, nausea and sleep disturbance.
✓ The device has been CE marked since 2018, having demonstrated high levels of safety and effectiveness through clinical investigation.
✓ The device is a non-active implant that is affixed to the upper part of the stomach through laparoscopic surgery. Early post-surgical figures are very favourable, showing normalisation of stomach acid levels and positive feedback from patients.
Source: Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results – PMC (nih.gov), RefluxStop™ · RefluxUK
✓ The teenager, who can have 20 – 200 seizures in one day has experienced an 80% reduction in seizure activity since having the device fitted.
✓ The treatment is part of a trial ran by Great Ormond Street Hospital, in collaboration with University College London, King’s College hospital and the University of Oxford.
✓ The device is a Picostim neurotransmitter, manufactured by UK company Amber Therapeutics.
Source: Amber Therapeutics – Home (amber-tx.com), World first for epilepsy | A UK boy with severe epilepsy has become the first patient to trial a device fitted in the skull to control seizures. (neurotherapynetwork.org.uk)
United States 2024
Medical Device Updates
✓ Under guidance of the FDA, a recall initiated by Merit Medical Systems, Inc. is underway on Jiangsu Shenli syringes, including those found it kits.
✓ It advises that these syringes continue to fail to meet device quality system requirements.
✓ Increased inspections at manufacturer facilities, product examination and detainment at the border, laboratory testing and working with manufacturers to ensure correct action is underway, as well as encouragement of use of syringes from any country other than China is all within the FDA response.
✓ This is following increased reports of syringe failures including leakages, breakages, inability to deliver the correct doses and issues with syringe dimensions.
✓ These tests were initially only available under the emergency use authorisation (EUA) pathway.
✓ Gaining traditional marketing authorisation approval will allow these tests to be used outwith the time allowed by EUA.
✓ The FDA has also released guidance in relation to this “Transition Plan for Medical Devices Issued EUAs related to COVID-19” .
✓ The Center for Devices and Radiological Health (CDRH) states it remains committed to expanding access to safe and effective tests though the FDA’s traditional premarket review pathway.
SOURCE: COVID-19 Tests Granted Traditional Marketing Authorization by the FDA | FDA , download (fda.gov)
✓ Under the Federal Food, Drug & Cosmetic Act, endorsed by the Food and Drug Omnibus Reform Act of 2022, manufacturers conducting clinical trials have been expected to submit Diversity Action Plans (DAP).
✓ The aim of DAPs is to increase the enrolment of participants from underrepresented population groups. It is believed this will improve the reliability and robustness of clinical trials and make them more applicable for general use across the population.
Source: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies | FDA , download (fda.gov)
European Union 2024
Medical Device Updates
✓ The document is aimed at responsible authorities for notified bodies (NBs) and conformity assessment bodies (CABs).
✓ Assessment, designation and notification processes are underpinned by Articles 38 to 42 of the MDR and Articles 34 to 38 of the IVDR.
✓ This aims to bring consistency and continuity to the actions of the designating authorities responsible for ensuring these processes are fit for purpose.
✓ The updated guidance refers to the benefit-risk assessment of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) pr have endocrine-disrupting (ED) properties.
✓ SCHEER, or the Scientific Committee on Health, Environmental and Emerging Risks, released the original guidelines in 2019 and they have now been updated based on the scientific opinions of the committee and the ongoing surveillance in the last five years.
✓ Phthalates are a group of chemicals widely used in medical device manufacturing as plasticisers.
Source: 831f9b60-88de-4197-858f-d001c5b0cc26_en (europa.eu)
✓ Orphan devices are those which often fulfil unmet clinical needs in rare diseases or conditions affecting a small portion of the population.
✓ The guidance was developed by the MDCG (Medical Device Coordination Group).
✓ The guidance is intended to assist manufacturers in achieving the increased requirements for clinical evidence set out by the MDR.
✓ The MDCG recommends this guidance should be read in conjunction with other documents relating to medical devices, such as MDCG 2020-5, MCCG 2020-6 AND MDCG 2023-7.
Source: ec.europa.eu/newsroom/sante/newsletter-archives/54175, daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en (europa.eu)