June Medical Device Regulatory Updates

13th June 2024: MHRA, FDA, and Health Canada Release Joint Guidance on Transparency in Machine Learning-Enabled Devices

• Builds on the 2021 Good Machine Learning Practice (GMLP) principles.
• Focuses on transparency in how AI-driven medical devices are described and understood.
• Expands on principles related to human-AI team performance and providing clear information to users.
• Encourages consideration of key factors such as purpose, usage, and audience understanding.

19-21st June 2024: UK HealthTech Showcased at Florida International Medical Expo

• Six UK startups participated in the event, demonstrating innovations in imaging, patient handling, waste disposal, surgical instruments, and diagnostics.
• Highlights the UK’s position in medical device and digital health innovation.

24th June 2024: First UK Patients Receive Acid Reflux Implant

• University Hospital Southampton and Imperial College London collaborated on robotic implantation of the RefluxStop device.
• Designed for patients with severe gastro-oesophageal reflux disease (GORD).
• The non-active implant is laparoscopically affixed to the stomach to prevent acid reflux.
• Clinical trials indicate normalisation of stomach acid levels and positive patient outcomes.

24th June 2024: UK Teen Becomes First in the World to Receive Epilepsy Brain Implant

• A Picostim neurotransmitter, developed by UK company Amber Therapeutics, was implanted in a trial at Great Ormond Street Hospital.
• The patient, who previously experienced 20-200 seizures per day, has seen an 80% reduction in seizure activity.
• The trial is a collaboration between University College London, King’s College Hospital, and the University of Oxford.

14th June 2024: FDA Expands Recall of Chinese-Made Syringes

• Recall initiated by Merit Medical Systems for Jiangsu Shenli syringes due to quality system failures.
• Reports of leakage, breakage, incorrect dosage delivery, and dimensional inconsistencies.
• FDA continues inspections, testing, and detainment of affected products.

17th June 2024: FDA Encourages COVID-19 Test Developers to Pursue Traditional Market Approval

• Transitioning from emergency use authorisation (EUA) to full regulatory approval.
• Tests approved through traditional pathways can be used beyond EUA time limits.
• The FDA remains committed to expanding access to reliable COVID-19 tests.

27th June 2024: FDA Releases Guidance on Diversity in Clinical Trials

• Manufacturers conducting clinical trials must submit Diversity Action Plans (DAPs).
• Aims to increase enrollment of underrepresented populations.
• Expected to improve the reliability and applicability of clinical trial data.

17th June 2024: MDCG Updates Guidance on Notified Body and Conformity Assessment Processes

• Covers designation, reassessment, and notification of Notified Bodies (NBs) and Conformity Assessment Bodies (CABs).
• Ensures consistency in assessment and oversight under MDR and IVDR regulations.

18th June 2024: EU Updates Guidance on Phthalates in Medical Devices

• Focuses on phthalates that are carcinogenic, mutagenic, toxic to reproduction (CMR), or endocrine-disrupting (ED).
• Updates reflect five years of scientific opinions and ongoing regulatory surveillance.
• Phthalates are widely used as plasticisers in medical device manufacturing.

25th June 2024: New Guidance on Clinical Evaluation of Orphan Devices

• Orphan devices serve rare disease patients with unmet clinical needs.
• Developed by the Medical Device Coordination Group (MDCG) to support manufacturers in meeting MDR clinical evidence requirements.
• Recommended for use alongside other MDCG guidance documents.