March Medical Device Regulatory Updates

11th March 2024: MHRA Measures to Promote Equity in Medical Devices

• The MHRA is committed to:
  • • Providing guidance to manufacturers on improving diversity in testing, investigation, and development.
    • Engaging in discussions on AI and software as medical devices to ensure inclusive regulations.
    • Strengthening vigilance by involving patients and the public to maintain high protection levels.

11th March 2024: Government Action on Bias in Medical Devices

• New requirements:
  • • Medical device applications must address potential bias.
    • NHS guidance updated to highlight limitations of pulse oximeters for patients with dark skin.
    • Funding available for research into improved oximeters.
• Further government efforts:
  • • Collaborating with MHRA to ensure device regulations are safe for all patients.
    • Addressing racial bias in data collection.
    • Supporting NHS England in training personnel on health equity.
    • Improving transparency in AI-driven medical devices.

11th March 2024: Webinars on UKCA and CE Markings

• Webinars scheduled for:
  • • 21st March 2024 at 3 PM
    • 26th March 2024 at 2 PM
    • 15th April 2024 at 3 PM
    • 29th April 2024 at 3 PM

25th March 2024: MHRA Warning on Counterfeit LifeVac Anti-Choking Devices

• Over 10,000 counterfeit devices estimated to be in circulation.
• Advice to the public:
  • • Purchase only from reputable sellers.
    • Ensure devices have UKCA or CE markings.
    • Verify registration with MHRA via the public access database.
    • Be cautious of devices manufactured in China, as none are registered with the MHRA.
• The MHRA is working to remove counterfeit anti-choking devices from online marketplaces.

22nd March 2024: FDA Updates Breakthrough Devices Program

• The program accelerates approval for innovative devices treating serious conditions.
• Updates include:
  • • Addition of Device Designations Data and Market Authorizations list.
    • Prioritized review for manufacturers in the program.
    • Requirement for Breakthrough designation requests before marketing submission.
    • FDA response within 60 days on approval or denial of designation.

29th March 2024: First-of-Its-Kind Skin Harvesting System Approved

• The Medline Autologous Regeneration of Tissue (ART) System enables:
  • • Harvesting and grafting of small plugs of healthy skin under local anesthesia.
    • Less invasive treatment in a wider range of healthcare settings.
• Medline aims to balance clinical and financial success with lower costs and better outcomes.

22nd March 2024: EU Introduces Language Requirement Tables

• Two new tables (for MDR and IVDR) provide an overview of language requirements per country.
• Aims to help medical device manufacturers, particularly small and medium-sized businesses, understand language rules for device instructions.
• Covers language requirements for graphical user interfaces (GUIs) in apps.

12th March 2024: New Guidance on Clinical Investigation Plans

• The Medical Device Coordination Group (MDCG) issued guidance on Clinical Investigation Plans for medical devices.
• Based on MDR and ISO 14155:2020 standards.
• While not mandatory, it is strongly recommended for best practice.
• Developed with input from national competent authorities, industry, and stakeholders.
• Helps companies structure their clinical investigation plans to meet regulatory assessment criteria.