November Medical Device Regulatory Updates

14th October 2024 – MHRA Launches Consultation on Regulatory Reform

• Focus: Strengthening UK medical device regulations to improve patient safety and access.
• Key areas for feedback:

• • • UKCA marking.
    • International reliance.
    • IVD classification.
    • Assimilated EU law.
• Consultation closes: 5th January 2025.

19th November 2024 – New Chair of MHRA Appointed

• Professor Anthony Harnden (Oxford University, Primary Care) replaces outgoing Chair.
• Previous roles: Deputy Chair of the Joint Committee on Vaccination and Immunisation (JCVI).
• Focus: Strengthening patient safety, regulatory oversight, and public trust.

25th November 2024 – Welsh AI Firm Secures Funding for Home Healthcare Devices

• Laennec AI Limited secured funding from SFC Capital and OVC Ventures.
• Developing AI-powered home monitoring devices to allow remote clinician oversight.
• Goal: Early detection, continuous monitoring, and patient-led disease management.

29th November 2024 – Assisted Dying Bill Passes Initial Vote in Parliament

• MPs voted in favour of the Terminally Ill Adults (End of Life) Bill by 55 votes.
• If passed in 2025, adults with less than six months to live may legally end their lives.
• Dr Philip Nitschke aims to bring his “Sarco” assisted suicide pods to the UK pending legislation.

25th November 2024 – FDA Issues Temporary Discretion Policy on EtO Sterilization

• Background: The EPA restricted EtO use due to carcinogenic risks.
• FDA Response: Allows temporary discretion for Class III devices sterilized with EtO to prevent supply shortages.
• Manufacturers must submit informal notifications to request enforcement discretion.

20-21st November 2024 – FDA Advisory Committee Discusses AI in Medical Devices

• Focus: Total Product Lifecycle for Generative AI-Enabled Devices.
• Key Topics:
  • • Pre-market performance evaluation.
    • AI risk mitigation strategies.
    • Regulating AI devices’ continuous updates.

21st November 2024 – FDA Finalizes Third-Party 510(k) Review Guidance

• Seven organizations now authorized to conduct third-party 510(k) reviews.
• Goal: Speed up low to moderate risk device approvals while focusing FDA resources on complex submissions.

21st November 2024 – FDA Launches Pilot Program on Medical Device Recalls

Goal: Improve communication timelines for high-risk device recalls.

• Triggered by: Advisory committee recommendations to improve public safety.

25th November 2024 – FDA Commissioner to Be Replaced Following Trump’s Election

• Dr. Marty Makary nominated to replace Robert Califf as FDA Commissioner.
• Makary is a critic of the FDA’s handling of COVID-19 and has called for regulatory reforms.
• Leadership shift expected to bring major policy changes in 2025.

6th November 2024 – NB Survey Shows Improvement in MDR/IVDR Progress

• Survey by European Commission’s DG SANTE found an increase in Notified Body (NB) applications and certifications.
• Concerns remain: Long processing times, low-quality submissions, and high application rejection rates.

11th November 2024 – MDCG Updates Guidance on Vigilance Terms

• MDCG 2023-3 rev.1 adds four new Q&A addressing:

• • • Indirect harm in IVD use.
    • Definition of “expected erroneous results”.
    • Serious incidents during clinical trials.
    • Corrective action reporting to authorities.

21st November 2024 – EUDAMED Rollout Q&A Released

• Clarifies:

• • • Mandatory registration deadlines for manufacturers.
    • UDI/device registration requirements.
    • Roles of Notified Bodies and regulators.

26th November 2024 – MDCG Issues Master UDI-DI Guidance for Contact Lenses

• Grouping method established for contact lenses under a Master UDI-DI instead of individual UDI-DIs.
• Grouping factors: Base curve and diameter of lenses.