September Medical Device Regulatory Updates

26th September 2024: MHRA Updates Guidance on Clinical Investigations

• Manufacturers conducting clinical investigations as part of device certification must notify the MHRA at least 60 days in advance.
• The updated guidance includes details on application processes, fees, event reporting, and IVD-specific updates.
• Applications can be submitted via the Integrated Research Application System.

25th September 2024: MHRA Resumes External Engagement on Regulatory Changes

• The UK MDR 2002 is being updated through statutory instruments, starting with post-market surveillance rules.
• A ‘pre-market’ statutory instrument will follow, focusing on improving patient safety and access.
• MHRA is working with the IMDRF to align regulations internationally.

23rd September 2024: AI Airlock Application Process Closing Soon

• The AI Airlock is a regulatory sandbox for AI-driven medical devices.
• The program will identify and address challenges in AI medical device regulation while ensuring safety.
• Eligible devices must demonstrate novelty, NHS benefit, and regulatory complexity.

18th September 2024: MHRA Publishes Data Strategy (2024-2027)

• Strategy focuses on big data, AI, and real-world evidence in medical device regulation.
• Aims to create internationally recognized regulatory decisions for medical devices.

30th September 2024: FDA Commissioner Calls for Mandatory Reporting of Medical Device Shortages

• Currently voluntary, but Commissioner Robert Califf advocates for mandatory reporting to prevent supply chain crises.
• Emphasizes supporting domestic medical device production.
• 20th September 2024: FDA Releases Draft Guidance on Biocompatibility Assessment
• Manufacturers must conduct chemical analysis as part of biocompatibility risk assessments.
• Helps identify and mitigate safety risks before product approval.

20th September 2024: FDA Issues Guidance Following Completion of ASCA Pilot Program

• The Accreditation Scheme for Conformity Assessment (ASCA) is now fully operational.
• New guidance clarifies:
• Safety and performance of electrical medical equipment.
• Biocompatibility testing standards.

17th September 2024: FDA Announces Public Advisory Meeting on AI Device Lifecycle

• Meeting on 20-21 November 2024 in Gaithersburg, USA.
• Public comments accepted until 1st November 2024.

6th September 2024: FDA Updates List of AR/VR Medical Devices

• 69 augmented/virtual reality (AR/VR) medical devices now FDA-approved.
• Uses include surgical guidance, PTSD treatment, and stroke rehabilitation.

26th September 2024: Legacy Device Certification Deadline Passed

• Manufacturers must have a written agreement with a Notified Body to continue applying for MDR CE certification.
• Applications should have been submitted by 26th May 2024.

17th September 2024: EU Opens Public Consultation on Animal Testing

• The European Commission is gathering feedback on phasing out animal testing in chemical safety assessments.
• Consultation is open until 15th October 2024.

16th September 2024: Team-NB Updates Code of Conduct for Notified Bodies

• Version 5 introduces:
  • • Removal of outdated directives.
    • Stronger compliance with MDCG guidance.
    • Clearer timelines for technical documentation review and re-certification.
    • New rules on unannounced audits and Corrective & Preventive Action (CAPA).
• Encourages “Structured Dialogue” between manufacturers and Notified Bodies to improve efficiency.

11th September 2024: Team-NB Publishes Template for Surveillance Transfer Agreements

• Facilitates the transfer of surveillance responsibility from one Notified Body to another under EU 2024/1860.

September 2024: MDCG Updates Guidance on Class D IVD Certification

• EU Reference Laboratories (EURLs) will oversee class D in vitro diagnostic devices (IVDs) from 1st October 2024.

2nd September 2024: EU Releases Legislative Paper on AI Act

• Discusses implications, stakeholder feedback, and policy debates following the AI Act’s implementation in August 2024.