January 2024 Medical Device Regulatory Updates

1. 9th January 2024: Regulatory Roadmap for Medical Technologies

• The MHRA announced plans for new regulations focused on medical technologies, including AI and diagnostics.
• The roadmap aims to enhance patient safety and ensure timely access to innovative healthcare solutions by 2025.

2. 16th January 2024: Updates to MHRA Guidance

• Clinical investigations for medical devices must be notified to the MHRA at least 60 days in advance.
• New fees introduced in April 2023; invoices are issued upon receipt of a valid application.

3. 31st January 2024: New UK Approved Bodies for Medical Device Certification

• LNE-GMED UK and Scarlet NB UK designated as UK Approved Bodies.
• Expands certification capacity, benefiting healthcare professionals and patients.
• UL International UK and TÜV SÜD also expanding their certification scope.

1. 10th January 2024: FDA Town Hall on Medical Device Sterilization

• The FDA is working to reduce reliance on ethylene oxide (EtO) sterilization while maintaining supply chain integrity.
• Strategies include regulatory flexibility, collaboration, and innovation.

2. 12th January 2024: Mammography Quality Standards Act (MQSA) Final Rule Update

• The final rule amending MQSA regulations must be implemented by September 10, 2024.
• Guidance provided to help facilities prepare for inspections.

3. 26th January 2024: Second FDA Town Hall on Medical Device Sterilization

• Focus on ensuring U.S. sterilization capacity and reducing EtO use.
• FDA introduced an EtO Tiger Team to advance sterilization innovations.

4. 31st January 2024: Quality Management System Regulation (QMSR) Final Rule

• Updates CGMP requirements and aligns them with international ISO 13485 standards.
• Becomes effective on February 2, 2026; manufacturers must comply until then.

1. 1st January 2024: MDCG Guidance on Vigilance for CE-Marked Devices

• Updates to vigilance reporting for specific devices, including cardiac ablation devices and coronary stents.

2. 3rd January 2024: Cardiac Implantable Electronic Devices (CIEDs) Guidance Update

• New procedures for reporting incidents involving CIEDs.

3. 4th January 2024: Breast Implants Guidance Update

• Clarifications on vigilance reporting for breast implants.

4. 17th January 2024: Overview of Language Requirements for Medical Device Manufacturers

• Provides manufacturers with language requirements for device instructions across EU member states.

5. January 2024: Joint Implementation Plan for In Vitro Diagnostic Medical Devices (IVDR)

• Outlines regulatory priorities and monitoring measures to ensure compliance and patient safety.

6. 24th January 2024: IVDR Transition Period Extension Proposal

• High-risk in vitro diagnostic devices have until December 2027 to comply.
• Lower-risk devices have a transition period until December 2029.