December Medical Device Regulatory Updates

4th December 2024 – AI Airlock Update: Five AI-Enabled Devices Selected

• AI Airlock, the UK’s first regulatory sandbox for AI medical devices, selected five cutting-edge technologies:
• Lenus Stratify (Lenus Health) – AI-driven COPD risk prediction.
• Existing Radiology Systems (Philips) – AI-integrated radiology reporting.
• FAMOS (Newton’s Tree) – Real-time AI performance monitoring.
• OncoFlow (UMA Advisory) – Cancer treatment planning AI.
• SmartGuideline (Automedica) – AI-powered healthcare knowledge database.
• Part of the UK’s 10-year digital health strategy.

6th December 2024 – Revised Regulatory Reform Roadmap Released

• Key updates:
• PMS Regulations effective 16th June 2025.
• Extended CE mark acceptance:
• Medical Devices – until 30th June 2028.
• IVDs – until 30th June 2030.
• Pre-market regulations coming in 2025 and 2026.
• New AI & digital health guidance expected, covering cybersecurity, AI development, and Good Machine Learning Practice (GMLP).

12th December 2024 – New Clinical Trials Legislation Laid in Parliament

Goals:

• Reduce administrative burdens on sponsors.
• Encourage internationally aligned clinical trial standards.
• Streamline MHRA processing times.

Key focus areas:

• Public health and participant safety.
• Efficient evaluation of life-changing medicines.

16th December 2024 – PMS SI Becomes Law

• The Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024 is now legally binding.

New obligations for manufacturers:

• Enhanced data collection and shorter incident reporting times.
• Mandatory Post-Market Surveillance (PMS) Plans.
• Stronger patient and public engagement requirements.
• Periodic Safety Update Reports (PSURs) now required.

3rd December 2024 – FDA Issues Guidance on AI Change Control Plans

• Predetermined Change Control Plan (PCCP) now required for AI-enabled medical devices.

Manufacturers must document:

• Planned AI modifications.
• Risk assessments and ongoing performance monitoring.

4th December 2024 – Latest FDA Sterilization Town Hall

Key discussions:

• Transition away from ethylene oxide (EtO) sterilization.
• Use of vaporized hydrogen peroxide for sterilization.

17th December 2024 – FDA Releases GUDID Guidance

Global Unique Device Identification Database (GUDID) updated to improve:

• Device traceability and recall efficiency.
• Global harmonization of medical device tracking.

20th December 2024 – FDA Releases Clinical Decision Support (CDS) Software FAQs

• Clarifies when CDS software is classified as a medical device
• Essential for manufacturers assessing regulatory obligations.

30th December 2024 – FDA Unveils ‘Home as a Healthcare Hub’ Initiative

• New “Idea Lab” launched to explore medical device use in home settings.
• Aims to enhance home healthcare solutions amid rising demand for remote patient monitoring.

2nd December 2024 – MDCG 2024-15 Released: Clinical Investigation Reporting

Guidance for manufacturers on reporting clinical investigations in the absence of EUDAMED.

Requirements:

• Reports must be submitted within 12 months of study completion.
• Immediate public access to reports via national authorities.

6th December 2024 – MDCG 2024-16: Supply Chain Disruptions Reporting

• New obligations for manufacturers to report interruptions in supply.
• Applies to devices where shortages could cause serious patient harm.

12th December 2024 – European Commission Opens Public Consultation on Medical Device Regulations

Focus:

• Effectiveness and impact of MDR/IVDR.
• Associated costs and regulatory burden.
• Feedback open until 21st March 2025.

18th December 2024 – MDCG 2022-3 Rev 1: Updates to Class D IVD Verification

• Clarifications on batch testing, direct manufacturer agreements with EU Reference Labs, and revised risk classification for calibrators and controls.

• Q&A on Medical Device Supply Interruption

• Mandatory reporting of supply chain disruptions begins 10th January 2025.

• Economic operators must relay supply warnings to health institutions and professionals.