October Medical Device Regulatory Updates

21st October 2024 – MHRA Unveils Draft PMS SI, First Major Update

• Findings from the 2020 Independent Medicines and Medical Devices Safety Review highlighted gaps in UK post-market surveillance regulations.
• The new Statutory Instrument aims to enhance patient safety, device traceability, and international alignment.
• Implementation period: six months – the regulation could become law by Summer 2025.
• Further manufacturer guidance will be published after the implementation phase.

16th October 2024 – UK Government Releases ‘Design for Life’ Strategy for Sustainability

• The UK plans to phase out avoidable single-use medical devices by 2045.
• Identified challenges:
  • • Over-reliance on single-use products.
    • Outdated regulations.
    • Lack of market infrastructure for reuse/recycling.
• Aims to boost UK-based manufacturing, cut reliance on imports, and support the Net Zero NHS.

14th October 2024 – £4.2 Million Fund for MedTech SMEs Launched

• MedTech Accelerator: Rapid Regulatory Support Fund (MARRS) opened for applications on 9th October.
• SMEs could apply for grants up to £30,000 to fund regulatory support.
• Demand was high, with 300 applications reaching the program’s limit.

8th October 2024 – Regulatory Innovation Office (RIO) Launched

• Supports businesses and regulators in handling innovative medical devices.
• Focus areas include AI and digital healthcare.
• Works to reduce regulatory barriers and enhance government oversight.

7th October 2024 – MHRA Releases 2024/25 Business Plan

• Strategic Priorities:
  • • Improve public trust through transparency.
    • Ensure safe healthcare access.
    • Advance scientific and regulatory excellence.
    • Foster an efficient and customer-focused agency.
• Introduces new regulatory IT systems: SafetyConnect and RegulatoryConnect.

1st October 2024 – Breakthrough in Orthopaedic Surgery with New Drill Guidance System (DGS)

• First use of a groundbreaking device for orthopaedic surgery at Royal United Hospital in Bath.
• Expected benefits:
• • • Reduced X-ray exposure.
    • Lower risk of infection.
    • Improved surgical precision.

30th October 2024 – FDA Sterilization Town Hall Focuses on Reducing Ethylene Oxide Use

• Discussed new sterilization alternatives and small business funding options.
• Next session: 20th November 2024.

23rd October 2024 – FDA Appoints Dr. Michelle Tarver as New Director of CDRH

• Dr. Tarver replaces Dr. Jeffrey Shuren as Director of the Center for Devices and Radiological Health.
• Focuses on improving transparency and patient education about device risks/benefits.

18th October 2024 – FDA Extends Public Comment Period for ASCA Guidance

• New deadline: 23rd December 2024.
• Covers Accreditation Scheme for Conformity Assessment (ASCA) updates.

15th October 2024 – CDRH Launches Device Trial Participation Snapshots

• Provides clinical trial data on approved medical devices.
• Aims to increase transparency and encourage patient participation in trials.

10th October 2024 – CDRH Publishes 2025 Proposed Guidance List

• Priority topics include:

• • • Cybersecurity in medical devices.
    • IVD policies for public health emergencies.
    • Feedback process for medical device submissions.

1st October 2024 – TAP Pilot Expands to More Medical Device Sectors

• The Total Product Life Cycle (TPLC) Advisory Program now includes:
• • • Ophthalmic Devices.
    • Radiological Health.
    • Cardiovascular and Neurological Devices.

29th October 2024 – MDCG Releases Updated Guidance on Borderline Products

• Clarifies whether certain products fall under MDR or MPD (Medicinal Products Directive).
• Now includes products used for cleaning, disinfection, and sterilization of medical devices.

• 29th October 2024 – MDCG Issues Guidance on Ethylene Oxide (EtO) Use in Medical Device Sterilization

• Clarifies EtO’s regulatory status in single-use medical device manufacturing and in-house sterilization for reusable devices.
• Confirms that EtO processes fall under MDR/IVDR conformity assessment requirements.

23rd October 2024 – MEPs Debate MDR/IVDR Implementation Strategy

• Discussion over fast-tracking implementation vs. ensuring a thorough, systematic review.
• Calls for targeted impact assessments of the regulations before full implementation.

16th October 2024 – MDCG Revises Guidance on Legacy Devices (MDCG 2021-25 rev.1)

• Clarifies MDR requirements for legacy devices certified under 90/285/EEC or 93/42/EEC.

October 2024 – MDCG Meetings on Medical Device Regulation

• Key topics discussed:
  • • MDR/IVDR rollout.
    • EUDAMED progress.
    • Notified Body (NB) oversight.
    • PMS & vigilance strategies.

9th October 2024 – EU Publishes Updated Standards on Aseptic Processing

• Aligns EN ISO 13408-1:2015 with MDR/IVDR requirements for sterilization standards.

8th October 2024 – MDCG Releases New Guidance on IVD Qualification (MDCG 2024-11)

• Provides a clear framework for classifying IVD medical devices and their accessories.

7th October 2024 – New MDCG Guidance on CAPA Plan Assessments (MDCG 2024-12)

• Standardized Corrective and Preventive Action (CAPA) plans for Notified Bodies and Competent Authorities.