February 2024 Medical Device Regulatory Updates

8th February 2024: Update – Regulation of Medical Devices in the UK

• Guidance covers certification, conformity marking, and MHRA registration.
• The fee per application for registering a new medical device or making changes has increased to £240.

26th February 2024: Update – Access Consortium

• The MHRA is part of the Access Consortium alongside regulatory bodies from Canada, Singapore, Switzerland, and Australia.
• Goals:
  • • Maximise international cooperation.
    • Reduce duplication.
    • Increase regulatory capacity for safe and effective therapeutic products.
• The update revises the terms of reference for the consortium as of November 2023.

29th February 2024: Update – Innovative Devices Access Pathway (IDAP)

• IDAP pilot helps bring new medical technologies into the NHS.
• Focuses on enabling patient access to innovative medical devices.
• Update includes Data Protection and Privacy information for the pilot phase.

1st February 2024: FDA Final Rule – Quality System Regulations Amendments

• Aligns FDA regulations with international standards.
• Modernises and harmonises regulations.
• Effective from 2nd February 2026.

7th February 2024: Third FDA Town Hall on Medical Device Sterilization

• Covered expectations for premarket submissions based on the updated 510(k) Sterility Guidance.
• Discussed sterilisation categories and submission considerations.

21st February 2024: Medical Device User Fee Reduction for Small Businesses

• FDA issued draft guidance to update small business qualification and certification criteria.
• Aims to adjust fees based on financial hardships for small businesses.

29th February 2024: Fourth FDA Town Hall on Medical Device Sterilization

• Introduced the use of “Modifications” guidance for 510(k) submissions and PMA decision-making.
• Explained Device Master Files (MAFs) and the differences between the traditional MAF process and the Sterility MAFs Pilot Program.

6th February 2024: MDCG – Updates to European Medical Device Nomenclature (EMDN)

• Annual revision procedures for:
  • • European Medical Device Nomenclature (EMDN).
    • Medical Device Regulation (MDR).
    • In Vitro Diagnostic Medical Devices Regulation (IVDR).
• Updates based on user feedback and practical use.

6th February 2024: MDCG – Guidance on Vigilance System for CE-Marked Devices

• Updates to vigilance reporting for specific devices.
• Clarifies procedures for reporting incidents to the relevant Competent Authority.

22nd February 2024: Second Call for EU Reference Laboratories for High-Risk In Vitro Diagnostic Devices

• In 2022, the European Commission designated five reference laboratories but lacked suitable applicants for four categories.
• A second call allows interested laboratories to apply until 30th April 2024.
• Requirements:
• • • Highly qualified staff.
    • Necessary equipment.
    • Knowledge of standards.
    • Independence.