January Medical Device Regulatory Updates
United Kingdom 2024
Medical Device Updates
09th January 2024: Regulatory Roadmap Points Out New Measures to Support Safe Access to Medical Technologies (including AI and Diagnostics)
✓ The MHRA announced plans to develop new regulations specifically for medical technologies, emphasising patient safety and timely access to innovative healthcare solutions.
✓ The roadmap outlines priority measures and core elements intended to be in place by 2025, enhancing the UK’s position as a leader in medical technology innovation.
16th January 2024: Updates to MHRA guidance
The MHRA has updated guidance on how to notify them when there is an intention to carry out a clinical investigation for a medical device:
✓ It is now necessary to inform the MHRA at least 60 days prior to starting the investigation, which will be done through the Integrated Research Application System (IRAS)
✓ New fees associated with clinical investigation were introduced in April 2023. The MHRA will invoice the applicant upon receipt of a valid application.
31st January 2024: MHRA Announces Two New UK Approved Bodies for Medical Device Certification
✓ The MHRA designated two new UK Approved Bodies, LNE-GMED UK and Scarlet NB UK, to certify the performance and safety of medical devices.
✓ This announcement increases the capacity for the certification of medical devices in the UK, benefitting healthcare professionals and the public.
✓ The expansion of scope for existing UK Approved Bodies, including UL International UK and TÜV SÜD, further supports certification efforts.
United States 2024
Medical Device Updates
10th January 2024: FDA town hall on medical device sterilization
BACKGROUND: Ethylene oxide (EtO) is the most commonly used method to sterilize medical devices, a critical step in the manufacturing process for certain medical devices helps prevent serious infections and inadequate sterilization can lead to life-threatening infections.
The FDA is committed to reducing reliance on EtO sterilization use while ensuring the integrity of the supply chain so that patients and providers have continued access to sterile devices.
For this goal to be achieved, the FDA has employed various strategies, such as:
✓ Regulatory flexibility
✓ Supply chain analysis
✓ Collaboration
✓ Innovation
✓ Effective & transparent communication:
During the town hall meeting, the FDA:
✓ Discussed challenges and activities regarding medical device sterilization which led up to a 2019 Advisory Committee meeting focused on EtO.
✓ Revised the major points of discussion and related FDA activities, from the Advisory Committee meeting.
✓ Described the medical device sterilization landscape and supply chain integrity.
✓ Discussed the importance of looking forward and involvement in collaborative activities as well as the role of the new series of sterilization town halls.
12th January 2024: The Division of Mammography Quality Standards posted “Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA).”
BACKGROUND:
On March 10TH 2023: The FDA issued the FINAL RULE AMENDING THE MQSA REGULATIONS.
The new updates are to be applied by the mammography facilities within 18 months after the publication, hence, no later than SEPTEMBER 10TH, 2024.
The post made on JANUARY 12TH by the division of Mammography quality standards was made to:
✓ Help facilities prepare for the annual inspection.
✓ Provide additional information regarding the rule amendments.
26th January 2024: The second FDA Town Hall on medical device sterilization was held.
This meeting was held to:
✓ Describe the actions the FDA took to assure the U.S. sterilization capacity.
✓ Review recent activities to reduce the EtO, while keeping a resilient supply of sterilized medical devices.
✓ Discuss the understanding of the FDA on challenges and opportunities faced when using alternative sterilization methods.
✓ Describe the creation of an EtO Tiger team responsible for advancing innovations in medical device sterilization.
31st January 2024: Quality management system regulation (QMSR) final rule
The FDA issued a Quality Management System Regulation (QMSR) Final Rule to promote consistency in regulating medical devices.
✓ It amends the device’s current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).
✓ Incorporates international standards for medical devices set by the International Organisation for Standardization (ISO), e.g. the ISO 13485.
IMPORTANT: This rule will be effective on February 2 nd , 2026, manufacturers are required to comply with the QS regulations until then.
European Union 2024
Medical Device Updates
1st January 2024: MDCG Guidance on the vigilance system for CE-marked devices – DSVG 00 – Device Specific Vigilance Guidance (DSVG) Template
The guidance on the vigilance system for CE-marked devices (DSVG) was updated with the aim of:
✓ Providing further guidance for vigilance reports of specific devices to the manufacturers and the relevant Competent Authority.
✓ Outlining the correct procedure for reporting incidents to the relevant Competent Authority.
1st January 2024: MDCG Guidance on the vigilance system for CE-marked devices – DSVG 01 – Devices for Cardiac Ablation
The guidance on the device specific vigilance system (DSVG) for Cardiac Ablation devices was updated with the aim of:
✓ Providing further guidance for vigilance reports of Cardiac Ablation devices to the manufacturers and the relevant Competent Authority.
✓ Outlining the correct procedure for reporting incidents to the relevant Competent Authority.
2nd January 2024: MDCG Guidance on the vigilance system for CE-marked devices – DSVG 02 – Coronary Stents and Associated Delivery Systems
The guidance on the device-specific vigilance system (DSVG) for Coronary Stents and associated delivery systems was updated with the aim of:
✓ Providing further guidance for vigilance reports of Cardiac Ablation devices to the manufacturers and the relevant Competent Authority.
✓ Outlining the correct procedure for reporting incidents to the relevant Competent Authority.
3rd January 2024: MDCG Guidance on the vigilance system for CE-marked devices – DSVG 03 – Cardiac Implantable Electronic Devices (CIEDs)
The guidance on the device-specific vigilance system (DSVG) for Cardiac implantable electronic devices and their leads (CIEDs) was updated with the aim of:
✓ Providing further guidance for vigilance reports of Cardiac implantable electronic devices and their leads (CIEDs) to the manufacturers and the relevant Competent Authority.
✓ Outlining the correct procedure for reporting incidents to the relevant Competent Authority.
Source: mdcg_2024-1-3_en.pdf (europa.eu)
4th January 2024: MDCG Guidance on the vigilance system for CE-marked devices – DSVG 04 – Breast Implants
The guidance on the device-specific vigilance system (DSVG) for Breast implants was updated with the aim of:
✓ Providing further guidance for vigilance reports of Breast implants to the manufacturers and the relevant Competent Authority.
✓ Outlining the correct procedure for reporting incidents to the relevant Competent Authority.
Source: mdcg_2024-1-4_en.pdf (europa.eu), https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorseddocuments-and-other-guidance_en
17th January 2024: Overview of the language requirements for manufacturers of medical devices
The commission and member states have created the MDR and IVDR table with the aim of:
✓ Helping manufacturers of medical devices understand the language requirements for the instructions and the required written information accompanying a medical device.
✓ Providing an overview of the language requirements for each Member State.
January 2024: Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).
In 2017, a new regulation on in vitro diagnostic medical devices was introduced as part of a new legislative framework for medical devices. This framework aimed to:
✓ Enhance safety standards.
✓ Ensure smooth functioning of the internal market.
The joint implementation plan endorsed by the MDCG aims to:
✓ serve as a guideline.
✓ outline priorities.
✓ monitor implementation progress.
With a focus on ensuring:
✓ patient safety.
✓ public health.
✓ regulatory transparency.
All information is taken from: https://health.ec.europa.eu/medical-devices-vitro-diagnostics_en?wt-search=yes, 558ede8b-ff9a-4a8f-bb9dd61e4a515b6a_en (europa.eu)
24th January 2024: The European Commission proposes an extension for the implementation of the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).
This extension aims to provide manufacturers with more time to comply with the IVDR, without compromising patient safety.
✓ High-risk in vitro diagnostic devices – will have a transition period until 27th December 2027.
✓ Lower-risk devices – will have time until December 2029.
As current data shows, many in vitro diagnostic devices do not meet the new regulatory standards. Therefore, the preparatory work for a targeted evaluation of the medical devices will start this year by the Commission which will assess how the legislation affects the availability of medical devices.
Source: European Commission proposes extended IVDR transition – Med-Tech Innovation (med-technews.com)