March Medical Device Regulatory Updates
United Kingdom 2024
Medical Device Updates
11th March 2024: Mhra Has Taken Measures To Promote Equity In The Medical Devices Environment
✓ Providing guidance to manufacturers and developers on the improvement of diversity in all areas such as testing, investigation and the development of medical devices.
✓ Strengthening their vigilance role by listening and engaging with patients and the public, ensuring continuance of a high degree of protection.
Source: https://www.gov.uk/government/news/mhra-response-to-equity-in-medical-devices-independent-review
The government has announced action to tackle bias in the design and use of medical devices, with some action already underway:
✓ The MHRA now requests that new medical device applications must describe how they plan to address any bias.
✓ NHS guidance has been updated to highlight the limitations of pulse oximeters in use with patients with dark skin colour.
✓ The National Institute for Health and care research (NIHR) is now accepting funding applications for research into smarter oximeters.
The government will also:
✓ Work with the MHRA to make sure regulations for medical devices are safe for patients, regardless of their background.
✓ Continue work to remove racial bias from data collection.
✓ Support ongoing work within NHS England, aiming to focus on training personnel, on issues including health equity.
✓ Work with partners to improve the transparency of data used in the development of medical devices using AI.
The dates for the March and April 2024 webinars were added:
✓ Thursday 21st March 2024 at 3pm
✓ Tuesday 26th March at 2pm
✓ Monday 15th April at 3pm
✓ Monday 29th April at 3pm
The MHRA are warning the public not to buy any unbranded devices as they do not comply with regulations. They estimate that over 10,000 counterfeit devices have been purchased
Furthermore, they have advised that the general public:
✓ Make sure to buy from a reputable seller.
✓ Ensure their devices are UKCA or CE marked.
✓ To check that the device is registered with the MHRA, via the public access database (PARD (mhra.gov.uk)).
✓ Be advised that none of the devices registered with the MHRA are manufactured in China so any products which they find are, should be treated with caution and disposed of.
The MHRA is working on the improvement of online marketplaces to remove unbranded anti-choking devices from sales.
Source: https://www.gov.uk/government/news/mhra-warns-of-unsafe-counterfeit-anti-choking-devices
United States 2024
Medical Device Updates
The Breakthrough Devices Program, replacing the Expedited Access Pathway and Priority Review for medical devices, is a voluntary program aimed at manufacturers of potentially innovative devices and device-led combination products which may offer more effective treatment or diagnosis of irreversibly debilitating diseases or conditions. It aims to reduce the amount of time it takes for these devices to gain regulatory approval and therefore become accessible to patients.
✓ The update has included the Device Designations Data and Market Authorizations list.
✓ Manufacturers with devices accepted to this program can expect prioritized review of their submission.
✓ A Breakthrough designation request must be sent before sending for a marketing submission.
✓ Confirmation of whether the FDA has approved or denied the Breakthrough Device designation request will be returned within 60 days of receiving the request.
Source: FDA Roundup: March 22, 2024 | FDA, Breakthrough Devices Program | FDA
The Medline Autologous Regeneration of Tissue (ART) Skin Harvesting System is a novel device, which is designed to obtain a patient’s healthy skin tissue from one area of their body and deposit it onto their skin graft-appropriate wound site.
✓ It allows harvest and graft of multiple small plugs of healthy tissue, under local anesthesia, in a less invasive manner and in a wider range of healthcare settings.
✓ The device manufacturer, Medline, claims to strive to “achieve both clinical and financial success in an environment that demands lower costs and better outcomes”.
SOURCE: FDA Roundup: March 29, 2024 | FDA, About Us – Medline Corius
European Union 2024
Medical Device Updates
The EU Commission and Member States have created two new tables, one for MDR and one for IVDR, giving an overview of language requirements relating to their devices in specific countries.
✓ Aims to help medical device manufacturers, particularly small and medium-sized, understand the language requirements of each country.
✓ This is intended for application to all device accompanying information and instructions.
✓ The tables also include language requirement information relating to graphic user interface (GUI), which can be found in apps.
The Medical Device Coordination Group, endorsed by the EU Member States and European Commission, has released a new document containing guidance on the required content of a Clinical Investigation Plan for clinical investigations of medical devices.
✓ The guidance is based on the MDR and ISO 14155: 2020 Clinical investigation of medical devices for human subjects – Good clinician practice. Although not a mandatory resource under MDR, it remains strongly recommended for use.
✓ The document should be considered as best practice as it has been developed with contribution from national competent authorities, industry, and relevant stakeholders.
✓ It is intended to support medical device companies wishing to undertake clinical investigation, guiding them on not only what content to include in their plan but be able to meet the requirements set out by the competent authorities during assessment of their clinical investigation application.