April Medical Device Regulatory Updates – Russell Regulatory Consultants Ltd

April Medical Device
Regulatory Updates

United Kingdom 2024

Medical Device Updates

2nd April 2024: NHS England in groundbreaking artificial pancreas use

Local NHS boards are beginning work to identify eligible adults and children living with Type 1
diabetes, who may benefit from an ‘artificial pancreas’. The device is completely novel and will
monitor the individual’s blood glucose levels continually and release insulin as they require,
through a pump system. Also known as a Hybrid Closed Loop System, it was approved for rollout
in NHS England by NICE (The National Institute of Health Care and Excellence) in December
2023.

✓ Diabetes is one of the most common chronic diseases in the UK. NHS England spends
around £10 billion annually on managing Diabetes.

✓ Around 8% of people with diabetes have Type 1, it is a chronic condition where the
pancreas fails to release enough insulin, a hormone that regulates blood glucose levels.
The condition can be life threatening, causing hypoglycaemic/hyperglycaemic episodes,
which can cause seizures, coma and death.

✓ It is estimated around 105,000 people with the condition could benefit from use of this
device.

✓ Type 1 Diabetics ordinarily must manually record their blood glucose levels and manage
them by injecting themselves with insulin as they require it. This device could eradicate
the need to do this.

✓ NHS England has published a 5-year implementation strategy.

2nd April 2024: Cancer Research UK to fund new ‘hydrogel lollipop’

Cancer Research UK and the Engineering and Physical Sciences Research Council are funding a
project developed by researchers from the University of Birmingham designed to aide in the
diagnosis of mouth cancer.

✓ Over 10,000 people in the UK are diagnosed with head and neck cancers every year.

✓ The lollipops, made from hydrogel, are designed to capture proteins which can then be
analysed for the presence of cancerous cells.

✓ Dr Ruchi Gupta from University of Brimingham has been awarded £350,000 over the
next three years to develop the prototype.

✓ Researchers are welcoming further collaborators in order to continue development

✓ It is thought that similar products, utilising hydrogels, may prove beneficial in
diagnostics.

Source: University of Birmingham scientists using novel hydrogel to create ‘lollipops’ for mouth cancer diagnostic – Med-Tech Innovation (med-technews.com), Scientists to make ‘lollipops’ to aid mouth cancer diagnosis (cancerresearchuk.org), Birmingham scientists win funding to develop ‘lollipops’ for mouth cancer diagnosis – University of Birmingham

24th April 2024: NHS endorsed hologram technology awarded European grant

Horizon Europe – the EU’s key funding programme for health tech for research and innovation –
has granted HoloSurge 8.9 million euros to continue development into their technology,
Holocare. Holocare is an interactive, 3D organ hologram programme which allows surgeons to
see organs from a different perspective, giving them better insight into individual anatomy, and
providing a valuable tool to combat complications during surgery.

✓ The HoloSurge project, led by Norwegian company Holocare, brings together 14
different partners from 10 European countries.

✓ Despite Brexit, the UK are involved in this European scheme, which is seen as an
exciting opportunity to collaborate with Europe’s health leaders.

✓ Initially for use in liver surgery, trials have shown 74% reduction in time taken to align
organs during surgery

✓ The user will wear a Microsoft HoloLens – an augmented reality headset – in
combination with the technology.

✓ Believed to improve clinical decision making and reduce the risk of complications.

Source: Horizon Europe – European Commission (europa.eu), HoloSurge awarded €8.9 million Horizon Europe
grant to improve surgical planning with hologram technology – Med-Tech Innovation (med-technews.com),
HoloSurge: Holographic Guidance System for Interventions on Liver and Pancreatic Cancers – SINTEF

United States 2024

Medical Device Updates

15th April 2024: FDA recall Abbott heart pumps due to deaths

The FDA have recalled the HeartMate II and Heart Mate 3 Left Ventricular Assist System (LVAS)
following the devices being linked to 273 reported injuries and at least 14 deaths. The devices are
manufactured by Thoratec Corp., an Abbott subsidiary. The FDA advises this is a recall for
correction and the devices will not be removed from the market, but the advice is not to use them
as they are likely to cause injury.

✓ The pumps are designed to help the heart pump blood in patients with end-stage heart
failure when heart transplant is not an option.

✓ The recall affects nearly 14,000 devices.

✓ The device failure is due to “Extrinsic Outflow Graft Obstruction (EOGO), which occurs
when biological material builds up and causes obstruction within the device, affecting
the blood flow.

Source: Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to
Long-term Buildup Causing an Obstruction | FDA, FDA recalls Abbott heart pumps linked to deaths, injuries – Chicago
Sun-Times (suntimes.com)

17th April 2024: FDA CDRH document updates

The FDA Center for Devices and Radiological Health (CDRH) is responsible for protecting and
promoting public health – their mission is to ensure patients and providers “have timely and
continued access to safe, effective, and high-quality medical devices and safe radiation-emitting
products”. They aim to continually strive to provide up to date, science-based evidence to
facilitate their mission. They have released updated documents on the FDA website.

✓ CDRH 2024 Innovation Report (April 2024) (download (fda.gov))

✓ CDRH 2024 Safety Report (April 2024) (download (fda.gov)).

Source: Medical Device Safety and Innovation Reports | FDA, Center for Devices and Radiological Health | FDA

19th April 2024: FDA announces next Town Hall on Sterilization

The FDA have made a commitment to reducing reliance on EtO (Ethylene Oxide) sterilization,
despite the fact it is the most commonly used method, primarily due to EtO often being the only
method used to sterilize devices without damaging them. It is estimated that 50% of all devices
in the US are sterilized using this method. However, EtO is a carcinogen and comes under the
US Environmental Protection Agency (EPA) regulations. There are additional concerns about the
environmental impact, as well as supply chain interruptions of sterilized devices.

✓ Alternative methods include moist/dry heat, radiation, hydrogen peroxide, chlorine
dioxide, vaporized peracetic acid.

✓ Suggested ways to reduce EtO reliance so far include product packaging changes,
optimized processes, reduced exposure times and reduced gas concentrations.

✓ EtO is particularly used for devices made from certain polymers, metals, or glass, as
well as devices with multi-layer packaging or hard to reach areas as it is less likely to
cause damage.

✓ The FDA are encouraging manufacturers to report any supply shortage issues to enable
them to plan and attempt to prevent adverse effects on public safety.

SOURCE: FDA Panel Addresses EtO Sterilization | PDA, Medical Device Sterilization Town Hall: Topics and Formats for
the Continuing Sterilization Series – 04/29/2024 | FDA, This Week at FDA: Califf faces appropriations grilling,
Woodcock’s next steps, warning letters, and more | RAPS, Preventing Medical Device Shortages by Ensuring Safe and
Effective Sterilization in Manufacturing | FDA

European Union 2024

Medical Device Updates

18 April 2024: Medical Device Coordination Group (MDCG) issues
guidance on safety reporting to align with the IVDR

The In Vitro Diagnostic Medical Devices Regulation (IVDR) advises manufacturers to report any
serious adverse events to all member states in which performance studies are being performed,
as soon as possible after occurrence, to align with the legislation.

✓ The In Vitro released a 23-page document, which includes guidelines on how to report an
incident, the timelines to follow and how to assess causality.

✓ The most serious events must be reported with two calendar days. All other safety
incidents should be reported within seven calendar days.

✓ Any serious event relating to the device, the comparator or the study procedure should be
reported, as well as any device deficiency that might have led to a serious incident, or any
new findings following an event such as this having occurred.

✓ To allow for timely reporting, the manufacturer is allowed to submit an incomplete report
with the final report to follow.

Source: MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under
Regulation (EU) 2017/746 – April 2024 – European Commission (europa.eu), 5cc894e0-331d-4fa2-8ab3-
cdd4437c48fc_en (europa.eu)

24th April 2024: China’s procurement of medical devices to be investigated by the EU

China’s methods in procuring medical devices have faced ongoing accusations of
discrimination towards EU countries and will now be investigated – it is claimed they have been
using unfair tactics to reduce the amount of European sourced medical devices on the Chinese
market, instead opting for Chinese made devices.

✓ Initiated following feedback from multiple member countries of the EU into their
experiences in attempting to access the Chinese market.

✓ Slow certification processes and unclear guidelines for EU countries have been flagged
as being unfair

✓ If the accusations are found to be true, China could face being cut off from the 2 trillion
Euro European market.

✓ The investigation is the first to be opened under the new EU trade tool, The
International Procurement Instrument (IPI).

Source: eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uric=OJ:C_202402973, EU to China: Open your public
markets or we’ll close ours – POLITICO, International public procurement instrument: securing fairness for EU firms |
News | European Parliament (europa.eu), The EU’s International Procurement Instrument – IPI | EUR-Lex (europa.eu)

29th April 2024: Virus v Bacteria Software achieves EU MDR certification

Antimicrobial Resistance (AMR) has become a severe threat to global health. AMR occurs when
bacteria, viruses, fungi, and parasites no longer respond to antimicrobial medicines. It is
believed AMR has been directly responsible for millions of deaths worldwide and been a
contributory factor in millions more. Smart Blood Analytics Swiss (SBAS) uses AI to analyse
blood samples to determine the most likely diagnoses. It can more accurately and efficiently
interpret blood results.

✓ It facilitates clinicians in distinguishing between viral and bacterial infections, which
allows them to treat patients with the correct medicines – overuse and incorrect use of
antimicrobials has contributed directly to AMR.

✓ Known as VIRUS vs. BACTERIA Clinician Decision Support Software, it is the first of
its kind to receive EU MDR certification in the field of infectious disease management.

✓ It differentiates between viral and bacterial infections based on 17 different routine
blood test results

✓ More intervention into AMR called for at the 2022 G20 Bali Summit – SBAS software is
the response.

Source: Smart Blood Analytics, Antimicrobial resistance (who.int), Smart Blood Analytics Swiss Achieves EU-MDR
Certification for VIRUS vs. BACTERIA Model (prnewswire.co.uk)