July Medical Device Regulatory Updates
European Union 2024
Medical Device Updates
2nd July 2024 – Updated MDCG guidance released on standardisation of medical devices
✓ MDCG 2021-5 Rev. 1 was released to provide an updated explanation on various aspects of medical device standards, relating to the latest EU regulation requirements.
✓ The update includes removal of references to older guidelines, with reference made to the new legislation.
✓ The update also includes reference made to EN ISO 15189 and ISO 14155:2011.
✓ Discussion includes what is considered to be international standardisation of medical devices, as well as what is considered “state of the art” is also included.
Source: 59ac4cb0-f187-4ca2-814d-82c42cde5408_en (europa.eu)
4th July 2024 – European Commission present an information session on MDR/IVDR
✓ Reiterated the need for manufacturers to have an MDR QMS in place and have made an application for conformity assessment for their device – both measures should have been taken by 26th May 2024. Furthermore, manufacturers should have a signed contract in place with their chosen Notified Body by 26th September 2024.
✓ Recommended documentation to have in place to confirm that a device is covered by the extended transitional period – Manufacturer’s Declaration, Notified Body Confirmation Letter and Free Sale Certificate.
✓ Confirmed that 31st December 2028 is the end of the transition period for all medical devices.
✓ Also confirmed IVDR transitional period guidelines
Source: Information session on MDR/IVDR for international regulators – 4 July 2024 – European Commission (europa.eu), 93e2d43c9da8-40b1-b6d8-8f36962c92f9_en (europa.eu)
8th July 2024 – Updated MDCG guidance released on Classification Rules for in vitro Diagnostic Medical Devices under Regulation 2017/746
✓ MDCG 2020-16 Rev. 3 has been released to provide updated clarification on classification rules found in Annex VIII and should be considered in conjunction with the IVDR.
✓ This document provides guidance on how to classify IVD devices prior to placing them on the market but is also intended to inform regulators and others when assessing the risk classification given to an IVD.
✓ It provides a list of definitions, rationale for classification and explanation of the individual rules.
Source: 12f9756a-1e0d-4aed-9783-d948553f1705_en (europa.eu)
9th July 2024 – Regulation (EU) 2024/1860 takes effect, with particular attention paid to ensuring the availability of IVDs
✓ Following the European Commission’s proposal in January 2024, this regulation amendment refers to changes to Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). It was particularly driven by concerns on the availability of some IVDs.
✓ The document underpins several key themes, including; – the continued gradual rollout of Eudamed to encourage smooth implementation; – albeit the number of notified bodies has increased, there is still a shortfall in requirement; – in particular, the effect of shortcomings is predicted to affect in vitro diagnostic devices and fears have grown over possible interruption to market supply of these products; – to this end, an extension to the time IVD manufacturers have to conduct conformity assessments has been put in place, and in order to maintain safety, the length of time required to achieve conformity will be dependent on device risk class; – there is now an obligation on manufacturers, where they can reasonably anticipate, shortages or disruption to supply of their devices, should inform competent authorities, economic operators and any other stakeholders of these possibilities in order to promote maintenance of patient.
✓ MedTech Europe have published a template to facilitate the declaration of manufacturers with respect to the amendments, which can be found here – Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860 – MedTech Europe.
Source: : eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401860, bsi-md-ivdr-amending-regulation-faqs-en-gb.pdf (bsigroup.com), dfd7a1c6-f319-4682-9bac-77bef1165818_en (europa.eu)
9th July 2024 – WHO launches MeDevIS platform
✓ The World Health Organisation have launched the Medical Devices Information System or ‘MeDevIS’. It aims to support would-be medical device consumers to be able to make informed decisions on device selection and procurement.
✓ This online platform will house information on 2301 different types of medical devices for a broad range of uses and aims to replace paper-based literature search across multiple platforms in order for users to efficiently collect reliable data on devices, to facilitate decision making.
✓ MeDevIS will reference the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN).
✓ WHO reports this will boost access to medical technologies and devices.
Source: MeDevIS platform announced to boost access to medical technologies and devices (who.int), WHO launches an online platform for information on medical devices (news-medical.net)
10th July 2024 – European Commission issue updated timeline for the gradual rollout of Eudamed
✓ The European Database on Medical Devices or Eudamed is designed to contain information such as, registration details of devices and details of the economic operators, information regarding clinical investigations, CE mark certificates, vigilance and post market surveillance information. Eudamed is designed for use as a tracking system for medical devices on the EU market.
✓ It is made up of six modules, three of which are already in operation but on a voluntary basis. The final three modules are still to be launched.
✓ The aim is eventually for all EU market medical devices to be traceable through the Eudamed system. The updated timeline, which can be accessed below, will give specific details.
✓ WHO reports this will boost access to medical technologies and devices.
Source: 04ce2012-97df-4dd0-8a39-d4f6993b9e16_en (europa.eu)
12th July 2024 – EU Competent Authorities release Consensus Statement on the status of the EU regulatory system
✓ The statement addressed the European Commission’s ‘targeted evaluation of the regulations’, advising the body is in agreement with the requirement for evaluation. It went on to identify the challenges faced by all stakeholders in the transition to and implementation of the MDR and IVDR. It is hoped that publication of this statement will demonstrate their willingness to work together to achieve a ‘predictable, reliable, secure and efficient regulatory system in Europe based on the MDR and IVDR’
✓ It referred to increased costs, unpredictability of outcomes, risk of supply issues and decreased access to innovation as being the cause of widespread ‘uncertainty and hesitation’ over transitioning to the new regulations.
✓ The statement warned that if the issues were left unaddressed, health and enterprise across Europe could be negatively impacted. It reiterated the vital importance of public protection while supporting innovation and access to new technologies in Europe. The competent authorities have called upon the European Commission to ‘clearly prioritise medical devices in their next mandate’.
Source: Medical Devices and In Vitro Diagnostics Regulations: publication of a consensus statement from the EU Competent Authorities to the EU Commission – CAMD : CAMD (camd-europe.eu), 2024_07_MDCA_Statement-final.pdf
United Kingdom 2024
Medical Device Updates
31st July 2024 – Wristband used to control Tourette’s Syndrome symptoms achieves £500k investment
✓ From a Nottingham University spin out, the device is designed to stimulate the median nerve which runs through the wrist, with the aim of controlling involuntary movements caused by Tourette’s Syndrome
✓ With view to achieving approval in the UK, Europe and US, the investment will allow the manufacturer, Neupulse to conduct trials and achieve growth.
✓ Tourette’s Syndrome is thought to affect 2% children worldwide, with a lack of available treatment options.
Source: University of Nottingham spinout secures £500k for Tourette’s therapy wristband – Med-Tech Innovation (medtechnews.com), Neupulse – Improving the lives of people with Tourettes
24th July 2024 – GMDN receive funding from Innovate UK to focus on gathering post-market surveillance information
✓ The Global Medical Device Nomenclature Agency, as well as other partners have gained the investment with view to using the information gathered from post-market surveillance to improve device safety and efficacy
✓ The project raises the idea that post-market surveillance hasn’t changed in many years but with advancing technology, this project aims to keep up with the changes and update the way we achieve post-market intelligence.
Source: GMDN agency receive innovate UK funding – Medical Plastics News, Innovate UK – UKRI
23rd July 2024 – InnoScot Health appoint new regulatory specialist
✓ The new appointment will be responsible for InnoScot Health’s Quality Management System, with the aim to taking the NHS Scotland partner ‘to the next level’.
✓ The aim is to continue to provide high quality regulatory advice in order to maximise the growth and potential of Scotland’s medical devices.
Source: New regulatory appointment can help take formal NHS Scotland partner to ‘next level’ – Med-Tech Innovation (medtechnews.com), InnoScot Health
24th July 2024 – Tydeman Tube launches across the UK – a Russell Regulatory project!
✓ Considered a revolutionary and innovative device, the Tydeman Tube is a result of collaboration between Dr Graham Tydeman, an NHS Fife consultant obstetrician, Guys’ and St Thomas’ NHS Foundation Trust and Rocket Medical Plc. It is designed to facilitate during Caesarean Section procedures, with early feedback from clinicians being extremely positive in its ability to improve mother and baby outcomes.
✓ The Tydeman Tube is available in the UK through Rocket Medical and NHS Supply Chain, with view to it being released globally in the near future.
✓ It’s with great pride that we at Russell Regulatory look back on our involvement in this project.
Source: The Tydeman® Tube – An Innovative Medical Device to Facilitate Delivery of the Impacted Fetal Head at Caesarean Section | Pressat, The Tydeman® Tube – An Innovative Medical Device Developed for Facilitating Delivery of the Impacted Fetal Head During Caesarean Section Procedures – SME Bulletin
United States 2024
Medical Device Updates
10th July 2024 – FDA continues Town Hall focus on alternative sterilization methods
✓ There are ongoing concerns about the safety of the most widely used sterilization method, ethylene oxide. Alternative methods consider include gas chemical sterilant and radiation.
✓ The FDA reports they are committed to reducing the reliance on ethylene oxide sterilization use, while ensuring the integrity of the supply chain. They have adopted a ‘multi-pronged’ approach, as well as continued Town Halls addressing the issue
✓ The format of this edition was different – they held a mock Pre-Submission meeting focused on medical device sterilization.
✓ The next session – scheduled for 7th August 2024, will deliver a live Q&A session based on the information heard during this segment.
Source: https://www.youtube.com/watch?v=xQCYpaswH-I&feature=youtu.be, download (fda.gov), download (fda.gov)
29th July 2024 – FDA approves blood test for colon cancer detection, hailed as a ‘new era’
✓ Guardant Health’s Shield Blood Test approved as a primary screening option in Colorectal Cancer detection following performance within range of current guideline-recommended non-invasive screening methods, demonstrating 83% sensitivity in detection.
✓ Colorectal cancer or CRC is the second-leading cause of cancer-related death in the US. The Shield blood test has been researched and developed over the last 10 years.
✓ Guardant Health are committed to leading oncology precision therapies.
✓ This decision follows strong recommendation for approval by an Advisory Committee panel in May.
Source: Guardant Health, Inc. – Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening, Home – Guardant Health, May 23, 2024: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement – 05/23/2024 | FDA
29th July 2024 – San Diego University research team device can measure activity in human cervical nerves, a world first
✓ The device is wearable and non-invasive. It is designed to record neural activity from the vagus and carotid sinus nerves as well as other autonomic nerves found in the skin and muscle of the neck.
✓ The involuntary nervous system can influence digestion, heart rate and the immune system.
✓ The vagus nerve plays a crucial role in sepsis research and it is hoped this device will have the ability to interpret complex biological signals and play a key role in early detection of life-threatening illness.
✓ InflammaSense is the name of the manufacturer delivering this innovation.
Source: Non-invasive ventral cervical magnetoneurography as a proxy of in vivo lipopolysaccharide-induced inflammation | Communications Biology (nature.com), InflammaSense – Inflammation as a Vital Sign