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Articles by Ellie Handy
Don’t get lost – How femtech can navigate the EU medical device and AI rules
Femtech, short for female technology, is an important and fast growing sector. The EU is a key market for femtech, with five of the top 10 countries for femtech investment located in the EU. Femtech products are developed for many areas of women’s health, such as menstrual health, pregnancy planning and monitoring, menopause and mental wellbeing.
The Double-Edged Sword of AI in FemTech in the EU
AI presents many opportunities in the women’s health space, but it can also pose considerable risks. Anyone seeking to commercialise AI-enabled femtech products in the EU needs to be aware of the impact of the EU’s Regulation (EU) 2024/1689 (the AI Act) as it can impose onerous regulatory obligations. This article considers the demands imposed by the EU’s medical device regulations and the EU AI Act, and how this could impact femtech products.
Ellie Handy
Ellie is a dual-qualified lawyer in England & Wales and Ireland who advises on EU and UK life sciences regulatory law. Ellie focuses on pharmaceutical and medical device matters. Ellie has extensive experience working for medical technology companies and tech clients working in the software and AI space.
A Wellcome Development for SaMD – the UK Publishes Guidance on Digital Mental Health Technologies (via Passle)
The MHRA and NICE published guidance on “Digital mental health technology: qualification and classification” (the DMHT Guidance) last week. It was developed as part of a Wellcome funded project on digital mental health technologies (DMHTs). The DMHT Guidance is the latest guidance from the MHRA in the software as a medical device (SaMD) space. Interestingly, on the question of qualification of DMHTs, the MHRA will consider both the intended purpose and the functionality of a technology.
WHO Publishes Regulatory Considerations on AI for Health
On October 19, 2023, the World Health Organization (“WHO”) published a set of regulatory considerations on artificial intelligence (“AI”) for health (press release and full publication).
UK Government Announces Launch of Pilot Scheme to Accelerate Access to Innovative Medical Devices
On 19 September 2023, the UK Government announced the launch of the Innovative Devices Access Pathway (“IDAP”) pilot scheme. The UK already has in place an Innovative Licensing and Access Pathway (“ILAP”) for medicines. IDAP is the equivalent for medical devices, and is groundbreaking in the UK devices space. The IDAP scheme aims to improve access to innovative and transformative medical devices, and meet unmet patient needs. Currently, it is in a pilot phase.
Fast-Tacking Approval of Medicines - UK Publishes Detailed Guidance on its New International Recognition Procedure
On 30 August 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) published detailed guidance on its recently announced new International Reliance Procedure (“IRP”) (see our prior blog and audiocast). The IRP will apply from 1 January 2024 and will replace and significantly expand on existing EU reliance procedures to apply to authorizations from 7 key international regulators.
EU Talking Life Sciences Audiocast: The UK's Medicinal Product and Medical Device Reliance Routes
She has developed considerable expertise in GxP, including adverse event reporting, quality systems and manufacturing, supply chains and recalls. She regularly counsels clients on “Brexit” related issues from both a UK, EU and Irish perspective. Marie also advises on, and performs regulatory due diligence for, corporate/commercial transactions including acquisitions, public offerings and clinical trial agreements.
EU Talking Life Sciences Audiocast: The UK’s Medicinal Product and Medical Device Reliance Routes
Click here to listen to the audio Tune into this episode of Covington’s Life Sciences Audiocast, where Grant Castle, Marie Doyle Rossi, and Ellie Handy discuss the UK’s recent announcement of new international reliance routes for medicinal products and medical devices. The speakers will discuss existing EU reliance procedures offered by the UK.
EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle
Hot on the heels of recent announcements from the U.S. Food and Drug Administration (see our prior blogs here), the European Medicines Agency (“EMA”) has joined the conversation on the use of Artificial Intelligence (“AI”) and Machine Learning (“ML”) technologies in the medicinal product lifecycle. AI and ML have the potential to enhance every stage of the medicinal product lifecycle, from drug discovery, through to clinical development, manufacturing and post-market pharmacovigilance.
Fast-Tracking Access to New Medicines - UK Announces New International Reliance Route
On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products. This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations.
Fast-Tracking Access to New Medicines - UK Announces New International Reliance Route
On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products. This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations.
EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations
Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.” The TEMA will be an “agile, fast and streamlined” process to allow products to be developed and made available as soon...
EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations
Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.” The TEMA will be an “agile, fast and streamlined” process to allow products to be developed and made available as soon...
EU Pharma Legislation Review Series: National MA Procedures Including the Mutual Recognition Procedure and Decentralized Procedure
The European Commission (the “Commission”) wants to “avoid unnecessary administrative and financial burdens for applicants and competent authorities.” As such, the Commission’s proposal for a revised Directive on the Union Code Relating to Medicinal Products for Human Use (the “Directive”) retains the Decentralized Procedure (“DCP”) and Mutual Recognition Procedure (“MRP”). Chapter III of the Directive sets out the new procedures for national marketing authorizations (“MAs”).
EU Pharma Legislation Review Series: AMR and Transferable Exclusivity Vouchers
The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”). At the same time, the measures are also aimed at promoting and incentivizing the development of new priority antimicrobials through the use of transferable data exclusivity vouchers.
EU Pharma Legislation Review Series: AMR and Transferable Exclusivity Vouchers
The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”). At the same time, the measures are also aimed at promoting and incentivizing the development of new priority antimicrobials through the use of transferable data exclusivity vouchers.
EU Pharma Legislation Review Series: Regulatory Data Protection
The European Commission (“Commission”) intends to change the rules on regulatory data protection (“RDP”) of medicinal products.
EU Pharma Legislation Review Series: Orphan Medicines
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU pharmaceutical legislation. The proposal includes a new draft Regulation, which will repeal Regulation (EC) No 726/2004, the Orphan Medicines Regulation 141/2000 and the Paediatric Regulation 1901/2006. As expected, the draft Regulation significantly shakes up incentives available to the developers of orphan medicines.
EU Pharma Legislation Review Series: Orphan Medicines
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU pharmaceutical legislation. The proposal includes a new draft Regulation, which will repeal Regulation (EC) No 726/2004, the Orphan Medicines Regulation 141/2000 and the Paediatric Regulation 1901/2006. As expected, the draft Regulation significantly shakes up incentives available to the developers of orphan medicines.
EU Pharma Legislation Review Series: Regulatory Data Protection
The European Commission (“Commission”) intends to change the rules on regulatory data protection (“RDP”) of medicinal products.
Talking Life Sciences Audiocast: Medical Devices - Key Recent Developments
Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.
How do the recent changes to the MDR and IVDR impact you and your medical devices? - Top 10 Questions
To avoid a real and imminent risk of shortages of devices on the EU market, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU) 2017/745 (the “MDR”) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”). The Commission has published a Q&A on the practical aspects of the latest changes (the “Q&A”).
EU Talking Life Sciences Audiocast: Episode 2 - Key Developments in the Medical Device Sector - State of Play in the EU and UK
Tune into the second episode of Covington’s Life Sciences Audiocast, where Sarah Cowlishaw, Ellie Handy, and Léna Beley discuss key developments in the medical device sector in the EU and the UK.
EU Talking Life Sciences Audiocast: Episode 2 - Key Developments in the Medical Device Sector - State of Play in the EU and UK
Click here to listen to the audio Tune into the second episode of Covington’s Life Sciences Audiocast, where Sarah Cowlishaw, Ellie Handy, and Léna Beley discuss key developments in the medical device sector in the EU and the UK.
UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
Grant Castle is a partner in the London office practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management. He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products.
UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation Original
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritise. Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals, plus changes to the regulation and support of digital technologies and artificial intelligence (“AI”).
Change is Coming for Software and AI Medical Devices in the UK
The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”).
Notified body capacity needed! MDCG proposals recognize need to increase notified body capacity to ensure device availability
The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies. It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not undergoing timely conformity assessments under Regulation (EU) 2017/745 (the “MDR”) or Regulation (EU) 2017/746 (the “IVDR”) (together, the “Regulations”)).
Notified body capacity needed! MDCG proposals recognize need to increase notified body capacity to ensure device availability
The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies. It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not undergoing timely conformity assessments under Regulation (EU) 2017/745 (the “MDR”) or Regulation (EU) 2017/746 (the “IVDR”) (together, the “Regulations”)).
U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices
On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).
U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices
On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).
Consultation on the Future Regulation of Medical Devices in the UK, including Work Programme for Software and AI Medical Devices
The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021.
CJEU Confirms that CBD is Not a Narcotic Drug
In a landmark judgment on 19 November 2020, the CJEU ruled in Case C-663/18 that cannabidiol (“CBD”) is not a narcotic drug under the UN Conventions. This is the case even where the CBD is derived from the whole cannabis plant. The ruling provides clarity on the non-controlled status of CBD and the free movement of CBD products within the Union. This is likely to have wide implications for the CBD industry.
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