Medical Devices

Subscribe to Medical Devices via RSS

This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2024 from the United Kingdom and European Union.

Guidance on AI continues to be published. In the EU, the European Medicines Agency (EMA) has published its Reflection Paper on the use of AI throughout the medicines life cycle. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) opened applications for its AI Airlock, a regulatory sandbox for AI as Medical Devices. And over 100 companies have signed up to join the EU AI Pact, a voluntary initiative to encourage companies to comply with the AI Act before the statutory deadlines. These guidance documents and initiatives provide companies with much greater clarity on how the authorities will regulate the use of AI in health care.

Continue Reading Virtual and Digital Health Digest – October 2024

On 23 October 2024, the European Parliament adopted a resolution on the urgent need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

This resolution acknowledges that the MDR and IVDR were adopted to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices in the EU, to ensure higher standards of safety, transparency and clinical performance, while also fostering innovation in the sector. However, it is also acknowledges that significant challenges have been encountered in implementing the MDR and the IVDR. These include delays, shortages, and difficulties in navigating the regulatory procedures. The particular impact on small and medium sized enterprises (SME) and on patient care are highlighted.

The lack of harmonised procedures for Notified Bodies, and the lack of harmonised interpretation of the MDR and IVDR between Notified Bodies, is also noted, and the fact that this leads to unpredictable timelines for certification and market access.

The Parliament resolution therefore seeks to address some of these difficulties.

Continue Reading European Parliament resolution on need to revise the Medical Devices Regulation

This digest covers key virtual and digital health regulatory and public policy developments during August and early September 2024 from United Kingdom, and European Union.

There have been some important reimbursement updates this month. In France, the French health regulator has issued a negative opinion on the first digital therapeutic that sought reimbursement through the PECAN pathway. This opinion suggests that while PECAN provides a more streamlined process by not requiring formal clinical trials, the regulator still expects robust data to show that the digital therapeutic is worthy of reimbursement. In the UK, the National Institute for Health and Care Excellence has published a position paper that highlights the risks of using AI for generating and reporting evidence for health technology assessments. It sets out that the use of AI in this context should be limited to situations where the value of doing so can be clearly demonstrated, and sets out guidance for companies on how to present such data and to justify the use of AI. Health technology assessment seems to be an area where AI has more readily been accepted, and industry will welcome guidance on the parameters around such use.

Continue Reading Virtual and Digital Health Digest – September 2024

In our recent blog post, we reviewed the overall impact of the new EU AI Act on the life sciences industry. The AI Act (Regulation (EU) 2024/1689), which entered into force on 1 August 2024, is the world’s first comprehensive law regulating artificial intelligence (AI). While some provisions are already applicable, the provisions relating to high risk AI systems, which are those most likely to impact the life sciences industry, will apply from 2 August 2027.

Continue Reading The European AI office and other resources relevant to high risk AI systems

This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024  from United Kingdom, and European Union.

Following the UK national elections on July 4, 2024, which brought in a new government, the King delivered a speech to Parliament setting out the government’s key legislative and policy agenda. Of particular importance to the life sciences sector are the Product Safety and Metrology Bill and the Digital Information and Smart Data Bill. Although the scope and content of each bill is currently unknown, they could impact medical devices and innovative scientific research. Further, there was no artificial intelligence bill in the agenda, although the government will “seek to establish the appropriate legislation” in the future.

Continue Reading Virtual and Digital Health Digest – August 2024

Much has been written about the EU AI Act, which has now been published in the Official Journal as Regulation (EU) 2024/1689  and entered into force on 1 August 2024.

The AI Act is so-called “horizontal legislation”, meaning it applies across industries, and its impact will be felt from agriculture to aerospace and beyond. …

This digest covers key virtual and digital health regulatory and public policy developments during June 2024 from United Kingdom, and European Union.

While it has been a relatively quiet month in the EU given elections in the European Parliament and in the UK (as well as other countries across the EU), agencies across the globe have published important guidance on machine-learning enabled medical devices. This includes the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) guiding principles on transparency, published together with the U.S. Food and Drug Administration (FDA) and Health Canada, and the International Medical Device Regulators Forum (IMDRF) consultation on its guiding principles on good machine learning practice (which itself follows similar guidance from MHRA, FDA, and Health Canada in 2021). This demonstrates the increased importance of international standards in this area and the need for coordination between regulatory authorities to standardize guidance for these products.

Continue Reading Virtual and Digital Health Digest – July 2024

Following the outcome of the national election on 4 July 2024, on 17 July 2024, King Charles III gave a speech to the UK Parliament in which, as directed by the new Government, he outlined the key points of its legislative and policy agenda.

The agenda includes a Product Safety and Metrology Bill.  Some form of legislation to address UK product regulation was expected in order to take account of market developments and new technologies, such as online selling and AI.  We set out below a brief summary of the Bill.

Continue Reading The King’s Speech: Product Safety and Metrology Bill

In our previous blog post, we set out the Commission’s proposed amendments to the Medical Devices Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR). The new Regulation introducing these changes has now been published: Regulation (EU) 2024/1860.

The new Regulation includes a welcome extension to the transitional periods for certain IVDs under the IVDR, where applicable conditions have been met. The other proposals relate to a gradual roll-out of Eudamed and notification obligations for interruptions in supply.

Continue Reading Transition periods under the IVDR extended

This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2024 from United Kingdom, and European Union.

Of interest, artificial intelligence (AI) safety has been in focus over the past month, including with the publication of the Interim International Scientific Report on the Safety of Advanced AI. International collaboration in this area is increasing as world leaders met at the AI Summit in Seoul, and the UK government recently announced a collaboration on AI safety with Canada, supplementing its existing commitment with France. Further, the UK launched the AI safety evaluations platform, which is available to the global community. In the meantime, the EU has established an AI Office to oversee the implementation of the AI Act and the Medicines and Healthcare products Regulatory Agency (MHRA) has published its AI Airlock to address novel challenges in the regulation of artificial intelligence medical devices (AIaMD).

Continue Reading Virtual and Digital Health Digest – June 2024