Medical Devices

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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

On 15 May 2024, the Court of Appeal (CoA) handed down a unanimous judgment that a medical device manufacturer could not obtain interim relief to prevent its UK Approved Body (UKAB), BSI, suspending a certificate on grounds of safety and non-conformities before a substantive decision in the manufacturer’s judicial review claim. The judgment overturns the first instance decision granting the manufacturer an injunction and mandatory order against BSI.

The CoA judgment emphasises courts’ deference to expert regulators, particularly in matters of public health, and that courts are unwilling to restrain a public authority in exercising its powers in good faith, particularly when there is an argument concerning public health. The judgment also reaffirms the principle that the burden is on the manufacturer to demonstrate to the satisfaction of the UKAB the safety and performance of a device. Given this is the first decided case challenging the decision of an Approved Body, there are a number of implications for the UK framework and the relationship with the EU.

Continue Reading Court of Appeal rules on suspension of UKCA certificates

On 21 May 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent (the Statement) setting out its proposals for international recognition of regulatory “approvals” of medical devices. Under the proposed scheme, medical devices will be subject to limited pre-market requirements where they are already “approved” in a trusted jurisdiction. This will replace the current provisions, which permit recognition of EU CE marks, and will expand recognition to a wider set of trusted regulators, including the US in certain cases. This has long been an intention of the MHRA, and follows a similar procedure for medicines announced last year, although the practicalities of how this will work for devices and the role of the relevant stakeholders has been difficult to resolve.

The proposals are intended to avoid duplication of assessments for medical devices and it is hoped this will lead to quicker access to new devices in Great Britain. It will also allow the MHRA to meet its stated aim of focusing resources on innovative devices, particularly artificial intelligence medical devices (AIMD) that are excluded from the scheme.  However, the Statement is silent on who will undertake the reviews required under the access routes. This is subject to ongoing consultation, though it seems likely that any reviews would be conducted by UK Approved Bodies. This will require coordination between Approved Bodies and the MHRA, which will be an important step in ensuring this scheme operates as intended.

The MHRA intends that the new recognition scheme will come into force at the same time as the future core changes to the medical devices regulatory framework in Great Britain, discussed in a previous post. It is expected the draft regulations implementing that scheme will be published later this year, with the regulations coming into force in 2025.

Continue Reading MHRA outlines proposals for international recognition of medical devices

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to artificial intelligence (AI). The publication is in response to the request from the Secretaries of State of DSIT and DHSC dated 1 February 2024, in which the MHRA was asked to provide details about what steps it is taking in accordance with the principles and expectations of the Government’s pro-innovation approach set out in the white paper published in 2023. Further information is set out in our previous post.

The strategy provides information on how the MHRA views the risks and opportunities of AI from three perspectives:

  • MHRA as a regulator of AI products
  • MHRA as a public service organisation delivering time-critical decisions
  • MHRA as an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties

The document is likely to be of particular interest to AIaMD manufacturers as it sets out in detail current and proposed regulations and guidance, and areas where this is likely to be tightened. Following the launch of the strategic approach, the government also published details of the AI Airlock regulatory sandbox, discussed in another post.

With a raft of measures relating to AI being published and additional measures expected in the next couple of years, pharmaceutical and medical device companies operating in the UK need to continually review how they will be impacted and respond appropriately.

Continue Reading MHRA sets out its AI regulatory strategy

In our blog post on 22 February 2024 we reported on the Medicines and Healthcare products Regulatory Agency (MHRA) announcement that it intended to launch a regulatory sandbox for software and AI medical devices called the “AI-Airlock”. The pilot project went live on 9 May 2024, and government sources are citing it as a key component of the MHRA’s strategic approach to AI, published on 30 April 2024 (discussed in a separate post).

Continue Reading The MHRA’s “AI Airlock” – what do you need to know?

On 6 May 2024, the U.S. Food and Drug Administration (FDA) published its highly anticipated final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests or LDTs).

Historically, FDA exercised enforcement discretion for LDTs, declining to impose its device authority over such tests in most instances. Under the new final rule, LDT manufacturers that generally operated outside FDA oversight will now be expected to come into compliance with FDA requirements and controls applicable to their tests. In consideration of this substantial operational and compliance burden, the preamble to the final rule details a phaseout policy under which FDA will gradually end its general LDT enforcement discretion policy in five phases over a four-year period, as follows:

Continue Reading What you need to know about the FDA Laboratory Developed Test Final Rule

This digest covers key virtual and digital health regulatory and public policy developments during March.

You will note that the EU institutions have been busy during March. On March 12, 2024, the European Parliament (EP) formally adopted the revised Product Liability Directive, which makes several important changes to the existing European Union (EU) product liability regime, including that software and artificial intelligence (AI) technologies will now fall within the scope of a product. On March 13, 2024, the EP formally adopted the Artificial Intelligence Act, meaning the legislative process for the world’s first binding law on AI is nearing its conclusion. Finally, on March 15, 2024, the Council of the European Union and the EP reached a provisional agreement on the European Health Data Space (EHDS), which aims to improve access to health data electronically across the EU. Each of these important legislative provisions should shortly be finalized and will then become law in the EU.

Continue Reading Virtual and Digital Health Digest, April 2024