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

Developments in product liability law are always potentially significant for pharmaceutical and medical device manufacturers.

On 13 March 2024, the European Parliament adopted new EU consumer protection legislation to repeal and replace the EU Product Liability Directive 85/374/EEC, which has been in force for almost 40 years.  Once the new legislation has been approved by the European Council it will become law, and is likely to come into force in around mid-2026. The intention is for EU consumers to have easier access to compensation caused by defective products. 

The International Comparative Legal Guide (ICLG) on Product Liability Laws and Regulations 2024 is now available, and we have prepared:

Continue Reading Implications of the New EU Product Liability Directive

This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2024.

You will note that France has set out new pricing rates for innovative digital therapeutic medical devices under the accelerated market access pathway, known as PECAN. While the pathway was set out in February 2023, the lack of reimbursement rates means up-take has been low. The order of April 22, 2024 introduces the new pricing structure, with the maximum amount of financial compensation set at €780 per year, per patient. This is an important step in ensuring digital therapeutic products can be widely available in France while also ensuring that developers can obtain appropriate reimbursement.

Continue Reading Virtual and Digital Health Digest, May 2024

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

The EU Health Technology Assessment (HTA) Regulation (Regulation (EU) 2021/2282), which entered into force in January 2022, will start to apply from January 2025 for oncology medicines, advanced therapy medicinal products and medical devices (the HTA Regulation will apply to orphan medicines from 13 January 2028, and all centrally authorised medicines from 13 January 2030).

The HTA Regulation aims to accelerate access to innovative health technologies. Currently, new technologies undergo national-level assessments to evaluate their costs effectiveness, and have to meet national pricing and reimbursement (P&R) requirements to determine if they will be made available on the national healthcare system. This is a costly process, both in economic, and time and resource terms.

The HTA Regulation seeks to increase cooperation across Europe, to ensure the efficient use of resources and strengthen the quality of HTAs. At the heart of the HTA Regulation lies the introduction of EU-level joint clinical assessments (JCAs), which are collaborative assessments, including resources and expertise from different EU Member States. With relevant data only needing to be submitted once within the EU, JCAs will minimize duplication and alleviate the workload for companies and authorities. Under the HTA Regulation, HTA bodies in the Member States are expected to consider the JCA reports in their decision-making processes, but the ultimate decision on whether a particular product will be available and reimbursed on the national healthcare system will remain the competence of the national authority.

Ahead of its introduction, several measures are being introduced, as set out in the Implementation Rolling Plan published by the Commission. These include a number of implementing acts,  IT projects and EU support such as capacity building, training and awareness raising. As part of this, in the past few weeks, the Commission has published information on the evaluation of parameters used in JCA dossiers and a draft Implementing Regulation on JCAs.

Continue Reading Preparing for the implementation of the EU Health Technology Assessment Regulation

The revised transparency rules governing the transparency of information submitted to the Clinical Trial Information System (CTIS), as adopted by the European Medicines Agency (EMA) on 5 October 2023, will come into effect on 18 June 2024, thesame day thenew CTIS portal will launch. The CTIS, established under the Clinical Trials Regulation (EU) No 536/2014 (CTR), aims at facilitating the information exchange on trials in the European Union (EU). It operates on the principle of public disclosure, with the exception of information relating to personal data and Commercially Confidential Information (CCI).

Preparation is crucial for sponsors conducting clinical trials in the EU as they may need to adapt ongoing trial documentation and future submissions. Our blog post sets out the key changes and provides tips for preparation.

Continue Reading Getting Ready for the Upcoming Revised EMA CTIS Transparency Rules

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