Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners. The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024.Continue Reading UK HRA Consults on a New Model Investigator-Initiated Study Agreement
The European Union has adopted various new rules for emergency situations relating to public health. These new measures build on the experience gained from the COVID-19 pandemic and give new powers to the European Commission, in close cooperation with the Member States.
The new rules create a complex public health crisis management system. Measures that
On March 11, 2023, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”). The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the design and use of medical devices. The Government Response fully accepts, and in turn makes a series of commitments in response to, the findings of the Review (which is broken down into 18 recommendations, 51 sub-recommendations, and 3 further calls to action). Importantly, the Government “wholeheartedly agrees…that medical technology should be unbiased and equitable.”
Bias in the medical device space, and within healthcare more broadly is (quite rightly) a topic of growing importance to governments, regulators and industry alike. We set out some key points of interest from both the Review and the Government Response below. We look forward to seeing more developments and guidance in this area going forwards given its significance to patients and the delivery of healthcare. Continue Reading UK Government Outlines New Action to Tackle Biases in Medical Devices
In a move that is sure to be welcomed by the diagnostics industry, on 23 January 2024, the European Commission announced proposals (Commission proposal and press release) to extend the transitional periods for certain in-vitro-diagnostic medical devices (“IVDs”) under Regulation (EU) 2017/746 (“IVDR”). This follows similar action taken by the Commission in early 2023 to extend the transitional provisions under Regulation (EU) 2017/745 (the “MDR”) (see our prior blog post here). The rationale applied for the latest proposal is the same as before – it aims to “ensure availability of safe devices, essential for healthcare systems, and protect patient care”. Specifically, the latest IVD proposals are intended to address ongoing concerns regarding the availability and readiness of notified bodies to perform IVDR conformity assessments and the high number of IVDs that have yet to transition to the IVDR. The new proposals (once adopted) will provide manufacturers with more time to comply with the new requirements of the IVDR. Relatedly, manufacturers will be required to give notice if they foresee interruption of supply of their devices.
In addition, to improve the transparency and coordination, the Commission has proposed to accelerate the roll out of the European database on medical devices (“EUDAMED”) so that certain modules are mandatory as from late 2025. Continue Reading European Commission Proposes to Extend Transitional Periods for In-Vitro-Diagnostic Medical Devices
The European Parliament and Council are currently negotiating the wording of a new Regulation establishing a Single Market emergency instrument (“SMEI”). This new measure builds on the experience gained from the COVID-19 crisis and gives new powers to the Commission, in close cooperation with the Member States. This blog briefly discusses the expected impact on
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). The publication is not guidance or policy but is intended as a resource for relevant stakeholders in medical devices ecosystems, including manufacturers who design and develop AI-embedded
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
Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market.
The move is a significant reversal of the UK’s previous, post‑Brexit policy. In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark. However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely. Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it. Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU. What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers.
Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”). The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.Continue Reading UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)
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
Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear. Uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences for developers and innovators. To