This digest covers key virtual and digital health regulatory and public policy developments during February 2024.

Of note, the UK continues to pursue a “pro innovation” flexible approach to the regulation of AI. As outlined in the UK government’s response to the public consultation, the government will develop a set of core principles for regulating AI, while leaving regulatory authorities, like the Medicines and Healthcare products Regulatory Agency (MHRA), discretion over how the principles apply in their respective sectors. A central governmental function will coordinate regulation across sectors and encourage collaboration. The government’s aim with this approach is to enable the UK to remain flexible to address the changing AI landscape, while being robust enough to address key concerns. This is in sharp contrast to the position in the EU, where the EU AI Act is reaching the conclusion of the legislative process.Continue Reading Virtual and Digital Health Digest, March 2024

On 23 January 2024, the European Commission announced proposals to amend the Medical Device Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (IVDR), as applicable, to:

  • extend the transition provisions for certain in vitro diagnostic medical devices (IVDs) under the IVDR
  • allow for a gradual roll-out of Eudamed so that certain modules will be mandatory from late 2025
  • include a notification obligation in case of interruption of supply

The proposal will now need to be adopted by the European Parliament and Council before it enters into force. However, as the proposal follows a similar structure to the recent amendments to the MDR, we do not anticipate significant changes during the legislative process.Continue Reading Commission proposes extension to IVDR transition periods and accelerated launch of Eudamed

Post-Brexit, the MHRA has been consulting on the future medical devices regulations, and how to retain the UK’s position as an attractive place to launch devices. As part of this, there have been a number of recent announcements about the medical devices regime in the UK.

  • On 27 April 2023, the MHRA updated its guidance on the implementation of the future medical devices regulations (the UK Regulations) to confirm the intention for the “core aspects” of the UK Regulations to apply from 1 July 2025.
  • The UK government has also introduced legislation that will be finalised before 30 June 2023 to allow valid EU CE marked medical devices to continue to be placed on the market in Great Britain. The extended periods will align with the transitional periods under the new UK Regulations.
  • On 26 May 2023, a proposed new regulatory pathway, the Innovative Devices Access Pathway (IDAP), set for pilot launch later in 2023, was announced, published as part of a suite of announcements that we will cover in a separate post.

Stakeholders will no doubt be pleased to hear of the development to extend the validity of EU CE marking in Great Britain, which allows for more realistic timeframes for manufacturers to obtain a UKCA mark, given the current state of flux of the UK medical device market following Brexit and the COVID-19 pandemic. The proposed IDAP pilot will also be a welcome development, and is another step taken by the MHRA to enhance innovation and stimulate interest in the UK medical devices industry, ahead of the implementation of the new UK medical devices regime in 2025.Continue Reading UK Medical Devices Update: Implementation of the UK Medical Devices Regulations and new Innovative Devices Access Pathway

With much fanfare, in January 2023, the European Commission released its proposal to extend the MDR transition periods and abolish the ‘sell-off’ deadline, after which medical devices and in vitro diagnostics (IVDs) would have to be withdrawn from the EU and EEA market. Today, the proposal has been adopted via Regulation 2023/607 (the Regulation), and will come into force today, 20 March 2023. This date is now important, as CE certificates that expired before today may be able to be considered as valid if certain conditions are met. Certificates that expire from today until the new transition periods will be considered as valid if the conditions set out below are met. This provides important breathing space for companies and should ensure that a large number of devices are not withdrawn from the market over the next year.Continue Reading Extension to EU MDR transition periods finalised

It is well known that there are significant problems with the implementation of the Medical Devices Regulation 2017/745 (MDR), in particular notified body capacity and the vast number of products that need to go through the new regime before the end of the transitional period. After sustained pressure from companies and Member States alike, late last week (on 9 December), the Commission finally confirmed that it intends to extend the transitional period under the MDR. Member States are said to have agreed with the proposals. We set out a summary of what is known so far below.
Continue Reading Delay to EU MDR is on the horizon

Welcome to the first installment of Arnold & Porter’s Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space. This newsletter focuses on key virtual and digital health and telehealth-related developments in the United States, United Kingdom, and European Union in the healthcare, regulatory, privacy, and corporate transactions space.
Continue Reading Virtual and Digital Health Digest

On 26 June 2022, the MHRA published the UK Government’s response to the consultation on the regulatory framework for medical devices in the UK (the Response), and following analysis of the nearly 900 responses received, its intentions for the future UK regulatory regime for medical devices (the UK Regulations).

In September 2021, we posted about the MHRA’s consultation, with a summary of the proposals set out across 15 technical chapters.  The consultation ran between September and November 2021, and focused on patient safety and innovation, whilst recognising that gaining and maintaining competitiveness in a global market will be best supported by aligning with internationally recognised best practice and standards.

We have considered the Response and set out some of the key factors we consider to be of particular interest below. We have not precisely follow the order in the Response and have not covered every aspect or changes; this is necessarily a high level summary.

While the approach the MHRA intends to take in the UK Regulations is clarified and set out in more detail in the Response, no draft statutory text has yet been published. A lot of detail will also be left to guidance that will accompany the UK Regulations. It will therefore be important to see how closely aligned the new UK framework is to the proposals described in the Response and with international rules and standards.Continue Reading MHRA response to consultation on the regulation of medical devices

As of today, the 26 May 2022, the in vitro diagnostic Medical Devices Regulation (EU 2017/746) (IVDR) applies across the EU.

Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done. In this post, we provide an overview of the current status of the transitional provisions, identify recently published guidance, and briefly consider the position in the UK and Switzerland.Continue Reading The EU IVDR is here!

On 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices was published in the Official Journal of the EU. This Regulation sets out a stronger role for the EMA in managing public health crises, and aims to formalise the ad-hoc structures and processes that have been used by the EMA during the COVID-19 pandemic. The intention is that these ad hoc process can now serve as a blueprint for a more harmonised EU response to future public health emergencies.

The reinforced role of the EMA is seen as an important development for the European Health Union. It aims to ensure that the EU is better prepared to manage future health crises by tackling shortages of medicines and medical devices more effectively and to develop medical countermeasures to address the threats posed to public health at an early stage and in a harmonised way. As part of this, the Regulation sets out important provisions on monitoring shortages of medicines and devices, and a greater role of the EMA in overseeing medical devices.Continue Reading New EU Regulation Reinforcing the Role of the EMA