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 the UK General Election on 4 July, the Labour Party won 412 of the 650 seats, giving it a comfortable majority. Its leader, Sir Keir Starmer, became Prime Minister, meaning a change of government from Conversative to Labour for the first time in 14 years.

In its campaign, Labour focused on the need to deliver economic growth and innovation in critical industry sectors. It also placed considerable emphasis on addressing the problems facing the National Health Service (NHS), such as long waiting lists for treatment, old equipment and an increasingly ageing population.

The government’s economic priorities were further set out in the first major speech delivered by the new Chancellor of the Exchequer Rachel Reeves on 8 July, in which she said that growth “is now our national mission”. The Health Secretary Wes Streeting also noted his intention of making the Department of Health and Social Care a department for economic growth. While each of these are statements of intent and not binding on the new government, they provide valuable insight into what industry can expect over the next 5 years. We set out below some of the most relevant initiatives that could impact the industry.

Continue Reading What does the new UK government mean for life sciences?

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

The Court of Justice of the EU (CJEU) has provided guidance on claims permitted to be made in the labelling and advertising for biocidal products under the Biocidal Products Regulation (Regulation (EU) No 528/2012 (BPR). 

The BPR aims to improve the free movement of biocidal products (substances intended to destroy, deter, render harmless, prevent the action of or otherwise control harmful organisms) while ensuring a high level of protection for human and animal health and the environment.

Continue Reading CJEU rules on biocidal product advertising

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 24 April 2024, the European Parliament formally adopted the Regulation on Standards of quality and safety for Substances of Human Origin (SoHo) intended for human application (the SoHO Regulation). On the same date, the European Commission published a Questions & Answers (Q&A) document on the SoHO Regulation. Then on 27 May 2024, the EU Council adopted the new rules. For the final step in the legislative process, the new Regulation is due to be published in the Official Journal shortly.

The SoHO Regulation aims to introduce new and innovative measures to help ensure that high standards of safety and quality for SoHO are maintained across the EU and that SoHO activities are appropriately regulated.  A key goal is to facilitate cross-border exchanges and access to SoHOs across the EU, while ensuring high levels of health for donors, recipients and offspring from medically assisted reproduction. A more harmonised approach to the regulation of SoHO across the EU is envisaged, which will be welcomed by industry. However, Member States may still diverge and include more stringent measures under their national laws. The extent to which one Member State’s authorisation of a SoHO Entity, SoHO establishment or SoHO preparation is really “EU wide” therefore remains to be seen. Furthermore, the success of the SoHO Regulation is reliant upon cooperation and coordination between Member States, including the use of the SoHO Platform and seeking opinions from the SoHO Coordination Board on borderline issues. This will require continuous contact between Member States and a good understanding of the ever-developing and innovative uses of SoHOs. Guidance accompanying the new rules, as well as what measures need to be put in place from the outset, will need to be informative, clear and proportionate for the SoHO Regulation to make the differences it is intended to achieve.

Continue Reading European Parliament adopts Regulation on substances of human origin (SoHO)

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