In our recent blog post, we reviewed the overall impact of the new EU AI Act on the life sciences industry. The AI Act (Regulation (EU) 2024/1689), which entered into force on 1 August 2024, is the world’s first comprehensive law regulating artificial intelligence (AI). While some provisions are already applicable, the
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Virtual and Digital Health Digest – August 2024
This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024 from United Kingdom, and European Union.
Following the UK national elections on July 4, 2024, which brought in a new government, the King delivered a speech to Parliament setting out the government’s key legislative and policy…
The EU AI Act: Impact on the Life Sciences Industry
Much has been written about the EU AI Act, which has now been published in the Official Journal as Regulation (EU) 2024/1689 and entered into force on 1 August 2024.
The AI Act is so-called “horizontal legislation”, meaning it applies across industries, and its impact will be felt from agriculture to aerospace and beyond. …
Virtual and Digital Health Digest – July 2024
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…
The King’s Speech: Product Safety and Metrology Bill
By Tom Fox & Libby Amos-Stone
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…
What does the new UK government mean for life sciences?
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…
Transition periods under the IVDR extended
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…
CJEU rules on biocidal product advertising
By Tom Fox
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…
Virtual and Digital Health Digest – June 2024
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.…
European Parliament adopts Regulation on substances of human origin (SoHO)
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…