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…
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…
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…
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 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…
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…
On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission Communication.
The Communication, while directed towards the broader biotech sector, refers to the aim to…
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…
This digest covers key virtual and digital health regulatory and public policy developments during January 2024.…
A version of this article was first published in Life Sciences IP Review
There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply that have to be adapted to specific AI technologies. As a step towards a more coherent approach, the government…
