On 5 December 2024, the French Government was forced to resign following the vote of non-confidence by the French National Assembly towards the Social Security Financing Bill (“PLFSS”). A new Government was then appointed on 23 December 2024. As a result, 2024 ended without a PLFSS for 2025, leaving the Pharma and MedTech industries in uncertainty, particularly regarding the safeguard clause mechanism. A Special Law To Prevent From Any Shutdown The PLFSS is debated…
After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? This is the fourth post in our EHDS series. In this post, we focus on the new product regime for electronic health record (EHR) systems, including the impact on wellness apps, AI systems and medical devices. We examine the latest publicly available draft, dated 24…
The UK’s MHRA has published a statement of policy intent for recognition of international regulators’ approvals of medical devices in Great Britain (GB). If your organisation’s medical device is authorised in any of Australia, Canada, the EU, or USA (together, Comparable Regulator Countries or CRCs), you may be able to leverage this to gain fast-tracked access to the GB market. This means that manufacturers may be able to side-step the full UK authorisation process for…
On 24 April 2024, the European Commission announced the launch of a formal investigation into the measures put in place and practices followed by China in its public procurement of medical devices. The announcement responds to the Commission’s belief that these measures and practices favour domestic Chinese suppliers whilst putting EU companies at a clear disadvantage. The investigation will be carried out under the EU’s International Procurement Instrument (IPI), a trade tool that aims to…
To future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 20231. As a new independent regulator, the EDC will replace the Ministry of Health and Prevention (MOHAP) for the regulation of pharmaceuticals and medical devices. Besides medicines and medical devices the EDC will also be responsible for cosmetics, dietary supplements, GMOs, fertilizers, pesticides, agricultural conditioners and plant growth regulators. The EDC will also take over some competences from the Ministry of Climate Change and Environment…
The Corporate Sustainability Due Diligence Directive (“CS3D”), provisionally agreed in December 2023, will create significant behavioural and reporting obligations for many EU and non-EU healthcare and life sciences companies active in the EU, adding an additional layer of compliance and complexity to their already highly intricateglobal value chains. In this first instalment of our new “CS3D Explainer Series”, we provide an overview of scope, key obligations and relevant timeline under the CS3D.
In brief As we look back at 2023, we reflect on a year marked by significant developments in the legal framework governing the life sciences and healthcare industries in the US. These developments include the implementation of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act; the rise of artificial intelligence in drug development and manufacturing; the evolving landscape of US Food and Drug Administration regulation and enforcement of laboratory-developed tests; and the…
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a new roadmap setting out its timeline for an overhaul of the UK medical device regulations. The MHRA is taking a phased approach, with new legislation pencilled in for 2024 on Post Market Surveillance (PMS) and in 2025 for a wider core framework. Current plans indicate certain areas of alignment with the requirements of the EU Medical Devices Regulation (EU MDR). The MHRA further…
Manufacturers of Machine Learning-Enabled Medical Devices (MLMDs) face a key challenge: existing requirements and processes on the notification and management of ‘substantial’ and ‘significant’ changes to medical devices need adapting for MLMDs. The MHRA, together with the U.S. Food and Drug Administration (FDA) and Health Canada, has published five guiding principles on predetermined change control plans (PCCPs) to help resolve this tension. What is the tension between AI and change management for medical devices? Some…
In brief On 26 June 2023, the Spanish National Court annulled the evaluation system of newly approved medicinal products based on Therapeutic Positioning Reports (“ITPs”) set up by the Spanish Ministry of Health in 2020 (“Plan”). The Court based its decision on the grounds that (1) the system was created without following the legal procedure, and (2) was approved by a body that did not have the authority to do so. The Court concludes that…