Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in Germany.Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon
Medical Devices
FDA to Convene Advisory Committee Meeting on GenAI Mental Health Devices
The Food and Drug Administration (FDA) has announced that its Digital Health Advisory Committee (DHAC) will meet on November 6, 2025, to discuss and make recommendations on the topic of genAI-enabled digital mental health medical devices. The DHAC will discuss potential “benefits, risks to health, and risk mitigations” for such devices, “including premarket evidence and postmarket monitoring considerations.”Continue Reading FDA to Convene Advisory Committee Meeting on GenAI Mental Health Devices
MHRA Issues Statement of Policy Intent Regarding Early Access to Innovative Medical Devices
By Sarah Cowlishaw & Dan Spivey on
Posted in Medical Devices
On 31 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (“Early Access Service”). Although this statement is non-binding, it indicates further efforts by the MHRA to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval – in line with Action 25 of the Life Sciences Sector Plan (published on 16 July 2025).Continue Reading MHRA Issues Statement of Policy Intent Regarding Early Access to Innovative Medical Devices
MHRA Announces Consultation Response on Reforms to GB Pre-Market Medical Device Regulation
By Sarah Cowlishaw, Roderick Dirkzwager & Dan Spivey on
Posted in Medical Devices
On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published the outcome of its most recent medical device-related consultation. The MHRA also announced its intention to consult further on the indefinite recognition of CE-marked medical devices in Great Britain, with this consultation expected to take place later in 2025.Continue Reading MHRA Announces Consultation Response on Reforms to GB Pre-Market Medical Device Regulation