Regulatory Rapporteur February 2026 – Contents
MedTech in transition: Regulation, risk and real-world impact
Reckoning with risk: Navigating MedTech innovation
Navigating regulatory scrutiny: An analysis of requests for information in EU combined clinical trials
Parenteral drug delivery systems: Driving clinical success
Wearable technology: The fine regulatory line between health and wellness
From design to diversity: Embedding women’s health into medical device innovation and regulation
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DIN SPEC 91509: A milestone for structured, digital medical device documentation
This industry news update introduces a new model that will help with the digitalisation of documentation under EU law.
MHRA points to clinical trial growth and faster assessment routes
This industry news update shares how clinical trials have grown over the past year and new regulations coming into effect.
MHRA invites Call for Evidence to assess AI regulation
This industry news update explains the reason for the MHRA’s Call for Evidence for AI regulation and provides guidance.
More news
FDA and EMA publish guiding principles of good AI practice in drug development
This industry news updates shares the ten principles of best practice for AI.
Saudi FDA vision to be a leading regulator includes updating guidance on combination products
This industry news updates shares Saudi FDA’s updated guidance for combination products.
EC proposes regulation to simplify rules on medical and in vitro diagnostic devices
This industry news update shares the EC’saim to simplify medical and IVD device rules through a new proposal.
The VMD changes how it calculates adverse events incidents for animals
This industry news update shares the VMD’s changes to how it calculates adverse events, which has now taken full effect.
RegRapPod − InConversation with Parexel
InConversation talks Joint Clinical Assessment with Sangeeta Budhia and Sinan Sarac
RegRapPod − InConversation with Zohra Nasir and Aksa Rahman
InConversation talks careers with Zohra Nasir and Aksa Rahman
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