Practical perspectives on medical device regulation
Insights to navigate regulation, bring medical technologies to market, and improve patient care.
EU Authorised Representative
Navigating the complexities of EU medical device regulations is crucial for manufacturers, particularly those outside the European Union.
How to Register Medical Devices in the UK: A Comprehensive Guide for UK and International Manufacturers
Registering medical devices in the UK is essential for manufacturers aiming to market their products in Great Britain (England, Scotland, and Wales).
Everything you need to know about UK Responsible Person (UKRP) for Medical Devices
We break down the role of a UKRP, why it’s essential for compliance, and what to look for when choosing the right one for your business.
What is the latest with the UK Medical Devices Regulations
The MHRA is moving towards international recognition of medical device approvals from comparable regulators including the EU, FDA, Health Canada and TGA, while also pioneering the AI Airlock, a world-first regulatory sandbox to support the safe development of AI as a medical device.
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