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.
What is a class 1 Medical Device?
A Class 1 medical device represents the lowest risk category of medical devices. Despite being classified as low risk, these devices are still subject to regulatory oversight to ensure their safety, performance, and compliance with relevant standards.
How to identify the legal manufacturer for medical devices
The term “Legal Manufacturer” is one that has been floated about a lot in the last few years. However, it is not actually defined anywhere in EU legislation.
Documents of External Origin: Do I have to revalidate?
When a harmonised standard is revised, the answer to whether you need to revalidate your processes isn't straightforward - but a gap assessment between your QMS and the updated standard is always a good place to start.
Review your Technical Documentation like a Notified Body (or UK Approved Body)
A practical walkthrough of what Notified Bodies actually look for when reviewing medical device technical documentation, covering everything from intended purpose and regulatory classification through to risk management and pre-submission checks.
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