Regulatory Blog

If you're developing a medical device or in vitro diagnostic (IVD) and need clarity on UK regulatory requirements, the MHRA offers a dedicated paid advisory meeting service. This guidance, " Medical devices: get regulatory advice from the MHRA " is particularly useful when the application of existing regulations to your specific device or situation isn't straightforward. Here's a full breakdown of how the service works. What it's for The service is designed to provide regulat

Placing a medical device or in vitro diagnostic (IVD) on the UK market involves more than product design and manufacturing. Manufacturers must demonstrate regulatory compliance, engage effectively with regulators, and prepare for evolving post-market expectations. To support this, the UK government and the Medicines and Healthcare products Regulatory Agency (MHRA) have published a series of guidances and roadmaps that explain both current requirements and the future direction