Regulatory Blog

The Health Products Regulatory Authority (HPRA) has released updated guidance documents to strengthen pharmaceutical quality systems, regulatory compliance, and operational oversight across Ireland’s healthcare sector. The updated guidance documents include: Guide to Quality System for General Sale Wholesale Distributors Guide to Pre-submission Scientific and Regulatory Advice for GXP Activities Guide to Managing Changes to Registrations of Active Substance Manufacturers, Imp

To support industry stakeholders, the UK Medicines and Healthcare products Regulatory Agency (MHRA) offers a dedicated Regulatory Advice Meeting service for medical devices and in vitro diagnostic devices (IVDs). This service helps organisations better understand regulatory expectations, clarify complex requirements, and navigate the UK regulatory system more effectively. The MHRA guidance titled “Medical devices: get regulatory advice from the MHRA” explains how manufacturer

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