Temporary Regulatory Flexibilities

In its Inspectorate Blog the MHRA published a post on temporary changes in Good Distribution Practice (GDP) entitled “How to manage temporary GDP process changes and risks through the COVID-19 pandemic”…

What do you want to do?

What do you want to do? Provide Information. When do you want to give it to us? Ummmm… OK, you might have been more definite in your final answer. But was it what the MHRA Inspector wanted to hear? Or see in your SOP’s? Particularly with regards to information on...

Changes in Medical Device Regulation 1.

There have been major regulatory changes within the Medical Device market, with more coming in the form of the Medical Device Regulations (MDR) which is in the process of being implemented at the moment. The main change that has affected the market over the last...