Avoiding Regulatory Roadblocks: 5 critical mistakes medical device companies make

As medical device companies bring new innovations to market, navigating the complex regulatory landscape can make or break a product’s success. From classification errors to incomplete documentation, small missteps can cause major delays, particularly when engaging with European regulators under MDR (EU) 2017/745. Understanding common pitfalls is the first step to avoiding them. 1. Underestimating […]

Brexit Poses Challenges for Medical Devices Companies as UK Goes Its Own Way

While it has been nearly two years since the UK withdrew from the European Union, much still remains uncertain about the direction that the Medicines and Healthcare product Regulatory Agency (MHRA) will take with its requirements. Will change happen, and if so when? It’s a bit of a baptism by fire with the regulators only […]