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UK Med. Dev Guidance: UKCA Marking, MHRA Regulatory Advice, and the Future Medical Device & IVD Regime
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
Sharan Murugan
21 hours ago3 min read